Clinical trial NCT05236062: Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Official title: Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graft Vs Host Disease
Acute-graft-versus-host Disease
Chronic Graft-versus-host-disease
Keywords: Graft Vs Host Disease
Acute-graft-versus-host Disease
Chronic Graft-versus-host-disease
Corticosteroids
Allogeneic stem cell transplant
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: This research study is a feasibility study, which is the first-time investigators are examining an aerobic and resistance exercise (A+R) in patients diagnosed with acute or chronic GVHD after having an allogeneic stem cell transplant and if participating in a specific exercise program can improve glycemic control, body composition, physical fitness and function, and patient-reported outcomes.

This study consists of participants randomly assigned in 2(A+R):1(AC) ratio to one of two groups:

* Aerobic and resistance exercise (A+R), or
* Attention control (AC)

The A+R group will be asked to perform aerobic exercise, which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting), to help build muscle mass and strength. The AC group will be asked to perform stretching only and not to change their activity behavior.

All participants will also undergo four testing visits involving four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).

Participants will be in this research study for 6 months.

It is expected that about 36 people will take part in this research study.

Eligibility criteria: 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 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
* 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 7 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.

Primary outcomes:
measure: Proportion of patients completing the exercise intervention sessions
timeFrame: 12 weeks
Secondary outcomes:
measure: Glycemic control level
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Body Composition
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Cardiopulmonary Fitness
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Physical function - Margaria Stair Climb
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Physical Fitness
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Physical Function - Handgrip Strength
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Physical Function - Timed Up and Go
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Physical Function - 6 minute walk test
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Muscular Strength
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Patient reported outcomes - Fatigue
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Patient reported outcomes - Function
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Patient reported outcomes - Quality of Life
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Patient reported outcomes - Anxiety and Depression
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
measure: Patient reported outcomes - Sleep
timeFrame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright
role: PRINCIPAL_INVESTIGATOR
References: