Status:
RECRUITING
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Graft Vs Host Disease
Acute-graft-versus-host Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 s...
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 a...
Eligibility Criteria
Inclusion
- 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 1 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
- Have a plan for hospital admission within the next 13 weeks at the time of recruitment
- If patients are not enrolled within 7 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.
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05236062
Start Date
April 14 2022
End Date
October 31 2026
Last Update
February 19 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215