NCT04406285

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Federal University of Health Science of Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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).
OTHER	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	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	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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-07-01
• Completion: 2021-12-01
• First posted: 2020-05-28
• Last updated: 2020-05-28

Locations

2 sites across 1 country: Brazil