Exercise Intervention for Improving Complications of Corticosteroids in Patients with Graft-versus-Host Disease following Stem Cell Transplant, The RESTART Trial

Inclusion Criteria

• Over 18 years old; children under the age of 18 will be excluded due to rarity of disease.
• Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of 0.20 mg/kg or greater since transplant.
• Received allogeneic stem cell transplant (any conditioning, any donor) at Dana-Farber Cancer Institute.
• Physician’s clearance to participate in moderate-vigorous intensity exercise.
• Speak English.
• Currently participate in less than or equal to 60 minutes of structured moderate-to-vigorous exercise/week.
• Willing to travel to Dana-Farber Cancer Institute for necessary data collection.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Have a plan for hospital admission within the next 13 weeks at the time of recruitment.
• If patients are not enrolled within 14 days after initial steroid treatment, they will be ineligible.
• Pre-existing musculoskeletal or cardiorespiratory conditions that prevent participation in moderate-vigorous intensity exercise.
• Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease.
• Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
• Patients with other active malignancies.
• Participate in more than 60 minutes of structured moderate-to-vigorous exercise/week.
• Unable to travel to Dana-Farber Cancer Institute for necessary data collection.
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.