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
Dana-Farber Cancer Institute
36 participants
Apr 14, 2022
INTERVENTIONAL
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
Eligibility
Inclusion Criteria8
- 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 .20 mg/kg or greater for the first time 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 60 minutes of structured 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 Criteria9
- 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
- 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 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.
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Interventions
aerobic and resistance exercise
stretching
Locations(2)
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NCT05236062