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

NCT ID: NCT04406285

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leukemia Control Group

In this group the exercise program will be based on the standard protocol of physical therapy.

Group Type: ACTIVE_COMPARATOR

Standard protocol Leukemia

Intervention Type: OTHER

• 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).

Leukemia Experimental Group

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.

Group Type: EXPERIMENTAL

Periodic Resistance Training Program Leukemia

Intervention Type: OTHER

• 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.

Lymphoma Control Group

In this group the exercise program will be based on the standard protocol of physical therapy.

Group Type: ACTIVE_COMPARATOR

Standard protocol Lymphoma

Intervention Type: OTHER

• 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).

Lymphoma Experimental Group

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.

Group Type: EXPERIMENTAL

Periodic Resistance Training Program Lymphoma

Intervention Type: OTHER

• 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Fabrício Edler Macagnan

Sponsor-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fabrício Edler Macagnan

Porto Alegre, Rio Grande do Sul, Brazil

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

TMO-2019

Identifier Type: -

Identifier Source: org_study_id