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

Federal University of Health Science of Porto Alegre

Status: Unknown

Conditions: Physical Disability; Lymphoma; Leukemia; Fatigue

Treatments: Other: Periodic Resistance Training Program Leukemia; Other: Standard protocol Leukemia; Other: Periodic Resistance Training Program Lymphoma; Other: Standard protocol Lymphoma

Study type: Interventional

Funder types: Other

Identifiers

NCT04406285

TMO-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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66 participants in 4 patient groups

Leukemia Control Group

Active Comparator group

Description:

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

Treatment:

Other: Standard protocol Leukemia

Leukemia Experimental Group

Experimental group

Description:

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.

Treatment:

Other: Periodic Resistance Training Program Leukemia

Lymphoma Control Group

Active Comparator group

Description:

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

Treatment:

Other: Standard protocol Lymphoma

Lymphoma Experimental Group

Experimental group

Description:

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.

Treatment:

Other: Periodic Resistance Training Program Lymphoma