Recruiting

Exercise

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05236062

Conditions

Graft Vs Host Disease

Acute-graft-versus-host Disease

Chronic Graft-versus-host-disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise

Attention control

Study Details

Brief 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

Conditions

Graft Vs Host Disease

Acute-graft-versus-host Disease

Chronic Graft-versus-host-disease

Study ID

NCT05236062

Start date

Apr 14, 2022

Status verified date

Mar, 2026

Completion date

Sep 9, 2027

Anticipated

Primary completion date

Sep 9, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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 .20 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:

  • Have a plan for hospital admission within the next 13 weeks at the time of recruitment
  • If patients are not enrolled within 14 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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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).

Interventions

Exercise

aerobic and resistance exercise

Attention control

stretching

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Christina Dieli-Conwright, PhD, MPH

617-582-8321ChristinaM_Dieli-Conwright@dfci.harvard.edu

Jordan Lane, MS

617-582-7494jordan_lane@dfci.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Christina Dieli-Conwright, PhD, MPH

617-582-8321ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU

Principal Investigator:

Christina Dieli-Conwright, PhD, MPH

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina Dieli-Conwright, PhD, MPH

617-632-3800ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator:

Christina Dieli-Conwright, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Graft Vs Host Disease
  • Acute-graft-versus-host Disease
  • Chronic Graft-versus-host-disease
  • Corticosteroids
  • Allogeneic stem cell transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-03-11.