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

NCT05236062 · Dana-Farber Cancer Institute
In plain English

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Official title
Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial
About this study
This research study is a feasibility study, which is the first-time investigators are examining an aerobic and resistance exercise (A+R) in patients diagnosed with acute or chronic GVHD after having an allogeneic stem cell transplant and if participating in a specific exercise program can improve glycemic control, body composition, physical fitness and function, and patient-reported outcomes. This study consists of participants randomly assigned in 2(A+R):1(AC) ratio to one of two groups: * Aerobic and resistance exercise (A+R), or * Attention control (AC) The A+R group will be asked to perform aerobic exercise, which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting), to help build muscle mass and strength. The AC group will be asked to perform stretching only and not to change their activity behavior. All participants will also undergo four testing visits involving four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA). Participants will be in this research study for 6 months. It is expected that about 36 people will take part in this research study.
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.
Study design
Enrollment target: 36 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-04-14
Estimated completion: 2027-09-09
Last updated: 2026-03-11
Interventions
Behavioral: ExerciseBehavioral: Attention control
Primary outcomes
  • Proportion of patients completing the exercise intervention sessions (12 weeks)
Sponsor
Dana-Farber Cancer Institute · other
Contacts & investigators
ContactChristina Dieli-Conwright, PhD, MPH · contact · ChristinaM_Dieli-Conwright@dfci.harvard.edu · 617-582-8321
ContactJordan Lane, MS · contact · jordan_lane@dfci.harvard.edu · 617-582-7494
InvestigatorChristina Dieli-Conwright · principal_investigator, Dana-Farber Cancer Institute
All locations (2)
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial · TrialPath