NCT05236062

Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial

Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant. The names of the study interventions involved in this study are: * Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program * Attention control (AC) - Home-based stretching program

Detailed description

This research study is a feasibility study, which is the first-time investigators are examining an aerobic and resistance exercise (A+R) in patients diagnosed with acute or chronic GVHD after having an allogeneic stem cell transplant and if participating in a specific exercise program can improve glycemic control, body composition, physical fitness and function, and patient-reported outcomes. This study consists of participants randomly assigned in 2(A+R):1(AC) ratio to one of two groups: * Aerobic and resistance exercise (A+R), or * Attention control (AC) The A+R group will be asked to perform aerobic exercise, which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting), to help build muscle mass and strength. The AC group will be asked to perform stretching only and not to change their activity behavior. All participants will also undergo four testing visits involving four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA). Participants will be in this research study for 6 months. It is expected that about 36 people will take part in this research study.

Conditions

• Graft Vs Host Disease
• Acute-graft-versus-host Disease
• Chronic Graft-versus-host-disease

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	aerobic and resistance exercise
BEHAVIORAL	Attention control	stretching

Timeline

• Start date: 2022-04-14
• Primary completion: 2026-09-09
• Completion: 2027-09-09
• First posted: 2022-02-11
• Last updated: 2026-03-11

Locations

2 sites across 1 country: United States