NCT05236062

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Apr 2022Sep 2027

First Submitted

Initial submission to the registry

January 19, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

January 19, 2022

Last Update Submit

March 9, 2026

Conditions

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

Keywords

Graft Vs Host DiseaseAcute-graft-versus-host DiseaseChronic Graft-versus-host-diseaseCorticosteroidsAllogeneic stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients completing the exercise intervention sessions

    The primary outcome is feasibility and will be assessed by the proportion of patients completing the exercise intervention sessions with \>70% completion considered feasible.

    12 weeks

Secondary Outcomes (14)

  • Glycemic control level

    Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

  • Body Composition

    Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

  • Cardiopulmonary Fitness

    Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

  • Physical function - Margaria Stair Climb

    Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

  • Physical Fitness

    Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

  • +9 more secondary outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL

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).

Behavioral: Exercise

Attention control Group

EXPERIMENTAL

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).

Behavioral: Attention control

Interventions

ExerciseBEHAVIORAL

aerobic and resistance exercise

Exercise Group
Attention controlBEHAVIORAL

stretching

Attention control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Graft vs Host DiseaseBronchiolitis Obliterans Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Immune System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Christina Dieli-Conwright

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, PhD, MPH

CONTACT

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

Jordan Lane, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 11, 2022

Study Start

April 14, 2022

Primary Completion (Estimated)

September 9, 2026

Study Completion (Estimated)

September 9, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US(2)