Effects of Periodized and Autoregulated Resistance Training in Haematological Cancer Patients During the Treatent.

Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04406285
• Other study ID #: TMO-2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: December 2021

Study information

• Verified date: May 2020
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fatigue
• Leukemia
• Lymphoma
• Physical Disability

Intervention

Other:
• 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).
• 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.
• 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).
• 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.

Locations

Country	Name	City	State
Brazil	Fabrício Edler Macagnan	Porto Alegre	Rio Grande Do Sul
Brazil	Universidade Federal de Ciências da Saúde de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.	Trough study completion, an average of 17 months
Primary	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.	Trough study completion, an average of 17 months
Secondary	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.	Trough study completion, an average of 17 months
Secondary	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