Hematopoietic System--CancerHenkōNCT06300515
Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation
A study testing Intervention Group in people with Hematopoietic System--Cancer, run by Alejandro Lucia at 1 site in Spain.
Trial summary
Thanks to medical advances, survival rates >5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Hematopoietic System--Cancer
- What is being tested?
- Intervention Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 31 Dec 2026
- 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 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 4 and 21 years.
- Undergoing hematopoietic stem cell transplantation (HSCT) for cancer diagnosis in complete remission or without remission, in 3 recruiting Hospitals in Madrid
- Undergoing treatment and follow-up in the same hospital.
- Speaking Spanish.
- Showing adequate baseline health status (Karnofsky >50, Eastern Cooperative Oncology Group scale score <2).
- Providing signed informed consent.
Who cannot join
- Not being able to participate in the trial according to protocol.
- Comorbidity or acute condition not associated with the diagnosis and that contraindicates the practice of physical exercise, such as severe deficiencies in the locomotor, neurological, cardiovascular and pulmonary systems.
- Serious or chronic medical or psychiatric condition that may increase the risk associated with participation in the trial or that may interfere with the interpretation of the results and, in the opinion of the investigator in discussion with the team, makes having such condition inappropriate for entry to this study; inability to understand the study requirements.
- Not being able to attend hospital visits to perform assessment tests, nor participate in the physical exercise and health counseling program as stipulated in the protocol.
- Inability to understand the requirements of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital 12 de Octubre
Madrid, Madrid, 28041
About this study
Official title: Exercise Intervention in Childhood and Adolescence Hematopoietic Stem Cell Transplantation: The Henkō Trial
Thanks to medical advances, survival rates >5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.
Read the detailed description
Hematopoietic stem cell transplantation (HSCT), which is used to treat high-risk malignancies, as well as some other conditions or even autoimmune processes, consists of several phases: mobilization and subsequent collection of hematopoietic stem cells from the patient (autologous HSCT) or from a donor (allogeneic HSCT); pre-HSCT conditioning; infusion of patient/donor cells; establishment of a new immune and hematopoietic system in the recipient; and prophylaxis/treatment of possible adverse effects. Since the first successful allogeneic transplant was performed in 1968, thanks to the advances experienced in conditioning regimens, as well as in donor-recipient histocompatibility testing, in patient care and in the management of graft versus host disease (GvHD), together with the increase in the number of donors, the expectations of children and adolescents who receive HSCT have improved, achieving long-term survival rates (>5 years) >70%. Yet survivors are at high risk of suffering side effects and toxicities derived from the HSCT itself and/or the underlying disease, with subsequent functional decline. In addition, they show a higher risk of rehospitalization than pediatric cancer survivors who did not receive HSCT and tend to develop chronic pathologies (especially cardiometabolic conditions and frailty) at earlier stages of adulthood than the general population.
The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on the following outcomes assessed at 3 time points [start of hospitalization for HSCT (i.e., baseline), and 8 weeks and 3 months after hospital discharge, respectively]: muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). We will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.
- Conditions
- Hematopoietic System--Cancer
- Being tested
- Control Group (Active Comparator), Intervention Group
- Keywords
- exercise, pediatric cancer, health counseling
- Medical subject headings
- Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group (Active Comparator)Behavioural
Also called Health Counseling only
During the intervention phase (hospitalization for HSCT and subsequent 8-week outpatient phase following discharge), the control group will participate in a Health Counseling Program (1 time/week) on aspects related to a healthy lifestyle such as reducing sedentary lifestyle, acquiring healthy nutritional habits, the importance sleep, screen use, and how to address barriers related to clinical status. We will adapt the program to the needs and timing of the patient's treatment, providing the content in one session/week orally (e.g. using presentations) and in writing (e.g. through brochures).
Intervention GroupBehavioural
Also called Health Counseling + Exercise
Same as Control Group + exercise program as described below:
Same as Control Group + exercise program as described below:
Hospital ward (during HSCT); and Hospital Gym or online (patients' home) during the outpatient phase. Frequency: 3-5 days/week. Session duration: 15 to 65 minutes. Muscle strength training (30 minutes): large muscle group exercises (upper/lower limb + trunk exercises) performed as a circuit using body weight or against resistance (against gravity and with body weight, elastic bands, dumbbells, weighted vests, machines), with a wide range of joint mobility and at submaximal/maximum voluntary speed. Aerobic training (10-20 minutes): bicycling, crank-ergometry, circuit-style exercises, and games. Inspiratory muscle training will also be performed (5 min daily, using a specific device that creates resistance against inspiration).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | During the intervention phase (hospitalization for hematopoietic stem cell transplantation (HSCT) and subsequent 8-week outpatient phase following discharge), the control group will participate in a Health Counseling Program (1 time/week) on aspects related to a healthy lifestyle such as reducing sedentary lifestyle, acquiring healthy nutritional habits, the importance sleep, screen use, and how to address barriers related to clinical status. We will adapt the program to the needs and timing of the patient's treatment, providing the content in one session/week orally (e.g. using presentations) and in writing (e.g. through brochures). Receives: Behavioral: Control Group (Active Comparator) |
| Exercise | Experimental | During the intervention phase (hospitalization for hematopoietic stem cell transplantation (HSCT) and subsequent 8-week outpatient phase following discharge), the intervention group will participate in exactly the same Health Counseling Program as the Control group. Additionally, this group will perform an exercise program combining aerobic and muscle strength exercises Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in unilateral knee-extension muscle strength (from baseline to end of treatment)
Unilateral knee-extension muscle strength will be assessed using a 5-RM test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Secondary outcomes (158)
Change in unilateral knee-extension muscle strength (from baseline to follow-up)
Unilateral knee-extension muscle strength will be assessed using a 5-RM test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to end of treatment)
Unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) will be assessed using a portable digital dynamometer tissue
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to follow-up)
Unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) will be assessed using a portable digital dynamometer tissue
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to end of treatment)
Unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) will be assessed using a portable digital dynamometer tissue
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to follow-up)
Unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) will be assessed using a portable digital dynamometer tissue
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in handgrip strength (from baseline to end of treatment)
Handgrip strength will be assessed using a handheld digital Smedley dynamometer (TKK 5401, Takei Scientific Instruments Co., Ltd., Niigata, Japan)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in handgrip strength (from baseline to follow-up)
Handgrip strength will be assessed using a handheld digital Smedley dynamometer (TKK 5401, Takei Scientific Instruments Co., Ltd., Niigata, Japan)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in maximum inspiratory muscle strength (from baseline to end of treatment)
Maximum inspiratory muscle strength will be assessed using a mouth pressure meter (CareFusion MicroRPM Respiratory Pressure Meter; Kent, UK)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in maximum inspiratory muscle strength (from baseline to follow-up)
Maximum inspiratory muscle strength will be assessed using a mouth pressure meter (CareFusion MicroRPM Respiratory Pressure Meter; Kent, UK)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in VO2 (mL·kg-1·min-1) at peak (from baseline to end of treatment)
VO2 (mL·kg-1·min-1) at peak will be assessed using a ramp-like bicycle ergometer
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in VO2 (mL·kg-1·min-1) at peak (from baseline to follow-up)
VO2 (mL·kg-1·min-1) at peak will be assessed using a ramp-like bicycle ergometer
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in VO2 (mL·kg-1·min-1) at the ventilatory threshold (from baseline to end of treatment)
VO2 (mL·kg-1·min-1) at the ventilatory threshold will be assessed using a ramp-like bicycle ergometer
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in VO2 (mL·kg-1·min-1) at the ventilatory threshold (from baseline to follow-up)
VO2 (mL·kg-1·min-1) at the ventilatory threshold will be assessed using a ramp-like bicycle ergometer
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in power output (watts) at peak (from baseline to end of treatment)
Power output (watts) at peak will be assessed using a ramp-like bicycle ergometer
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in power output (watts) at peak (from baseline to follow-up)
Power output (watts) at peak will be assessed using a ramp-like bicycle ergometer
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in power output (watts) at the ventilatory threshold (from baseline to end of treatment)
Power output (watts) at the ventilatory threshold will be assessed using a ramp-like bicycle ergometer
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in power output (watts) at the ventilatory threshold (from baseline to follow-up)
Power output (watts) at the ventilatory threshold will be assessed using a ramp-like bicycle ergometer
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in walking distance covered (m) (from baseline to end of treatment)
Walking distance will be assessed using the 6-minute walking test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in walking distance covered (m) (from baseline to follow-up)
Walking distance will be assessed using the 6-minute walking test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in heart rate recovery (beats/min) (from baseline to end of treatment)
Heart rate recovery will be assessed using a heart rate monitor after completing the 3-minute step test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in heart rate recovery (beats/min) (from baseline to follow-up)
Heart rate recovery will be assessed using a heart rate monitor after completing the 3-minute step test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in range of motion of the ankle (from baseline to end of treatment)
Range of motion of the ankle will be assessed using a goniometer (Baseline Evaluation Instruments, Fabrication Enterprises Inc.; Elmsford, NY)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in range of motion of the ankle (from baseline to follow-up)
Range of motion of the ankle will be assessed using a goniometer (Baseline Evaluation Instruments, Fabrication Enterprises Inc.; Elmsford, NY)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in physical activity (from baseline to end of treatment)
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in physical activity (from baseline to follow-up)
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in body mass index (from baseline to end of treatment)
Body mass index will be calculated dividing body weight in kilograms by the square of the height in meters (kg/m2)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in body mass index (from baseline to follow-up)
Body mass index will be calculated dividing body weight in kilograms by the square of the height in meters (kg/m2)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in waist-to-hip ratio (from baseline to end of treatment)
Waist-to-hip ratio will be calculated dividing waist by hip circumference (Gulick II Tape Measure, Country Technology, Inc.; Gays Mills, WI) using the same units
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in waist-to-hip ratio (from baseline to follow-up)
Waist-to-hip ratio will be calculated dividing waist by hip circumference (Gulick II Tape Measure, Country Technology, Inc.; Gays Mills, WI) using the same units
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in arm circumference (from baseline to end of treatment)
Arm circumference will be assessed under relaxed and contracted conditions (Gulick II Tape Measure, Country Technology, Inc.; Gays Mills, WI)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in arm circumference (from baseline to follow-up)
Arm circumference will be assessed under relaxed and contracted conditions (Gulick II Tape Measure, Country Technology, Inc.; Gays Mills, WI)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in lean mass (from baseline to end of treatment)
Lean mass will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in lean mass (from baseline to follow-up)
Lean mass will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in fat mass (from baseline to end of treatment)
Fat mass will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in fat mass (from baseline to follow-up)
Fat mass will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in visceral fat (from baseline to end of treatment)
Visceral fat will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in visceral fat (from baseline to follow-up)
Visceral fat will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in fat percentage (from baseline to end of treatment)
Fat percentage will be assessed using triceps skinfold (Harpenden caliper, Crymych, United Kingdom)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in fat percentage (from baseline to follow-up)
Fat percentage will be assessed using triceps skinfold (Harpenden caliper, Crymych, United Kingdom)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in bone mineral density of the total body (less head) (from baseline to end of treatment)
Bone mineral density of the total body (less head) will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in bone mineral density of the total body (less head) (from baseline to follow-up)
Bone mineral density of the total body (less head) will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in bone mineral density of the femoral neck (from baseline to end of treatment)
Bone mineral density of the femoral neck will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in bone mineral density of the femoral neck (from baseline to follow-up)
Bone mineral density of the femoral neck will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in phase angle (º) (from baseline to end of treatment)
Phase angle (º) will be assessed using multi-frequency bioelectrical impedance analysis (BodyComposition software, version 9.0.21212-29; Dietosystem, Italy), and it is calculated as the arctangent of reactance to resistance, following standardized measurement procedures.Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in phase angle (º) (from baseline to follow-up)
Phase angle (º) will be assessed using multi-frequency bioelectrical impedance analysis (BodyComposition software, version 9.0.21212-29; Dietosystem, Italy), and it is calculated as the arctangent of reactance to resistance, following standardized measurement procedures.Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in adherence to Mediterranean diet (from baseline to end of treatment)
Adherence to Mediterranean diet will be assessed using the Mediterranean Diet Quality Index for children and adolescents (KIDMED) questionnaire
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in adherence to Mediterranean diet (from baseline to follow-up)
Adherence to Mediterranean diet will be assessed using the Mediterranean Diet Quality Index for children and adolescents (KIDMED) questionnaire
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in health-related quality of life (from baseline to end of treatment)
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 (Patients and Tutor's version, Cancer Module)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in health-related quality of life (from baseline to follow-up)
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 (Patients and Tutor's version, Cancer Module)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in cancer-related fatigue (from baseline to end of treatment)
Cancer-related fatigue will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 (Patients and Tutor's version, Multidimensional Fatigue Scale)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in cancer-related fatigue (from baseline to follow-up)
Cancer-related fatigue will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 (Patients and Tutor's version, Multidimensional Fatigue Scale)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in survival (from baseline to end of treatment)
Survival will be assessed from diagnosis to the end of the study or death using medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in survival (from baseline to follow-up)
Survival will be assessed from diagnosis to the end of the study or death using medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in treatment tolerability (from baseline to end of treatment)
Treatment tolerability will be assessed as the number of days of treatment interruption/delay and hospitalization length (additional/prolonged hospitalization during treatment) using medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in toxicity grades (from baseline to end of treatment)
Toxicity grade will be assessed using the formula from Langlais et al (2022)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in toxicity grades (from baseline to follow-up)
Toxicity grade will be assessed using the formula from Langlais et al (2022)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in left-ventricular (LV) mass (from baseline to end of treatment)
LV mass will be assessed using 2-D guided M-mode imaging
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in left-ventricular (LV) mass (from baseline to follow-up)
LV mass will be assessed using 2-D guided M-mode imaging
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in interventricular septum thickness (IVS) (from baseline to end of treatment)
IVS will be assessed using 2-D guided M-mode imaging
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in interventricular septum thickness (IVS) (from baseline to follow-up)
IVS will be assessed using 2-D guided M-mode imaging
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in LV end-diastolic volume (LVEDV) (from baseline to end of treatment)
LVEDV will be assessed using 2-D guided M-mode imaging
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in LV end-diastolic volume (LVEDV) (from baseline to follow-up)
LVEDV will be assessed using 2-D guided M-mode imaging
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in LV posterior wall thickness (LVPW) (from baseline to end of treatment)
LVPW will be assessed using 2-D guided M-mode imaging
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in LV posterior wall thickness (LVPW) (from baseline to follow-up)
LVPW will be assessed using 2-D guided M-mode imaging
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in relative wall thickness (RWT) (from baseline to end of treatment)
RWT will be assessed using the following formula: RWT = (IVS + LVPW)/LVEDV
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in relative wall thickness (RWT) (from baseline to follow-up)
RWT will be assessed using the following formula: RWT = (IVS + LVPW)/LVEDV
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in LV hypertrophy (from baseline to end of treatment)
LV hypertrophy will be assessed using the age-specific >95th percentile for LV mass indexed by height (in g·m-2.7)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in LV hypertrophy (from baseline to follow-up)
LV hypertrophy will be assessed using the age-specific >95th percentile for LV mass indexed by height (in g·m-2.7)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in LV ejection fraction (from baseline to end of treatment)
LV ejection fraction will be assessed using color tissue Doppler echocardiography
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in LV ejection fraction (from baseline to follow-up)
LV ejection fraction will be assessed using color tissue Doppler echocardiography
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in LV fractional shortening (from baseline to end of treatment)
LV fractional shortening will be assessed using color tissue Doppler echocardiography
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in LV fractional shortening (from baseline to follow-up)
LV fractional shortening will be assessed using color tissue Doppler echocardiography
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in LV global longitudinal strain (from baseline to end of treatment)
LV global longitudinal strain will be assessed using 2D-speckle tracking echocardiography
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in LV global longitudinal strain (from baseline to follow-up)
LV global longitudinal strain will be assessed using 2D-speckle tracking echocardiography
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in NT-proBNP (from baseline to end of treatment)
NT-proBNP will be determined with the relevant immunoassay kits on an automated biochemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in NT-proBNP (from baseline to follow-up)
NT-proBNP will be determined with the relevant immunoassay kits on an automated biochemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in high-sensitivity cardiac troponin-I (from baseline to end of treatment)
High-sensitivity cardiac troponin-I will be determined with the relevant immunoassay kits on an automated biochemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in high-sensitivity cardiac troponin-I (from baseline to follow-up)
High-sensitivity cardiac troponin-I will be determined with the relevant immunoassay kits on an automated biochemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in high-sensitivity C-reactive protein levels (from baseline to end of treatment)
High-sensitivity C-reactive protein levels will be assessed using a chemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in high-sensitivity C-reactive protein levels (from baseline to follow-up)
High-sensitivity C-reactive protein levels will be assessed using a chemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in total cholesterol (from baseline to end of treatment)
Fasting blood samples will be used to assess total cholesterol
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in total cholesterol (from baseline to follow-up)
Fasting blood samples will be used to assess total cholesterol
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in high-density lipoprotein cholesterol (from baseline to end of treatment)
Fasting blood samples will be used to assess high-density lipoprotein cholesterol
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in high-density lipoprotein cholesterol (from baseline to follow-up)
Fasting blood samples will be used to assess high-density lipoprotein cholesterol
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in low-density lipoprotein cholesterol (from baseline to end of treatment)
Fasting blood samples will be used to assess low-density lipoprotein cholesterol
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in low-density lipoprotein cholesterol (from baseline to follow-up)
Fasting blood samples will be used to assess low-density lipoprotein cholesterol
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in triglycerides (from baseline to end of treatment)
Fasting blood samples will be used to assess triglycerides
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in triglycerides (from baseline to follow-up)
Fasting blood samples will be used to assess triglycerides
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in apolipoprotein B (from baseline to end of treatment)
Fasting blood samples will be used to assess apolipoprotein B
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in apolipoprotein B (from baseline to follow-up)
Fasting blood samples will be used to assess apolipoprotein B
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in fasting glycaemia (from baseline to end of treatment)
Fasting blood samples will be used to assess glycaemia
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in fasting glycaemia (from baseline to follow-up)
Fasting blood samples will be used to assess glycaemia
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in glycated hemoglobin (from baseline to end of treatment)
Fasting blood samples will be used to assess glycated hemoglobin
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in glycated hemoglobin (from baseline to follow-up)
Fasting blood samples will be used to assess glycated hemoglobin
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in insulin (from baseline to end of treatment)
Fasting blood samples will be used to assess insulin
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in insulin (from baseline to follow-up)
Fasting blood samples will be used to assess insulin
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in homeostasis model assessment-insulin resistance index (from baseline to end of treatment)
Fasting blood samples will be used to assess glucose and insulin, and homeostasis model assessment-insulin resistance index will be computed
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in homeostasis model assessment-insulin resistance index (from baseline to follow-up)
Fasting blood samples will be used to assess glucose and insulin, and homeostasis model assessment-insulin resistance index will be computed
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in total leukocyte and monocyte count (from baseline to end of treatment)
Total leukocyte and monocyte count will be assessed using a hematology analyzer (Advia 120 Hematology System, Bayer Corporation; Tarrytown, NY)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in total leukocyte and monocyte count (from baseline to follow-up)
Total leukocyte and monocyte count will be assessed using a hematology analyzer (Advia 120 Hematology System, Bayer Corporation; Tarrytown, NY)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in main lymphocyte subpopulations (%) (from baseline to end of treatment)
Main lymphocyte subpopulations will be assessed on fresh blood samples using a multiparametric flow cytometer (FACSCantoTM II, Becton Dickinson and Company BD Biosciences; San Jose, CA) together with BD FACSDivaTM software version 8 (Becton Dickinson and Company BD Biosciences)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in main lymphocyte subpopulations (%) (from baseline to follow-up)
Main lymphocyte subpopulations will be assessed on fresh blood samples using a multiparametric flow cytometer (FACSCantoTM II, Becton Dickinson and Company BD Biosciences; San Jose, CA) together with BD FACSDivaTM software version 8 (Becton Dickinson and Company BD Biosciences)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in gut microbiome diversity (from baseline to end of treatment)
DNA sequencing to determine gut microbiome diversity (i.e., alpha and beta)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in gut microbiome diversity (from baseline to follow-up)
DNA sequencing to determine gut microbiome diversity (i.e., alpha and beta)
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in specific bacteria abundance (from baseline to end of treatment)
DNA sequencing to determine specific bacteria abundance
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in specific bacteria abundance (from baseline to follow-up)
DNA sequencing to determine specific bacteria abundance
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in functional mobility (from baseline to end of treatment)
Functional mobility will be assessed using the Timed Up and Go test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in functional mobility (from baseline to follow-up)
Functional mobility will be assessed using the Timed Up and Go test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in functional mobility (from baseline to end of treatment)
Functional mobility will be assessed using the Timed Up and Down Stairs test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in functional mobility (from baseline to follow-up)
Functional mobility will be assessed using the Timed Up and Down Stairs test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in functional mobility (from baseline to end of treatment)
Functional mobility will be assessed using the 30-second chair stand test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in functional mobility (from baseline to follow-up)
Functional mobility will be assessed using the 30-second chair stand test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in functional mobility (from baseline to end of treatment)
Functional mobility will be assessed using the 5-times Sit-To-Stand test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in functional mobility (from baseline to follow-up)
Functional mobility will be assessed using the 5-times Sit-To-Stand test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in functional mobility (from baseline to end of treatment)
Functional mobility will be assessed using the Quick test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in functional mobility (from baseline to follow-up)
Functional mobility will be assessed using the Quick test
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in the number and duration of viral infections (from baseline to end of treatment)
Number and duration of viral infections will be retrieved from medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in the number and duration of viral infections (from baseline to follow-up)
Number and duration of viral infections will be retrieved from medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in the number and duration of bacterial infections (from baseline to end of treatment)
Number and duration of bacterial infections will be retrieved from medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in the number and duration of bacterial infections (from baseline to follow-up)
Number and duration of bacterial infections will be retrieved from medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in the number and duration of fungal infections (from baseline to end of treatment)
Number and duration of fungal infections will be retrieved from medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in the number and duration of fungal infections (from baseline to follow-up)
Number and duration of fungal infections will be retrieved from medical records
Measured: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Reach: Exclusion rate (baseline)
Exclusion rate will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)
Reach: Non-participation rate (baseline)
Non-participation rate will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)
Reach: Recruitment rate (baseline)
Recruitment rate will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)
Reach: Test feasibility rate (from baseline to follow-up)
Feasibility rate will be evaluated using the Reach questionnaire
Measured: Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up)
Reach: Intervention session feasibility rate (end of treatment)
Intervention session feasibility rate will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)
Reach: Dropout rate (from end of treatment to follow-up)
Dropout rate will be evaluated using the Reach questionnaire (from end of treatment to follow-up)
Measured: Assessed at two time points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up)
Reach: Intervention satisfaction level (end of treatment)
Intervention satisfaction level will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)
Reach: Reasons why the patient participates in the trial (baseline)
Reasons why the patient participates in the trial will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)
Reach: Reasons why the patient does not participate in the trial (baseline)
Reasons why the patient does not participate in the trial will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)
Reach: Reasons why the patient is excluded (baseline)
Reasons why the patient is excluded will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)
Reach: Reasons why the patient drops out (from end of treatment to follow-up)
Reasons why the patient drops out will be evaluated using the Reach questionnaire (from end of treatment to follow-up)
Measured: Assessed at two points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up)
Reach: Medical conditions and sociocultural of the patient and caregivers (baseline)
Medical conditions and sociocultural of the patient and caregivers will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)
Reach: Sociocultural, economic and demographic characteristics of the patient and caregivers (baseline)
Sociocultural, economic and demographic characteristics of the patient and caregivers will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)
Reach: Reasons why efficacy and effectiveness research evaluation tests are not carried out (from baseline to follow-up)
Reasons why efficacy and effectiveness research evaluation tests are not carried out will be evaluated using the Reach questionnaire
Measured: Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up)
Reach: Reasons why the planned intervention sessions are not being carried out (end of treatment)
Reasons why the planned intervention sessions are not being carried out will be evaluated using the Reach questionnaire
Measured: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)
Effectiveness: RE-AIM Effectiveness component (end of treatment)
RE-AIM Effectiveness component will be evaluated using the Effectiveness questionnaire
Measured: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)
Effectiveness: Impact of the intervention on the results of the efficacy and effectiveness variables (end of treatment)
Impact of the intervention on the results of the efficacy and effectiveness variables will be evaluated using the Effectiveness questionnaire
Measured: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)
Effectiveness: Serious adverse effects of the intervention (from end of treatment to follow-up)
Serious adverse effects of the intervention will be evaluated using the Effectiveness questionnaire
Measured: Assessed at two points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up)
Maintenance: RE-AIM maintenance component (wear rate) (from end of treatment to follow-up)
RE-AIM maintenance component (wear rate) will be evaluated using the Maintenance questionnaire
Measured: Assessed at two time points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up)
Maintenance: Reasons why the end-of-follow-up evaluation of the research focused on efficacy and effectiveness was not carried out (follow-up)
Reasons why the end-of-follow-up evaluation of the research focused on efficacy and effectiveness was not carried out will be evaluated using the Maintenance questionnaire
Measured: Assessed at one time point (implementation phase): (1) 3 months after the end of treatment (follow-up)
Adoption: RE-AIM adoption component related to the clinical team (participation) (from baseline to follow-up)
RE-AIM adoption component related to the clinical team (participation) will be evaluated using the Adoption questionnaire
Measured: Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up)
Adoption: RE-AIM adoption component related to the clinical team (non-participation rate) (from baseline to follow-up)
RE-AIM adoption component related to the clinical team (non-participation rate) will be evaluated using the Adoption questionnaire
Measured: Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up)
Adoption: RE-AIM adoption component related to the clinical team (dropout rate) (from end of treatment to follow-up)
RE-AIM adoption component related to the clinical team (dropout rate) will be evaluated using the Adoption questionnaire
Measured: Assessed at two time points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up)
Adoption: Reasons why the clinical team participates in the trial (preparatory phase)
Reasons why the clinical team participates in the trial will be evaluated using the Adoption questionnaire
Measured: Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months
Adoption: Reasons why the clinical team does not participate in the trial (preparatory phase)
Reasons why the clinical team does not participate in the trial will be evaluated using the Adoption questionnaire
Measured: Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months
Adoption: Reasons why the clinical team drops out (from end of treatment to follow-up)
Reasons why the clinical team drops out will be evaluated using the Adoption questionnaire
Measured: Assessed at two time points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up)
Adoption: Sociocultural, economic, demographic and motivational characteristics of the clinical team (preparatory phase)
Sociocultural, economic, demographic and motivational characteristics of the clinical team will be evaluated using the Adoption questionnaire
Measured: Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months
Adoption: RE-AIM adoption component in relation to the environment (HSCT units) (from baseline to follow-up)
RE-AIM adoption component in relation to the environment (HSCT units) will be evaluated using the Adoption questionnaire
Measured: Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up)
Adoption: Participation rate of HSCT units (preparatory phase)
Participation rate of HSCT units will be evaluated using the Adoption questionnaire
Measured: Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months
Adoption: Facilitators/barriers to implementing the intervention (from baseline to follow-up)
Facilitators/barriers to implementing the intervention will be evaluated using the Adoption questionnaire
Measured: Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up)
Adoption: Suitability of the implementation strategies applied (closing phase)
Suitability of the implementation strategies applied will be evaluated using the Adoption questionnaire
Measured: Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months
Adoption: Differences between efficacy/effectiveness research and implementation research (closing phase)
Differences between efficacy/effectiveness research and implementation research will be evaluated using the Adoption questionnaire
Measured: Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months
Adoption: Intervention costs (closing phase)
Intervention costs will be evaluated using the Adoption questionnaire
Measured: Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months
Implementation: RE-AIM implementation component (feasibility rate) (from baseline to follow-up)
RE-AIM implementation component (feasibility rate) will be evaluated using the Implementation questionnaire
Measured: Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up)
Implementation: Level of satisfaction related to communication between families, patients, research team and clinician (end of treatment)
Level of satisfaction related to communication between families, patients, research team and clinician will be evaluated using the Implementation questionnaire
Measured: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)
Implementation: Degree of execution of the clinical team's implementation research functions within their usual practice (from baseline to follow-up)
Degree of execution of the clinical team's implementation research functions within their usual practice will be evaluated using the Implementation questionnaire
Measured: Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic System--CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alejandro Lucia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor-investigator, Alejandro Lucia, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300515
- Sponsor's protocol ID
- PI23/00396
- Acronym
- Henkō
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention in Childhood and Adolescence Hematopoietic Stem Cell Transplantation: The Henkō Trial
- ClinicalTrials.gov ID
- NCT06300515
- Acronym / sponsor ID
- Henkō / PI23/00396
- Conditions
- Hematopoietic System--Cancer
- Keywords
- exercise, pediatric cancer, health counseling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Alejandro LuciaUniversity, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Mar 2024 (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.
Thanks to medical advances, survival rates >5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.
Detailed description
Hematopoietic stem cell transplantation (HSCT), which is used to treat high-risk malignancies, as well as some other conditions or even autoimmune processes, consists of several phases: mobilization and subsequent collection of hematopoietic stem cells from the patient (autologous HSCT) or from a donor (allogeneic HSCT); pre-HSCT conditioning; infusion of patient/donor cells; establishment of a new immune and hematopoietic system in the recipient; and prophylaxis/treatment of possible adverse effects. Since the first successful allogeneic transplant was performed in 1968, thanks to the advances experienced in conditioning regimens, as well as in donor-recipient histocompatibility testing, in patient care and in the management of graft versus host disease (GvHD), together with the increase in the number of donors, the expectations of children and adolescents who receive HSCT have improved, achieving long-term survival rates (>5 years) >70%. Yet survivors are at high risk of suffering side effects and toxicities derived from the HSCT itself and/or the underlying disease, with subsequent functional decline. In addition, they show a higher risk of rehospitalization than pediatric cancer survivors who did not receive HSCT and tend to develop chronic pathologies (especially cardiometabolic conditions and frailty) at earlier stages of adulthood than the general population.
The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on the following outcomes assessed at 3 time points [start of hospitalization for HSCT (i.e., baseline), and 8 weeks and 3 months after hospital discharge, respectively]: muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). We will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Control Group (Active Comparator)During the intervention phase (hospitalization for hematopoietic stem cell transplantation (HSCT) and subsequent 8-week outpatient phase following discharge), the control group will participate in a Health Counseling Program (1 time/week) on aspects related to a healthy lifestyle such as reducing sedentary lifestyle, acquiring healthy nutritional habits, the importance sleep, screen use, and how to address barriers related to clinical status. We will adapt the program to the needs and timing of the patient's treatment, providing the content in one session/week orally (e.g. using presentations) and in writing (e.g. through brochures). |
| Exercise | Experimental | Behavioral: Intervention GroupDuring the intervention phase (hospitalization for hematopoietic stem cell transplantation (HSCT) and subsequent 8-week outpatient phase following discharge), the intervention group will participate in exactly the same Health Counseling Program as the Control group. Additionally, this group will perform an exercise program combining aerobic and muscle strength exercises |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 4 and 21 years.
- Undergoing hematopoietic stem cell transplantation (HSCT) for cancer diagnosis in complete remission or without remission, in 3 recruiting Hospitals in Madrid
- Undergoing treatment and follow-up in the same hospital.
- Speaking Spanish.
- Showing adequate baseline health status (Karnofsky >50, Eastern Cooperative Oncology Group scale score <2).
Key exclusion criteria (5 listed)
- Not being able to participate in the trial according to protocol.
- Comorbidity or acute condition not associated with the diagnosis and that contraindicates the practice of physical exercise, such as severe deficiencies in the locomotor, neurological, cardiovascular and pulmonary systems.
- Serious or chronic medical or psychiatric condition that may increase the risk associated with participation in the trial or that may interfere with the interpretation of the results and, in the opinion of the investigator in discussion with the team, makes having such condition inappropriate for entry to this study; inability to understand the study requirements.
- Not being able to attend hospital visits to perform assessment tests, nor participate in the physical exercise and health counseling program as stipulated in the protocol.
- Inability to understand the requirements of the study.
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 |
|---|---|---|
| Control Group (Active Comparator)Also: Health Counseling onlyDuring the intervention phase (hospitalization for HSCT and subsequent 8-week outpatient phase following discharge), the control group will participate in a Health Counseling Program (1 time/week) on aspects related to a healthy lifestyle such as reducing sedentary lifestyle, acquiring healthy nutritional habits, the importance sleep, screen use, and how to address barriers related to clinical status. We will adapt the program to the needs and timing of the patient's treatment, providing the content in one session/week orally (e.g. using presentations) and in writing (e.g. through brochures). | Behavioural | Control |
| Intervention GroupAlso: Health Counseling + ExerciseSame as Control Group + exercise program as described below: Same as Control Group + exercise program as described below: Hospital ward (during HSCT); and Hospital Gym or online (patients' home) during the outpatient phase. Frequency: 3-5 days/week. Session duration: 15 to 65 minutes. Muscle strength training (30 minutes): large muscle group exercises (upper/lower limb + trunk exercises) performed as a circuit using body weight or against resistance (against gravity and with body weight, elastic bands, dumbbells, weighted vests, machines), with a wide range of joint mobility and at submaximal/maximum voluntary speed. Aerobic training (10-20 minutes): bicycling, crank-ergometry, circuit-style exercises, and games. Inspiratory muscle training will also be performed (5 min daily, using a specific device that creates resistance against inspiration). | Behavioural | Exercise |
Primary outcome
Change in unilateral knee-extension muscle strength (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Unilateral knee-extension muscle strength will be assessed using a 5-RM test
158 secondary outcomes
Change in unilateral knee-extension muscle strength (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in handgrip strength (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in handgrip strength (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in maximum inspiratory muscle strength (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in maximum inspiratory muscle strength (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in VO2 (mL·kg-1·min-1) at peak (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in VO2 (mL·kg-1·min-1) at peak (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in VO2 (mL·kg-1·min-1) at the ventilatory threshold (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in VO2 (mL·kg-1·min-1) at the ventilatory threshold (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in power output (watts) at peak (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in power output (watts) at peak (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in power output (watts) at the ventilatory threshold (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in power output (watts) at the ventilatory threshold (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in walking distance covered (m) (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in walking distance covered (m) (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in heart rate recovery (beats/min) (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in heart rate recovery (beats/min) (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in range of motion of the ankle (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in range of motion of the ankle (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in physical activity (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in physical activity (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in body mass index (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in body mass index (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in waist-to-hip ratio (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in waist-to-hip ratio (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in arm circumference (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in arm circumference (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in lean mass (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in lean mass (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in fat mass (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in fat mass (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in visceral fat (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in visceral fat (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in fat percentage (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)
Change in fat percentage (from baseline to follow-up)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in bone mineral density of the total body (less head) (from baseline to end of treatment)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of 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 24 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Hematopoietic System--Cancer, run by Alejandro Lucia at 1 site in Spain.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Contact Carmen Fiuza-Luces, PhD (+34658961509, cfiuza.imas12@h12o.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in unilateral knee-extension muscle strength (from baseline to end of treatment) (time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.