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Exercise for Graft-versus-Host Disease (RESTART Trial)

N/A

Recruiting

Led By Christina Dieli-Conwright

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

RESTART Trial Summary

This trial is to study if it's possible to do aerobic and resistance exercises for people with GVHD.

Who is the study for?

This trial is for adults over 18 who've had an allogeneic stem cell transplant at Dana-Farber Cancer Institute, are newly diagnosed with acute or chronic GVHD, and starting high-dose corticosteroids. They should do less than 60 minutes of structured exercise per week, be able to travel to the institute for data collection, have physician's clearance for moderate-vigorous exercise, and not be on other treatments.Check my eligibility

What is being tested?

The RESTART Trial is testing if a home-based aerobic and resistance exercise program can reduce complications from corticosteroids in patients with GVHD compared to a control group doing stretching exercises. Participants will either follow the exercise regimen or the attention control stretching program.See study design

What are the potential side effects?

Since this trial involves physical exercise programs rather than medication, side effects may include typical risks associated with new workout routines such as muscle soreness or strain. The exact side effects will depend on individual health conditions.

RESTART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am newly diagnosed with GVHD and starting high-dose corticosteroids for the first time since my transplant.

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I had a stem cell transplant from a donor at Dana-Farber Cancer Institute.

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I am over 18 years old.

RESTART Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients completing the exercise intervention sessions

Secondary outcome measures

Body Composition

Cardiopulmonary Fitness

Glycemic control level

+11 more

RESTART Trial Design

2Treatment groups

Experimental Treatment

Group I: Exercise GroupExperimental Treatment1 Intervention

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).

Group II: Attention control GroupExperimental Treatment1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Attention control

2013

Completed Phase 2

~2260

Exercise

2016

Completed Phase 1

~760

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,912 Total Patients Enrolled

Christina Dieli-ConwrightPrincipal InvestigatorDana-Farber Cancer Institute

2 Previous Clinical Trials

131 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05236062 — N/A

Graft-versus-Host Disease Research Study Groups: Attention control Group, Exercise Group

Graft-versus-Host Disease Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05236062 — N/A

Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05236062 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any new volunteers been accepted for this trial recently?

"Indeed, records on clinicaltrials.gov verify that this research project is actively searching for volunteers. It was initially posted in April 2022 and updated most recently in November of the same year. The target sample size consists of 36 participants from 2 different trial sites."

Answered by AI

How many participants have been signed up to partake in this trial?

"Affirmative. Records on the clinicaltrials.gov website attest that this investigation, which was first published in April 14th 2022, is currently enrolling participants. Approximately 36 individuals must be recruited from 2 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Christina Dieli-Conwright, PhD 2022. "Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05236062.

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