NCT05236062Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 19 Jan 2022
- Start date
- 14 Apr 2022
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Dana-Farber Cancer Institute
- NCT number
- NCT05236062
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 14 Apr 2022 to the primary completion date, 28 Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- If patients are not enrolled within 14 days after initial steroid treatment, they will be ineligible
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Other illness
- 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 with other active malignancies
- Unable to travel to Dana-Farber Cancer Institute for necessary data collection
Other
- Have a plan for hospital admission within the next 13 weeks at the time of recruitment
- Participate in more than 60 minutes of structured exercise/week
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.