Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT ID: NCT04496011

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2020-12-31

Brief 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

Study Design

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

Study Groups

Experimental Group

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®.

Group Type: EXPERIMENTAL

Aerobic training with cycle ergometer

Intervention Type: OTHER

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.

Group Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

Principal Investigators

Fabricio Edler Macagnan, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Locations

Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fabricio Edler Macagnan, PhD

Role: CONTACT

fabriciom@ufcspa.edu.br

+55 (51) 3309.8876

Facility Contacts

Fabricio Edler Macagnan, PhD

Role: primary

fabriciom@ufcspa.edu.br

+55 (51) 3309.8876

Other Identifiers

TMO 2020

Identifier Type: -

Identifier Source: org_study_id