Exercise for Graft-Versus-Host Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Graft-Versus-Host Disease+2 MoreExercise - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Graft-Versus-Host Disease
  • Graft Versus Host Disease
  • Chronic Graft-versus-Host Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

12 weeks
Proportion of patients completing the exercise intervention sessions
Week 25
Body Composition
Cardiopulmonary Fitness
Glycemic control level
Muscular Strength
Patient reported outcomes - Anxiety and Depression
Fatigue
Patient reported outcomes - Function
Patient reported outcomes - Quality of Life
Patient reported outcomes - Sleep
Physical Fitness
Physical Function - 6 minute walk test
Physical Function - Handgrip Strength
Physical Function - Timed Up and Go
Physical function - Margaria Stair Climb

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Exercise Group
1 of 2
Attention control Group
1 of 2

Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: Exercise · No Placebo Group · N/A

Exercise Group
Behavioral
Experimental Group · 1 Intervention: Exercise · Intervention Types: Behavioral
Attention control Group
Behavioral
Experimental Group · 1 Intervention: Attention control · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760
Attention control
2013
Completed Phase 2
~2260

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,780 Total Patients Enrolled
Christina Dieli-ConwrightPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
131 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received allogeneic stem cell transplant at Dana-Farber Cancer Institute.
You have a physician's clearance to participate in moderate-vigorous intensity exercise.
You are willing to travel to Dana-Farber Cancer Institute for necessary data collection.
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent document.
You must speak English.