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Active Not Recruiting
NCT05236062
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Conditions: Graft Vs Host Disease, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Dana-Farber Cancer Institute
Location: Brigham and Women's Hospital Boston Massachusetts
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.
Source: ClinicalTrials.gov (NCT05236062). StuddyBuddy aggregates publicly available trial information.