NCT05236062 Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
| NCT ID | NCT05236062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Graft Vs Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-04-14 |
| Primary Completion | 2026-09-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2022-04-14 with a primary completion date of 2026-09-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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 .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 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 * 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.
Contact & Investigator
Christina Dieli-Conwright
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT05236062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Graft Vs Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05236062 currently recruiting?
Yes, NCT05236062 is actively recruiting participants. Contact the research team at ChristinaM_Dieli-Conwright@dfci.harvard.edu for enrollment information.
Where is the NCT05236062 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT05236062 clinical trial?
NCT05236062 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Christina Dieli-Conwright at Dana-Farber Cancer Institute. The trial plans to enroll 36 participants.