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Exercise for Complications of Corticosteroids in GVHD (RESTART Trial)

This study, called the RESTART Trial, is looking at whether an exercise program can help patients with Graft-Versus-Host Disease (GVHD) who are taking corticosteroids. GVHD is a complication that can happen after a stem cell transplant where the new immune cells attack the patient's body. The study is testing two types of behavioral interventions: aerobic and resistance exercise, or stretching. Researchers want to see if the exercise program is practical for patients and if it can improve things like blood sugar control, body composition, and physical fitness. You might be able to join if you are over 18, newly diagnosed with acute or chronic GVHD, and starting corticosteroids for the first time since your transplant at Dana-Farber Cancer Institute. The main goal is to see how many patients complete the exercise program over 12 weeks. The current recruitment status is unclear.

Study design
This is an interventional study where participants are randomly assigned in a 2:1 ratio to either an aerobic and resistance exercise group or a stretching group. About 36 people are expected to participate.
What's involved
You would be in this study for 6 months. This includes four testing visits with blood draws and body composition scans (DXA).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which measures how many patients complete the exercise intervention, is assessed at 12 weeks.

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NCT05236062

Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial

Recruiting
NAAges 18+InterventionalSupportive care
Dana-Farber Cancer Institute
~36 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:ExerciseAttention control

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients completing the exercise intervention sessions
Measured over 12 weeks

Conditions

Graft Vs Host Disease
Acute-graft-versus-host Disease
Chronic Graft-versus-host-disease

Explore related trials

Graft Versus Host Disease

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Christina Dieli-Conwright · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Christina Dieli-Conwright, PhD, MPH
[email protected]
617-582-8321
Email the study team

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Do you actually qualify for this trial?

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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 .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

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.

What this trial measures

  • Proportion of patients completing the exercise intervention sessions12 weeks

    The primary outcome is feasibility and will be assessed by the proportion of patients completing the exercise intervention sessions with \>70% completion considered feasible.