Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Behavioralaerobic and resistance exercise
Attention control
Behavioralstretching
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Exercise GroupExperimental treatment 1 intervention
Group B: Attention control GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 weeksSecondary outcomes
1
Glycemic control level
Glycemic control level change will be measured by Homeostasis Model Assessment (HOMA). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame
Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up2
Body Composition
Body Composition Index change will be measured by Dual Energy X-Ray Absorptiometry (DEXA). Differences in lean mass, fat mass, and body fat % between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame
Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up3
Cardiopulmonary Fitness
Cardiopulmonary fitness will be measured by a submaximal graded exercise cycling test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame
Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up4
Physical function - Margaria Stair Climb
Functional power will be measured using the Margaria Stair Climb test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame
Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-upSponsors and contacts
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Source ClinicalTrials.gov