Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation

Federal University of Health Science of Porto Alegre

Status: Unknown

Conditions: Multiple Myeloma; Hematopoietic Stem Cell Transplantation; Lymphoma; Leukemia; Fatigue

Treatments: Other: Aerobic training with cycle ergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04496011

TMO 2020

Details and patient eligibility

About

Physiological changes caused by hematological diseases associated with high dose chemotherapy have a negative impact on patient's functionality, making them more fragile and vulnerable after hematopoietic cell transplantation. Currently, randomized studies have shown that physical exercise can contribute to improve Quality of Life of these patients. In this randomized controlled trial, we will study the effect of using the bicycle ergometer on the physical performance of patients undergoing transplantation of hematopoietic stem cells (HSCT).

Full description

The sample consists of 30 patients diagnosed with leukemia, lymphoma and multiple myeloma, undergoing high-dose chemotherapy and hematopoietic stem cells transplantation, who will be randomized into two groups. The results of muscle strength in the lower limbs, general mobility, fatigue and clinical symptoms will be compared between the control group and the experimental group.

The control group will perform an exercise program based on the standard protocol of the physiotherapy service, where exercises are performed to gain strength in muscle groups of the upper and lower limbs, range of motion, balance and functional movements. The experimental group will perform the same exercises as the control group, added to a training program using a bicycle ergometer, with an incremental load (from 60% to 70% of the maximum heart rate) for 20 minutes.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (18-70 years) scheduled to perform the first HSCT;
• Be with a preserved neurological function and full cognition;
• Have clinical conditions that allow participation in the motor physiotherapy program;
• Be agreed with a study proposal and sign the free and informed consent form (ICF).

Exclusion criteria

• Develop clinical complications that contraindicate the performance of motor physiotherapy including the practice of the cycle ergometer;
• Present a previous musculoskeletal alteration that interferes with the performance of physical performance assessment tests;
• Recent cardiovascular or pulmonary disease;
• Psychiatric or neurological disorder;
• Need for gait assistance or presence of bone metastasis
• Adherence below 50% of the total motor physiotherapy protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental Group

Experimental group

Description:

In this group the exercise program will be based on the protocol of Control Group, without the exception of walking training, adding aerobic capacity training using the bicycle ergometer, model CBL11 Classic® from ACT®.

Treatment:

Other: Aerobic training with cycle ergometer

Group Control

No Intervention group

Description:

In this group the exercise program is based on the standard physiotherapy protocol that is part of the care routines performed at the bone marrow transplant service. It includes essential components of a rehabilitation program: range of motion, balance training, gait and strength of the upper and lower limbs