Pediatric CancerINTERACTNCT04706676
Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer
A study testing Integrative neuromuscular training (INT) and motivational counseling session in people with Pediatric Cancer and Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial summary
The INTERACT study is a nation-wide, population-based randomized controlled trial to investigate the effects of 6-month integrative neuromuscular training during anti-cancer treatment on lower body muscle strength, metabolic syndrome, various measures of physical function, physical activity, days of hospitalization… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Cancer, Leukemia, Neoplasms
- What is being tested?
- Integrative neuromuscular training (INT) and motivational counseling session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesDenmark
- Study dates
- 26 Jan 2021to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All malign and benign disorders treated with chemotherapy and/or irradiation
Who cannot join
- Severe mental and/or physical disability, i.e. participants where all types of physical training and testing of physical function are contraindicated
- terminal illness
- unable to communicate in Danish
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense, 5000
About this study
Official title: Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer- a Multicenter Randomized Controlled Trial
The INTERACT study is a nation-wide, population-based randomized controlled trial to investigate the effects of 6-month integrative neuromuscular training during anti-cancer treatment on lower body muscle strength, metabolic syndrome, various measures of physical function, physical activity, days of hospitalization, health-related quality of life and health behavior in children and adolescents with cancer. The increased insight derived from this study will impact the development of pediatric exercise oncology and be of high relevance to a broad group of children and adolescents with severe chronic illness.
The study is based on the overarching hypothesis, that structured integrative neuromuscular training initiated immediately after diagnosis will be effective in preventing deficits in neuromuscular function, limit long-term cardio-metabolic morbidity and found long-standing improvements in physical activity behavior.
To maintain adherence and motivation throughout a 6-month training intervention, weekly supervision of the training is needed. For this study, it is hypothesized that a supervised exercise intervention, in addition to a motivational counseling intervention and usual care, will improve muscle strength compared with unsupervised home-based training (active controls).
Read the detailed description
Improved childhood cancer survival rates call for novel strategies to reduce acute and long-term physical complications of anti-cancer treatment.
Children with cancer have markedly impaired muscle strength, cardiorespiratory fitness, and physical function occurring few days after diagnosis - further declining because of anti-cancer treatment and physical inactivity during the treatment trajectory. Moreover, these impairments persist years after ended treatment. Further, the children become physically illiterate, which include a lack of confidence, competence and motivation to engage in physical activities. The combination of persistent physical complications and physical illiteracy predispose for metabolic- as well as musculoskeletal dysfunction that lead to severe medical conditions such as metabolic syndrome, diabetes and cardiovascular disease with reduced life-expectancy.
Studies indicate that structured exercise aimed to optimize both muscle and neuronal functions ('integrative neuromuscular training'), should be explored further to effectively counteract the impairment in physical function caused by childhood cancer and its treatment and found a more healthy lifestyle after ended treatment. This age-adjusted, strength-based exercise concept, based on games and play, is hypothesized to improve physical function in children and adolescents diagnosed with cancer.
The primary objective of this study is to investigate the effects of a 6-months integrative neuromuscular training intervention on knee extension strength in children and adolescents, ages 6-18 years, with cancer during anti-cancer treatment, compared with an active control group. Our secondary objectives are to investigate the effects of the intervention on markers of metabolic syndrome, hospitalized days, health-related quality of life, upper body muscle strength, cardiorespiratory fitness, physical function, physical activity behavior and body composition.
All outcomes, except hospitalized days, will be measured within 2 weeks of treatment initiation, 3-months after inclusion, after 6-months after inclusion, one month after ended treatment and 1 year after ended treatment.
The primary endpoint for the primary objective and secondary objectives, besides metabolic syndrome, are 6 months after treatment initiation. The primary endpoint for markers of metabolic syndrome will be 1 year after cessation of treatment
The INTERACT study is a national multicenter, two arm parallel group, randomized controlled superiority trial with 12 months follow-up after ended treatment, based in all national centers for pediatric oncology: University Hospital of Copenhagen (Rigshospitalet), Aarhus University Hospital and Odense University Hospital.
The study will include 127 children aged 6-18 years with any type of cancer that will be randomized (2:2) to either the intervention group (integrative neuromuscular training + motivational-counseling sessions + usual care) or active control group (home-based training program + motivational-counseling sessions + usual care) and stratified by sex, pubertal stage and diagnosis as 1) treatment for extracranial solid tumors and CNS-tumors; 2) treatment for hematologic malignancy 3) stem cell transplantation, within each hospital.
This intervention, integrative neuromuscular training (INT), contains a multifaceted range of developmentally appropriate activities that incorporate general and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. INT can be camouflaged as games and play or performed as structured strength and conditioning program, depending on the participant's age, motor skill level and diagnosis. The intervention is designed to enhance health- and skill-related components of physical fitness.
The integrative neuromuscular training group will in addition to usual care receive the intervention for six months.
All participants are recommended to participate in a minimum of 2 training session per week the first 7 weeks, and a minimum of three session per week from week 8-24. During the intense phase of treatment (first six months of treatment), all participants indifferent of cancer type will receive combinations of treatment requiring either hospitalization or visits to the outpatient clinic at least once per week. The participants, therefore, receives supervised training at least once per week. All other training session is conducted as home-based training. If there are weeks, without any visits to the hospital or outpatient clinic, all training session will be conducted at home. In this case, the participants will receive a phone call from the intervention physiotherapist concerning questions, exercise choice and intensity of exercises.
Parents or guardians will receive education in conducting INT at home, alongside an exercise-kit consisting of training equipment corresponding to the child's age and fitness level (fitness ropes, medicine ball, dumbbells).
The active control group is, in addition to usual care, offered a home-based training program consisting of combined aerobic, strength and stretching exercises.
Participants in both groups will receive a monthly 30-minute motivational-counseling session to adjust the intervention and training program according to the child's physical capacity and preferences. Further, the session will determine potential barriers towards performing physical exercise using the Self-efficacy for Exercise Scale.
Both groups receive standardized hospital care, usual care, including physiotherapy if needed
Sample size:
A difference of 10 % as a result of physical exercise is regarded as a clinically relevant change (1). Based on a mean 41.4 +/- 7.6 (2) and a 10% increase, an alpha level of 0.05 and power of 80%, 106 children are needed. Approximately, 60 children with cancer at the age of 6-18 years will be diagnosed pr. year at Copenhagen University Hospital, Rigshospitalet Aarhus University Hospital and Odense University Hospital. Assuming a 20 % dropout rate, a total of 2.2 years is needed to include the required number of children with cancer (n=127).
A blinded statistician will randomize participants to either intervention or active control group using a computer-generated concealed allocation procedure, to secure a proportionate stratified random sample.
Due to the nature of the intervention, neither participants, nor assessors, will be blinded to the allocation.
- Conditions
- Pediatric Cancer, Leukemia, Neoplasms, Lymphoma, Solid Tumor, CNS Tumor
- Being tested
- Integrative neuromuscular training (INT), Active control group: home-based training program, motivational counseling session
- Keywords
- Pediatric Exercise Oncology, Integrative Neuromuscular Training, Children and Adolescents, ResistanceTraining, Metabolic Syndrome, Physical Activity, Motivation
- Medical subject headings
- Neoplasms, Leukemia, Lymphoma, Central Nervous System Neoplasms, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative neuromuscular training (INT)Behavioural
Integrative neuromuscular training (INT), contains a multifaceted range of developmentally appropriate activities that incorporate general and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. INT can be camouflaged as games and play or performed as structured strength and conditioning program, depending on the participant's age, motor skill level and diagnosis. The intervention is designed to enhance health- and skill-related components of physical fitness.
Parents or guardians will receive education in conducting INT at home, alongside an exercise-kit consisting of training equipment corresponding to the child's age and fitness level (fitness ropes, medicine ball, dumbbells).
The INT group will receive usual standardized hospital care, including physiotherapy if needed.
Active control group: home-based training programBehavioural
The active control group is offered a home-based training program consisting of combined aerobic, strength and stretching exercises. Further, they will receive monthly motivational consultations, as described below, concerning the training program. The use of the home-based training program will be monitored through exercise journals.
The INT group will receive usual standardized hospital care, including physiotherapy if needed.
motivational counseling sessionBehavioural
Each child and their parents will participate in a monthly 30-minute motivational counseling session to adjust the intervention and training program according to the child's physical capacity and preferences. Further, the session will determine potential barriers towards performing physical exercise using the Self-efficacy for Exercise Scale.
The sessions are based on the principles in Self-Determination Theory that includes a spectrum of external and internal motivation factors for engaging in exercise. Each session will provide guidelines to increase the general activity levels and adjust the intervention according to the child's preferences and presence of symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Integrative neuromuscular training + motivational counseling + usual care | Experimental | General and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. Receives: Behavioral: Integrative neuromuscular training (INT); Behavioral: motivational counseling session |
| Active control group + motivational counseling + usual care | Active comparator | home-based training program Receives: Behavioral: Active control group: home-based training program; Behavioral: motivational counseling session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Measured: Within 2 weeks of treatment initiation (baseline)
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Measured: 3-months after inclusion
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Measured: 6-months after inclusion (primary endpoint)
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Measured: 1 month after ended treatment
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Measured: 1 year after ended treatment
Secondary outcomes (72)
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: within 2 weeks of treatment initiation
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: within 2 weeks of treatment initiation
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: within 2 weeks of treatment initiation
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Blood pressure (mmHg) will be measured in the morning and in the right arm with the subject in the sitting position. TMarkers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: within 2 weeks of treatment initiation
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: within 2 weeks of treatment initiation
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 month after ended treatment
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 month after ended treatment
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol(primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 month after ended treatment
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 month after ended treatment
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 month after ended treatment
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3.
Measured: 1 year after end of treatment (primary endpoint)
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 year after end of treatment (primary endpoint)
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 year after end of treatment (primary endpoint)
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 year after end of treatment (primary endpoint)
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Measured: 1 year after end of treatment (primary endpoint)
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Measured: Within 2 weeks of treatment initiation (baseline)
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Measured: 3-months after inclusion
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Measured: 6-months after inclusion (primary endpoint)
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Measured: 1 month after ended treatment
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Measured: 1 year after ended treatment
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Measured: Within 2 weeks of treatment initiation (baseline)
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Measured: 3-months after inclusion
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Measured: 6-months after inclusion (primary endpoint)
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Measured: 1 month after ended treatment
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Measured: 1 year after ended treatment
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Measured: Within 2 weeks of treatment initiation (baseline)
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Measured: 3-months after inclusion
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Measured: 6-months after inclusion (primary endpoint)
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Measured: 1 month after ended treatment
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Measured: 1 year after ended treatment
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Measured: Within 2 weeks of treatment initiation (baseline)
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Measured: 3-months after inclusion
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Measured: 6-months after inclusion (primary endpoint)
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Measured: 3-months after inclusion
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Measured: 1 month after ended treatment
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Measured: 1 year after ended treatment
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Measured: Within 2 weeks of treatment initiation (baseline)
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Measured: 6-months after inclusion (primary endpoint)
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Measured: 1 month after ended treatment
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Measured: 1 year after ended treatment
Hospitalized days
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Measured: measured 6 months after inclusion (primary endpoint)
Hospitalized days
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Measured: 1month after ended treatment
Hospitalized days
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Measured: 1 year after ended treatment
Body composition: Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: within 2 weeks of treatment initiation
Body composition: Bone Mineral Content
Bone Mineral content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: within 2 weeks of treatment initiation
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: within 2 weeks of treatment initiation
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: within 2 weeks of treatment initiation
Body composition: Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 6 months after inclusion (before a treatment block)
Body composition: Bone Mineral Content
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 6 months after inclusion (before a treatment block)
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 6 months after inclusion (before a treatment block)
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 6 months after inclusion (before a treatment block)
Body composition: Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 1 month after ended treatment.
Body composition: Bone Mineral Content
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 1 month after ended treatment.
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 1 month after ended treatment.
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 1 month after ended treatment.
Body composition: Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 1 year after end of treatment (primary endpoint).
Body composition: Bone Mineral Content
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 1 year after end of treatment (primary endpoint).
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 1 year after end of treatment (primary endpoint).
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Measured: 1 year after end of treatment (primary endpoint).
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Measured: Within 2 weeks of treatment initiation
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Measured: 6-months after inclusion.
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Measured: 1 month after ended treatment
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Measured: 1 year after ended treatment
Prevalence of metabolic syndrome
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Measured: within 2 weeks of treatment initiation.
Prevalence of metabolic syndrome
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Measured: 6 months after inclusion (before a treatment block)
Prevalence of metabolic syndrome
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Measured: 1 month after ended treatment.
Prevalence of metabolic syndrome
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Measured: 1 year after end of treatment (primary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start26 Jan 2021
- Primary completionOct 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Hanne Baekgaard Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Hanne B. Larsen, As. Prof, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706676
- Sponsor's protocol ID
- INTERACT-2020
- Other IDs
- 2019-5954, E-22597-01, 20-B-0409
- Acronym
- INTERACT
- Status last verified
- Jun 2025
- First submitted
- 5 Jan 2021
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544.
PubMed 24229362Fiuza-Luces C, Padilla JR, Soares-Miranda L, Santana-Sosa E, Quiroga JV, Santos-Lozano A, Pareja-Galeano H, Sanchis-Gomar F, Lorenzo-Gonzalez R, Verde Z, Lopez-Mojares LM, Lassaletta A, Fleck SJ, Perez M, Perez-Martinez A, Lucia A. Exercise Intervention in Pediatric Patients with Solid Tumors: The Physical Activity in Pediatric Cancer Trial. Med Sci Sports Exerc. 2017 Feb;49(2):223-230. doi: 10.1249/MSS.0000000000001094.
PubMed 27631396Zimmet P, Alberti KG, Kaufman F, Tajima N, Silink M, Arslanian S, Wong G, Bennett P, Shaw J, Caprio S; IDF Consensus Group. The metabolic syndrome in children and adolescents - an IDF consensus report. Pediatr Diabetes. 2007 Oct;8(5):299-306. doi: 10.1111/j.1399-5448.2007.00271.x. No abstract available.
PubMed 17850473Schmidt-Andersen P, Pouplier A, Faigenbaum AD, Beth CK, Olsen CC, Lykkedegn S, Hasle H, Muller K, Larsen HB, Fridh M, Christensen J. Evaluating Feasibility of an Exercise Intervention Including Physical Assessment During the First 6 Months of Cancer Treatment in Children and Adolescents in a Randomized Controlled Trial. Pediatr Blood Cancer. 2025 Mar;72(3):e31498. doi: 10.1002/pbc.31498. Epub 2025 Jan 2.
PubMed 39745099Schmidt-Andersen P, Fridh MK, Muller KG, Anna Pouplier, Hjalgrim LL, Faigenbaum AD, Schmiegelow K, Hasle H, Lykkedegn S, Zhang H, Christensen J, Larsen HB. Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer (INTERACT): Study Protocol for a Multicenter, Two-Arm Parallel-Group Randomized Controlled Superiority Trial. Front Pediatr. 2022 Mar 14;10:833850. doi: 10.3389/fped.2022.833850. eCollection 2022.
PubMed 35359909
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer- a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04706676
- Acronym / sponsor ID
- INTERACT / INTERACT-2020
- Conditions
- Pediatric Cancer, Leukemia, Neoplasms, Lymphoma, Solid Tumor, CNS Tumor
- Keywords
- Pediatric Exercise Oncology, Integrative Neuromuscular Training, Children and Adolescents, ResistanceTraining, Metabolic Syndrome, Physical Activity, Motivation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The INTERACT study is a nation-wide, population-based randomized controlled trial to investigate the effects of 6-month integrative neuromuscular training during anti-cancer treatment on lower body muscle strength, metabolic syndrome, various measures of physical function, physical activity, days of hospitalization, health-related quality of life and health behavior in children and adolescents with cancer. The increased insight derived from this study will impact the development of pediatric exercise oncology and be of high relevance to a broad group of children and adolescents with severe chronic illness.
The study is based on the overarching hypothesis, that structured integrative neuromuscular training initiated immediately after diagnosis will be effective in preventing deficits in neuromuscular function, limit long-term cardio-metabolic morbidity and found long-standing improvements in physical activity behavior.
To maintain adherence and motivation throughout a 6-month training intervention, weekly supervision of the training is needed. For this study, it is hypothesized that a supervised exercise intervention, in addition to a motivational counseling intervention and usual care, will improve muscle strength compared with unsupervised home-based training (active controls).
Detailed description
Improved childhood cancer survival rates call for novel strategies to reduce acute and long-term physical complications of anti-cancer treatment.
Children with cancer have markedly impaired muscle strength, cardiorespiratory fitness, and physical function occurring few days after diagnosis - further declining because of anti-cancer treatment and physical inactivity during the treatment trajectory. Moreover, these impairments persist years after ended treatment. Further, the children become physically illiterate, which include a lack of confidence, competence and motivation to engage in physical activities. The combination of persistent physical complications and physical illiteracy predispose for metabolic- as well as musculoskeletal dysfunction that lead to severe medical conditions such as metabolic syndrome, diabetes and cardiovascular disease with reduced life-expectancy.
Studies indicate that structured exercise aimed to optimize both muscle and neuronal functions ('integrative neuromuscular training'), should be explored further to effectively counteract the impairment in physical function caused by childhood cancer and its treatment and found a more healthy lifestyle after ended treatment. This age-adjusted, strength-based exercise concept, based on games and play, is hypothesized to improve physical function in children and adolescents diagnosed with cancer.
The primary objective of this study is to investigate the effects of a 6-months integrative neuromuscular training intervention on knee extension strength in children and adolescents, ages 6-18 years, with cancer during anti-cancer treatment, compared with an active control group. Our secondary objectives are to investigate the effects of the intervention on markers of metabolic syndrome, hospitalized days, health-related quality of life, upper body muscle strength, cardiorespiratory fitness, physical function, physical activity behavior and body composition.
All outcomes, except hospitalized days, will be measured within 2 weeks of treatment initiation, 3-months after inclusion, after 6-months after inclusion, one month after ended treatment and 1 year after ended treatment.
The primary endpoint for the primary objective and secondary objectives, besides metabolic syndrome, are 6 months after treatment initiation. The primary endpoint for markers of metabolic syndrome will be 1 year after cessation of treatment
The INTERACT study is a national multicenter, two arm parallel group, randomized controlled superiority trial with 12 months follow-up after ended treatment, based in all national centers for pediatric oncology: University Hospital of Copenhagen (Rigshospitalet), Aarhus University Hospital and Odense University Hospital.
The study will include 127 children aged 6-18 years with any type of cancer that will be randomized (2:2) to either the intervention group (integrative neuromuscular training + motivational-counseling sessions + usual care) or active control group (home-based training program + motivational-counseling sessions + usual care) and stratified by sex, pubertal stage and diagnosis as 1) treatment for extracranial solid tumors and CNS-tumors; 2) treatment for hematologic malignancy 3) stem cell transplantation, within each hospital.
This intervention, integrative neuromuscular training (INT), contains a multifaceted range of developmentally appropriate activities that incorporate general and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. INT can be camouflaged as games and play or performed as structured strength and conditioning program, depending on the participant's age, motor skill level and diagnosis. The intervention is designed to enhance health- and skill-related components of physical fitness.
The integrative neuromuscular training group will in addition to usual care receive the intervention for six months.
All participants are recommended to participate in a minimum of 2 training session per week the first 7 weeks, and a minimum of three session per week from week 8-24. During the intense phase of treatment (first six months of treatment), all participants indifferent of cancer type will receive combinations of treatment requiring either hospitalization or visits to the outpatient clinic at least once per week. The participants, therefore, receives supervised training at least once per week. All other training session is conducted as home-based training. If there are weeks, without any visits to the hospital or outpatient clinic, all training session will be conducted at home. In this case, the participants will receive a phone call from the intervention physiotherapist concerning questions, exercise choice and intensity of exercises.
Parents or guardians will receive education in conducting INT at home, alongside an exercise-kit consisting of training equipment corresponding to the child's age and fitness level (fitness ropes, medicine ball, dumbbells).
The active control group is, in addition to usual care, offered a home-based training program consisting of combined aerobic, strength and stretching exercises.
Participants in both groups will receive a monthly 30-minute motivational-counseling session to adjust the intervention and training program according to the child's physical capacity and preferences. Further, the session will determine potential barriers towards performing physical exercise using the Self-efficacy for Exercise Scale.
Both groups receive standardized hospital care, usual care, including physiotherapy if needed
Sample size:
A difference of 10 % as a result of physical exercise is regarded as a clinically relevant change (1). Based on a mean 41.4 +/- 7.6 (2) and a 10% increase, an alpha level of 0.05 and power of 80%, 106 children are needed. Approximately, 60 children with cancer at the age of 6-18 years will be diagnosed pr. year at Copenhagen University Hospital, Rigshospitalet Aarhus University Hospital and Odense University Hospital. Assuming a 20 % dropout rate, a total of 2.2 years is needed to include the required number of children with cancer (n=127).
A blinded statistician will randomize participants to either intervention or active control group using a computer-generated concealed allocation procedure, to secure a proportionate stratified random sample.
Due to the nature of the intervention, neither participants, nor assessors, will be blinded to the allocation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative neuromuscular training + motivational counseling + usual care | Experimental | Behavioral: Integrative neuromuscular training (INT), Behavioral: motivational counseling sessionGeneral and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. |
| Active control group + motivational counseling + usual care | Active comparator | Behavioral: Active control group: home-based training program, Behavioral: motivational counseling sessionhome-based training program |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All malign and benign disorders treated with chemotherapy and/or irradiation
Key exclusion criteria (3 listed)
- Severe mental and/or physical disability, i.e. participants where all types of physical training and testing of physical function are contraindicated
- terminal illness
- unable to communicate in Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative neuromuscular training (INT)Integrative neuromuscular training (INT), contains a multifaceted range of developmentally appropriate activities that incorporate general and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. INT can be camouflaged as games and play or performed as structured strength and conditioning program, depending on the participant's age, motor skill level and diagnosis. The intervention is designed to enhance health- and skill-related components of physical fitness. Parents or guardians will receive education in conducting INT at home, alongside an exercise-kit consisting of training equipment corresponding to the child's age and fitness level (fitness ropes, medicine ball, dumbbells). The INT group will receive usual standardized hospital care, including physiotherapy if needed. | Behavioural | Integrative neuromuscular training + motivational counseling + usual care |
| Active control group: home-based training programThe active control group is offered a home-based training program consisting of combined aerobic, strength and stretching exercises. Further, they will receive monthly motivational consultations, as described below, concerning the training program. The use of the home-based training program will be monitored through exercise journals. The INT group will receive usual standardized hospital care, including physiotherapy if needed. | Behavioural | Active control group + motivational counseling + usual care |
| motivational counseling sessionEach child and their parents will participate in a monthly 30-minute motivational counseling session to adjust the intervention and training program according to the child's physical capacity and preferences. Further, the session will determine potential barriers towards performing physical exercise using the Self-efficacy for Exercise Scale. The sessions are based on the principles in Self-Determination Theory that includes a spectrum of external and internal motivation factors for engaging in exercise. Each session will provide guidelines to increase the general activity levels and adjust the intervention according to the child's preferences and presence of symptoms. | Behavioural | Active control group + motivational counseling + usual care, Integrative neuromuscular training + motivational counseling + usual care |
Primary outcome
Lower extremity isometric knee extension strength
Time frame: Within 2 weeks of treatment initiation (baseline)
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
Time frame: 3-months after inclusion
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
Time frame: 6-months after inclusion (primary endpoint)
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
Time frame: 1 month after ended treatment
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
Time frame: 1 year after ended treatment
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany). The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
72 secondary outcomes
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Time frame: within 2 weeks of treatment initiation
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Time frame: within 2 weeks of treatment initiation
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Time frame: within 2 weeks of treatment initiation
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Time frame: within 2 weeks of treatment initiation
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Time frame: within 2 weeks of treatment initiation
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Time frame: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Time frame: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Time frame: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Time frame: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Time frame: 6 months after inclusion (before a treatment block)
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Time frame: 1 month after ended treatment
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Time frame: 1 month after ended treatment
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol(primary secondary outcome)
Time frame: 1 month after ended treatment
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Time frame: 1 month after ended treatment
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Time frame: 1 month after ended treatment
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Time frame: 1 year after end of treatment (primary endpoint)
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Time frame: 1 year after end of treatment (primary endpoint)
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Time frame: 1 year after end of treatment (primary endpoint)
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Time frame: 1 year after end of treatment (primary endpoint)
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Time frame: 1 year after end of treatment (primary endpoint)
Isometric Bench Press
Time frame: Within 2 weeks of treatment initiation (baseline)
Isometric Bench Press
Time frame: 3-months after inclusion
Isometric Bench Press
Time frame: 6-months after inclusion (primary endpoint)
Isometric Bench Press
Time frame: 1 month after ended treatment
Isometric Bench Press
Time frame: 1 year after ended treatment
Hand Grip strength
Time frame: Within 2 weeks of treatment initiation (baseline)
Hand Grip strength
Time frame: 3-months after inclusion
Hand Grip strength
Time frame: 6-months after inclusion (primary endpoint)
Hand Grip strength
Time frame: 1 month after ended treatment
Hand Grip strength
Time frame: 1 year after ended treatment
Six Minutes Walk Test
Time frame: Within 2 weeks of treatment initiation (baseline)
Six Minutes Walk Test
Time frame: 3-months after inclusion
Six Minutes Walk Test
Time frame: 6-months after inclusion (primary endpoint)
Six Minutes Walk Test
Time frame: 1 month after ended treatment
Six Minutes Walk Test
Time frame: 1 year after ended treatment
Thirty Seconds and One-Minute Sit-to-stand
Time frame: Within 2 weeks of treatment initiation (baseline)
Thirty Seconds and One-Minute Sit-to-stand
Time frame: 3-months after inclusion
Thirty Seconds and One-Minute Sit-to-stand
Time frame: 6-months after inclusion (primary endpoint)
The timed Up-and-Go Test:
Time frame: 3-months after inclusion
Thirty Seconds and One-Minute Sit-to-stand
Time frame: 1 month after ended treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 24229362Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544.
- Background: PubMed 27631396Fiuza-Luces C, Padilla JR, Soares-Miranda L, Santana-Sosa E, Quiroga JV, Santos-Lozano A, Pareja-Galeano H, Sanchis-Gomar F, Lorenzo-Gonzalez R, Verde Z, Lopez-Mojares LM, Lassaletta A, Fleck SJ, Perez M, Perez-Martinez A, Lucia A. Exercise Intervention in Pediatric Patients with Solid Tumors: The Physical Activity in Pediatric Cancer Trial. Med Sci Sports Exerc. 2017 Feb;49(2):223-230. doi: 10.1249/MSS.0000000000001094.
- Background: PubMed 17850473Zimmet P, Alberti KG, Kaufman F, Tajima N, Silink M, Arslanian S, Wong G, Bennett P, Shaw J, Caprio S; IDF Consensus Group. The metabolic syndrome in children and adolescents - an IDF consensus report. Pediatr Diabetes. 2007 Oct;8(5):299-306. doi: 10.1111/j.1399-5448.2007.00271.x. No abstract available.
- Derived from this study: PubMed 39745099Schmidt-Andersen P, Pouplier A, Faigenbaum AD, Beth CK, Olsen CC, Lykkedegn S, Hasle H, Muller K, Larsen HB, Fridh M, Christensen J. Evaluating Feasibility of an Exercise Intervention Including Physical Assessment During the First 6 Months of Cancer Treatment in Children and Adolescents in a Randomized Controlled Trial. Pediatr Blood Cancer. 2025 Mar;72(3):e31498. doi: 10.1002/pbc.31498. Epub 2025 Jan 2.
- Derived from this study: PubMed 35359909Schmidt-Andersen P, Fridh MK, Muller KG, Anna Pouplier, Hjalgrim LL, Faigenbaum AD, Schmiegelow K, Hasle H, Lykkedegn S, Zhang H, Christensen J, Larsen HB. Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer (INTERACT): Study Protocol for a Multicenter, Two-Arm Parallel-Group Randomized Controlled Superiority Trial. Front Pediatr. 2022 Mar 14;10:833850. doi: 10.3389/fped.2022.833850. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne B. Larsen, As. Prof principal investigator
Copenhagen University Hospital, Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative neuromuscular training (INT) and motivational counseling session in people with Pediatric Cancer and Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity isometric knee extension strength (time frame: Within 2 weeks of treatment initiation (baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706676, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.