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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Christina Dieli-Conwright, PhD, MPH
ChristinaM_Dieli-Conwright@dfci.harvard.edu
617-582-8321
Backup
Mary Norris, MS
maryk_norris@dfci.harvard.edu
857-215-0195
Time Frame
Start Date: 2022-04-14
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 36
Treatments
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).
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov