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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leukemia Control Group | Active Comparator | In this group the exercise program will be based on the standard protocol of physical therapy. |
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| 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. |
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| Lymphoma Control Group | Active Comparator | In this group the exercise program will be based on the standard protocol of physical therapy. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard protocol Leukemia | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FabrĆcio Edler Macagnan | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil | ||
| Universidade Federal de CiĆŖncias da SaĆŗde de Porto Alegre |
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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.
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| Periodic Resistance Training Program Leukemia | Other |
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| Standard protocol Lymphoma | Other |
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| Periodic Resistance Training Program Lymphoma | Other |
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| 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 JamarĀ® 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. | Trough study completion, an average of 17 months |
| 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. | Trough study completion, an average of 17 months |
| Porto Alegre |
| Rio Grande do Sul |
| 90050-170 |
| Brazil |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C077194 | AIEOP acute lymphoblastic leukemia protocol |
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