Feasibility Study of Home-Based Aerobic and Resistance Exercise Versus Stretching in Adults With Acute or Chronic Graft-Versus-Host Disease After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating whether a home-based aerobic and resistance exercise program is feasible for patients diagnosed with acute or chronic Graft-Versus-Host Disease GVHD after receiving an allogeneic stem cell transplant. This study aims to see if this exercise approach can improve blood sugar control, body composition, physical fitness, and patient-reported health outcomes compared to a stretching program. The trial is sponsored by the Dana-Farber Cancer Institute and involves participants newly starting corticosteroid treatment for GVHD. Participants are randomly assigned in a 21 ratio to either a 12-week aerobic and resistance exercise program or a stretching-only control group. The exercise group will perform aerobic activities and resistance exercises like dumbbell lifting three times a week, supervised virtually via Zoom. Both groups will have four testing visits over six months, including blood draws and body scans using dual-energy x-ray absorptiometry DXA. During the six-month study, participants will complete assessments at baseline, mid-treatment, post-treatment, and follow-up weeks. These include tests of glycemic control, body composition, cardiopulmonary fitness, muscular strength, physical function, and patient-reported outcomes such as fatigue, quality of life, anxiety, depression, and sleep. The main measure is the proportion of patients completing the exercise sessions over 12 weeks, with ongoing safety monitoring throughout the study.

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