Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Exercise
- Attention control
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov