Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05236062

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

Led by Dana-Farber Cancer Institute · Updated on 2026-03-11

36

Participants Needed

2

Research Sites

282 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years old
  • Newly diagnosed with acute or chronic GVHD and starting corticosteroids at 0.20 mg/kg or greater for the first time since transplant
  • Received allogeneic stem cell transplant at Dana-Farber Cancer Institute
  • Physician's clearance to participate in moderate to vigorous exercise
  • Speak English
  • Currently participate in less than 60 minutes of structured exercise per week
  • Willing to travel to Dana-Farber Cancer Institute for necessary data collection
  • Able to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Plan for hospital admission within the next 13 weeks at recruitment
  • Not enrolled within 14 days after initial steroid treatment
  • Pre-existing musculoskeletal or cardiorespiratory conditions
  • Uncontrolled illness including active infection, uncontrolled diabetes, hypertension, or thyroid disease
  • Receiving other investigational agents or concurrent biological, chemotherapy, or radiation therapy
  • Other active malignancies
  • Participate in more than 60 minutes of structured exercise per week
  • Unable to travel to Dana-Farber Cancer Institute for data collection
  • Unable to comply with study safety monitoring requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

C

Christina Dieli-Conwright, PhD, MPH

CONTACT

J

Jordan Lane, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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