Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
NCT ID: NCT05236062
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2022-04-14
2026-10-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise Group
Home-based, virtually supervised via Zoom, 3x weekly for 12-weeks aerobic and resistance exercise program
Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).
Exercise
aerobic and resistance exercise
Attention control Group
Home-based, 12-week stretching program only with participants asked not to change their activity behavior.
Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).
Attention control
stretching
Interventions
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Exercise
aerobic and resistance exercise
Attention control
stretching
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of 1 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
* If patients are not enrolled within 7 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.
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Christina Dieli-Conwright, PhD
Principal Investigator
Principal Investigators
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Christina Dieli-Conwright
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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PhD, MPH
Role: backup
Other Identifiers
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21-618
Identifier Type: -
Identifier Source: org_study_id
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