RECRUITING

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

Description

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

Graft Vs Host DiseaseAcute-graft-versus-host DiseaseChronic Graft-versus-host-disease
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Related Conditions:

Graft Vs Host DiseaseAcute-graft-versus-host DiseaseChronic Graft-versus-host-disease

Study Overview

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Study Details

Study overview

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

Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial

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

Condition
Graft Vs Host Disease
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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.
  • * Have a plan for hospital admission within the next 13 weeks at the time of recruitment
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dana-Farber Cancer Institute,

Christina Dieli-Conwright, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

2025-10-31