NCT04496011

Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation

Effect of the Use of a Cycloergometer on the Physical Performance of Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized and Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Federal University of Health Science of Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Fatigue
• Leukemia
• Lymphoma
• Multiple Myeloma
• Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
OTHER	Aerobic training with cycle ergometer	Patients start with an initial warm-up of 2 minutes, with rotations per minute free, without load. Progressively, the load of the exercise cycle increases every minute up to the supported limit or up to 60% - 70% of maximum heart rate (HRmax). The training will be carried out for 20 continuous minutes, being interrupted whenever the heart rate (HR) reaches 90% of the maximum expected for the age and / or the loss of effort perceived in the BORG scale, above 8 on a scale of 0 to 10.

Timeline

• Start date: 2020-03-02
• Primary completion: 2020-09-30
• Completion: 2020-12-01
• First posted: 2020-08-03
• Last updated: 2020-08-03

Locations

1 site across 1 country: Brazil