Actively Recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial
Led by Dana-Farber Cancer Institute · Updated on 2026-03-11
36
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 2:1 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.
CONDITIONS
Brief Title
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of 0.20 mg/kg or greater for the first time since transplant
- Received allogeneic stem cell transplant at Dana-Farber Cancer Institute
- Physician's clearance to participate in moderate to vigorous intensity exercise
- Speak English
- Currently participate in less than 60 minutes of structured exercise per week
- Willing to travel to Dana-Farber Cancer Institute for necessary data collection
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Planned hospital admission within the next 13 weeks at recruitment
- Not enrolled within 14 days after initial steroid treatment
- Pre-existing musculoskeletal or cardiorespiratory conditions
- Uncontrolled illnesses including active infection, uncontrolled diabetes, hypertension, or thyroid disease
- Receiving other investigational agents or concurrent biological, chemotherapy, or radiation therapy
- Other active malignancies
- Participate in more than 60 minutes of structured exercise per week
- Unable to travel to Dana-Farber Cancer Institute for data collection
- May not be able to comply with safety monitoring requirements as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 12 weeks
Participants are randomly assigned to either a 12-week home-based aerobic and resistance exercise program or a 12-week home-based stretching program. The exercise group performs aerobic and resistance training to improve muscle strength and cardiovascular fitness, while the control group performs stretching only without changing activity behavior.
Virtually supervised exercise or stretching sessions 3 times weekly
Duration - 6 months
Participants undergo four testing visits over 6 months involving blood draws and body composition scans to evaluate health outcomes related to exercise and corticosteroid complications.
4 testing visits including blood draws and 3 body composition scans
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
C
Christina Dieli-Conwright, PhD, MPH
J
Jordan Lane, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here