FatigueNCT04406285
Effects of Periodized and Autoregulated Resistance Training in Haematological Cancer Patients During the Treatent.
A study testing Standard protocol Leukemia, Periodic Resistance Training Program Leukemia and Standard protocol Lymphoma in people with Fatigue and Leukemia, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
Trial summary
Several clinical trials have demonstrated the positive impact of physical functioning and fatigue in patients who received training programs during the myeloablative chemotherapy with stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- What is being tested?
- Standard protocol Leukemia, Periodic Resistance Training Program Leukemia and Standard protocol Lymphoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients clinically diagnosed with Leukemia or Lymphoma, in the first or second line of treatment, undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation;
- Neurological and cognitive functions preserved;
- Physical conditions that enable participation in physical rehabilitation.
Who cannot join
- Clinical Complications that contraindicate physical therapy exercises, including the practice of cycle ergometer and resistance exercises;
- Previous musculoskeletal alteration that interferes in physical performance evaluation tests;
- Recent cardiovascular or pulmonary disease;
- Psychiatric or neurological disorder;
- Inability to walk on its own or presence of bone metastasis;
- Adherence on less than 50% of the total sessions of the study.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Fabrício Edler Macagnan
Porto Alegre, Rio Grande do Sul, 90050-170
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: Effects of Periodized and Autoregulated Resistance Training Programs in Haematological Cancer Patients Undergoing High-dose Chemotherapy and Hematopoietic Stem Cell Transplantation: A Randomized, Controlled Clinical Trial.
Several clinical trials have demonstrated the positive impact of physical functioning and fatigue in patients who received training programs during the myeloablative chemotherapy with stem cell transplantation. However, the heterogeneity among the forms of physical activity results in moderate to very low evidence available about benefits of physical exercise. In this randomized and controlled clinical trial, we will study the effects on physical performance and fatigue of periodic resistance training programs, with an autoregulated approach within a non-linear model, based on the individual patient response to cancer treatment.
Read the detailed description
The sample will consist of 66 patients diagnosed with leukemia and lymphoma undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation, who will be randomized into two groups. The physical performance and fatigue outcomes will be compared between the control and the experimental group. The control group will perform an exercise program based on the standard protocol of physical therapy, consisting of bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient's feedback (from 70% of maximum heart rate) and resistance exercises for muscle groups hip flexors, knee extensors and ankle plantar flexors and resistance training form arms, with weigths of 0,5 to 1,0 kg (10 repetitions, 1 set).
The experimental group will perform a periodic resistance training program, with an auto-regulated and a non-linear model, using the Submaximal Ergometer tests with incremental load (from 85% of maximaum heart rate or maximum effort related), 30-Second Chair Stand, Hand Grip strenght and submaximal effort of arms with weights of 0,5 to 1,0 kg.
- Conditions
- Fatigue, Leukemia, Lymphoma, Physical Disability
- Being tested
- Standard protocol Leukemia, Periodic Resistance Training Program Leukemia, Standard protocol Lymphoma, Periodic Resistance Training Program Lymphoma
- Keywords
- Fatigue, Physical Therapy, Hematological Malignancy
- Medical subject headings
- Fatigue, Leukemia, Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard protocol LeukemiaOther
- Bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient´s feedback (from 70% of maximum heart rate);
- Resistance exercises for muscle groups: hip flexors, knee extensors and ankle plantar flexors (10 repetitions, 1 sets);
- Resistance training for arms, using 0,5 kg or 1,0 kg dumbbels (10 repetitions, 1 sets).
Periodic Resistance Training Program LeukemiaOther
- Submaximal Ergometer tests with incremental load (from 85% of maximum heart rate or maximum effort related);
- 30-Second Chair Stand;
- Hand Grip Strength and submaximal arm effort using 0,5 kg or 1,0 kg dumbbels.
Standard protocol LymphomaOther
- Bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient´s feedback (from 70% of maximum heart rate);
- Resistance exercises for muscle groups: hip flexors, knee extensors and ankle plantar flexors (10 repetitions, 1 sets);
- Resistance training for arms, using 0,5 kg or 1,0 kg dumbbels (10 repetitions, 1 sets).
Periodic Resistance Training Program LymphomaOther
- Submaximal Ergometer tests with incremental load (from 85% of maximum heart rate or maximum effort related);
- 30-Second Chair Stand;
- Hand Grip Strength and submaximal arm effort using 0,5 kg or 1,0 kg dumbbels.
| Study group | Role | What they receive |
|---|---|---|
| Leukemia Control Group | Active comparator | In this group the exercise program will be based on the standard protocol of physical therapy. Receives: Other: Standard protocol Leukemia |
| Leukemia Experimental Group | Experimental | In this group the exercise program will be based on a periodic resistance training program, with an autoregulated approach within a non-linear model, based on the individual's patient daily response. Receives: Other: Periodic Resistance Training Program Leukemia |
| Lymphoma Control Group | Active comparator | In this group the exercise program will be based on the standard protocol of physical therapy. Receives: Other: Standard protocol Lymphoma |
| Lymphoma Experimental Group | Experimental | In this group the exercise program will be based on a periodic resistance training program, with an autoregulated approach within a non-linear model, based on the individual's patient daily response. Receives: Other: Periodic Resistance Training Program Lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Piper Fatigue Scale, developed by Piper et al. (1998), is a multidimensional measure of fatigue in the field of cancer research and includes subdomains of the behavioral, affective, sensorial and cognitive attributes / fatigue mood, composed of 22 items. The scores for each item range from 0 to 10 and can total 220 points. Higher values characterize a greater perception of fatigue. It will be applied on patient's evaluation day and on hospital discharge day.
Measured: Trough study completion, an average of 17 months
Physical Functioning Maximum Capacity
To evaluate the maximum capacity and endurance of the participants of this study, based on the concept of periodization (volume, intensity and frequency) and self-regulation (volume, intensity and magnitude according to daily readiness of the patient), by Fairman et al., (2017), the patient will perform a submaximal incremental exercise test in a cycle ergometer with electromagnetic braking, keeping the cadence fixed throughout the whole period of the test; the workload will be adjusted progressively every 1 minute until it reaches 85% of maximum heart rate or until the patient reports fatigue. At each load increase, the evaluation of the perceived effort will be performed through the BORG scale. The load, time and distance variables will be evaluated daily.
Measured: Trough study completion, an average of 17 months
Lower Limb Physical Functioning and Strength
The 30-Second Chair Stand evaluates lower limb strength and, indirectly, the risk of falls, especially in the elderly population (JONES, J., RIKLI, 2002). This way, it will compose the set of tests used to determine the physical performance by measuring the number of stands from an armless chair of standard height (45 cm) performed in 30 seconds. The test will be begin when the participant, seating on a neutral spine position and feet flat on the floor, will be instructed to rise to a full stand and return to the original seated position, as quickly as possible. The participant will be instructed to move at maximal speed until they either feel the need to stop or the 30-second time limit is reached. More than 8 unassisted stands for men and women are considered above average for their age, and those below the range as below average.
Measured: Trough study completion, an average of 17 months
Handgrip Strength Physical Functioning
A standard adjustable-handle hydraulic dynamometer will be used to measure hand grip strength as an index of upper limb strength. The Jamar® dynamometer, developed by Bechtol (1954), is considered the most accepted instrument ("gold standard") and is recommended by the American Society of Hand Therapists (ASHT) for being simple, to enable a quick and direct reading of the data and to enable its use in different fields of research. Three measurements of the manual grip strength should be performed in both hands, considering that the maximum difference between them does not exceed 10%, and the average of these being considered as the maximum value.
Measured: Trough study completion, an average of 17 months
Secondary outcomes (2)
Healt-related quality of life: EORTC QLQ-C30
General health-related quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), created as an initiative of the Quality of Life Group, from the EORTC (Aaronson et al., 1993) to assess the quality of life of cancer patients. The instrument is composed of 30 items, divided into five functioning scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), one scale that evaluates overall quality of life, five single terms (dyspnea, sleep disturbance, appetite loss, constipation, and diarrhea), and one separate item to evaluate financial impact. Responses are given on a 4-point Likert scale, except for the items that evaluate overall quality of life (items 29 and 30), which are given on a 7-point Likert scale. It will be applied on the day of the patient's evaluation and on the day of hospital discharge.
Measured: Trough study completion, an average of 17 months
Symptoms Assessment
The Edmonton Symptom Assessment Scalemorning will be applied to eavaluate symptoms of pain, tiredness, drowsiness, appetite, nausea, shortness of breath, depression, anxiety and well-being. It is a scale where the patient provides an auto-report on a score that can vary from 0 to 10, being score 0 absence of symptoms and 10 represents the most intense sensation experienced by the patient.
Measured: Trough study completion, an average of 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study startJun 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Patients will be included sequentially by convenience (according to the inclusion and exclusion criteria) in non-probabilistic form. The included individuals will be randomized by Random Allocation System software in two separate lists: one for patients diagnosed with leukemia (subdivided into a control and experimental group) and other for patients diagnosed with lymphoma (equally divided into a control and experimental group). The allocation ratio will be 1/1 in order to maintain balance in division between control and experimental groups. On the other hand, balancing the different clinical diagnoses will depend on chance, even though the historical average of the service shows similar proportions in the number of cases treated.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406285
- Sponsor's protocol ID
- TMO-2019
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodized and Autoregulated Resistance Training Programs in Haematological Cancer Patients Undergoing High-dose Chemotherapy and Hematopoietic Stem Cell Transplantation: A Randomized, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04406285
- Acronym / sponsor ID
- TMO-2019
- Conditions
- Fatigue, Leukemia, Lymphoma, Physical Disability
- Keywords
- Fatigue, Physical Therapy, Hematological Malignancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 May 2020 (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.
Several clinical trials have demonstrated the positive impact of physical functioning and fatigue in patients who received training programs during the myeloablative chemotherapy with stem cell transplantation. However, the heterogeneity among the forms of physical activity results in moderate to very low evidence available about benefits of physical exercise. In this randomized and controlled clinical trial, we will study the effects on physical performance and fatigue of periodic resistance training programs, with an autoregulated approach within a non-linear model, based on the individual patient response to cancer treatment.
Detailed description
The sample will consist of 66 patients diagnosed with leukemia and lymphoma undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation, who will be randomized into two groups. The physical performance and fatigue outcomes will be compared between the control and the experimental group. The control group will perform an exercise program based on the standard protocol of physical therapy, consisting of bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient's feedback (from 70% of maximum heart rate) and resistance exercises for muscle groups hip flexors, knee extensors and ankle plantar flexors and resistance training form arms, with weigths of 0,5 to 1,0 kg (10 repetitions, 1 set).
The experimental group will perform a periodic resistance training program, with an auto-regulated and a non-linear model, using the Submaximal Ergometer tests with incremental load (from 85% of maximaum heart rate or maximum effort related), 30-Second Chair Stand, Hand Grip strenght and submaximal effort of arms with weights of 0,5 to 1,0 kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients will be included sequentially by convenience (according to the inclusion and exclusion criteria) in non-probabilistic form. The included individuals will be randomized by Random Allocation System software in two separate lists: one for patients diagnosed with leukemia (subdivided into a control and experimental group) and other for patients diagnosed with lymphoma (equally divided into a control and experimental group). The allocation ratio will be 1/1 in order to maintain balance in division between control and experimental groups. On the other hand, balancing the different clinical diagnoses will depend on chance, even though the historical average of the service shows similar proportions in the number of cases treated.
| Arm | Type | Receives |
|---|---|---|
| Leukemia Control Group | Active comparator | Other: Standard protocol LeukemiaIn this group the exercise program will be based on the standard protocol of physical therapy. |
| Leukemia Experimental Group | Experimental | Other: Periodic Resistance Training Program LeukemiaIn this group the exercise program will be based on a periodic resistance training program, with an autoregulated approach within a non-linear model, based on the individual's patient daily response. |
| Lymphoma Control Group | Active comparator | Other: Standard protocol LymphomaIn this group the exercise program will be based on the standard protocol of physical therapy. |
| Lymphoma Experimental Group | Experimental | Other: Periodic Resistance Training Program LymphomaIn this group the exercise program will be based on a periodic resistance training program, with an autoregulated approach within a non-linear model, based on the individual's patient daily response. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients clinically diagnosed with Leukemia or Lymphoma, in the first or second line of treatment, undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation;
- Neurological and cognitive functions preserved;
- Physical conditions that enable participation in physical rehabilitation.
Key exclusion criteria (6 listed)
- Clinical Complications that contraindicate physical therapy exercises, including the practice of cycle ergometer and resistance exercises;
- Previous musculoskeletal alteration that interferes in physical performance evaluation tests;
- Recent cardiovascular or pulmonary disease;
- Psychiatric or neurological disorder;
- Inability to walk on its own or presence of bone metastasis;
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 |
|---|---|---|
| Standard protocol Leukemia* Bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient´s feedback (from 70% of maximum heart rate); * Resistance exercises for muscle groups: hip flexors, knee extensors and ankle plantar flexors (10 repetitions, 1 sets); * Resistance training for arms, using 0,5 kg or 1,0 kg dumbbels (10 repetitions, 1 sets). | Other | Leukemia Control Group |
| Periodic Resistance Training Program Leukemia* Submaximal Ergometer tests with incremental load (from 85% of maximum heart rate or maximum effort related); * 30-Second Chair Stand; * Hand Grip Strength and submaximal arm effort using 0,5 kg or 1,0 kg dumbbels. | Other | Leukemia Experimental Group |
| Standard protocol Lymphoma* Bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient´s feedback (from 70% of maximum heart rate); * Resistance exercises for muscle groups: hip flexors, knee extensors and ankle plantar flexors (10 repetitions, 1 sets); * Resistance training for arms, using 0,5 kg or 1,0 kg dumbbels (10 repetitions, 1 sets). | Other | Lymphoma Control Group |
| Periodic Resistance Training Program Lymphoma* Submaximal Ergometer tests with incremental load (from 85% of maximum heart rate or maximum effort related); * 30-Second Chair Stand; * Hand Grip Strength and submaximal arm effort using 0,5 kg or 1,0 kg dumbbels. | Other | Lymphoma Experimental Group |
Primary outcome
Fatigue
Time frame: Trough study completion, an average of 17 months
Piper Fatigue Scale, developed by Piper et al. (1998), is a multidimensional measure of fatigue in the field of cancer research and includes subdomains of the behavioral, affective, sensorial and cognitive attributes / fatigue mood, composed of 22 items. The scores for each item range from 0 to 10 and can total 220 points. Higher values characterize a greater perception of fatigue. It will be applied on patient's evaluation day and on hospital discharge day.
Physical Functioning Maximum Capacity
Time frame: Trough study completion, an average of 17 months
To evaluate the maximum capacity and endurance of the participants of this study, based on the concept of periodization (volume, intensity and frequency) and self-regulation (volume, intensity and magnitude according to daily readiness of the patient), by Fairman et al., (2017), the patient will perform a submaximal incremental exercise test in a cycle ergometer with electromagnetic braking, keeping the cadence fixed throughout the whole period of the test; the workload will be adjusted progressively every 1 minute until it reaches 85% of maximum heart rate or until the patient reports fatigue. At each load increase, the evaluation of the perceived effort will be performed through the BORG scale. The load, time and distance variables will be evaluated daily.
Lower Limb Physical Functioning and Strength
Time frame: Trough study completion, an average of 17 months
The 30-Second Chair Stand evaluates lower limb strength and, indirectly, the risk of falls, especially in the elderly population (JONES, J., RIKLI, 2002). This way, it will compose the set of tests used to determine the physical performance by measuring the number of stands from an armless chair of standard height (45 cm) performed in 30 seconds. The test will be begin when the participant, seating on a neutral spine position and feet flat on the floor, will be instructed to rise to a full stand and return to the original seated position, as quickly as possible. The participant will be instructed to move at maximal speed until they either feel the need to stop or the 30-second time limit is reached. More than 8 unassisted stands for men and women are considered above average for their age, and those below the range as below average.
Handgrip Strength Physical Functioning
Time frame: Trough study completion, an average of 17 months
A standard adjustable-handle hydraulic dynamometer will be used to measure hand grip strength as an index of upper limb strength. The Jamar® dynamometer, developed by Bechtol (1954), is considered the most accepted instrument ("gold standard") and is recommended by the American Society of Hand Therapists (ASHT) for being simple, to enable a quick and direct reading of the data and to enable its use in different fields of research. Three measurements of the manual grip strength should be performed in both hands, considering that the maximum difference between them does not exceed 10%, and the average of these being considered as the maximum value.
2 secondary outcomes
Healt-related quality of life: EORTC QLQ-C30
Time frame: Trough study completion, an average of 17 months
Symptoms Assessment
Time frame: Trough study completion, an average of 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard protocol Leukemia, Periodic Resistance Training Program Leukemia and Standard protocol Lymphoma in people with Fatigue and Leukemia, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
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?
Fatigue (time frame: Trough study completion, an average of 17 months). The study lists 4 primary outcomes in all. 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 28 May 2020.