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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05236062
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise — BEHAVIORAL
    aerobic and resistance exercise
  • Attention control — BEHAVIORAL
    stretching

Study Details

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

Key Dates

Start date
Apr 14, 2022
Status verified
Mar 2026
Primary completion
Sep 9, 2026
Completion
Sep 9, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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).
  • Experimental: 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).

Primary Outcome Measure

Proportion of patients completing the exercise intervention sessions [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Christina Dieli-Conwright, PhD, MPH
[email protected]
617-582-8321
Christina Dieli-Conwright, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Christina Dieli-Conwright, PhD, MPH
[email protected]
617-632-3800
PhD, MPH
Christina Dieli-Conwright, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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