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

Primary Purpose

Graft Vs Host Disease, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Attention control
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Graft Vs Host Disease focused on measuring Graft Vs Host Disease, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease, Corticosteroids, Allogeneic stem cell transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise Group

Attention control Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Physical Fitness
Physical Fitness will be measured by the short physical performance battery (SPPB). 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.
Physical Function - Handgrip Strength
Handgrip strength will be measured by a hand-held dynamometer. 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.
Physical Function - Timed Up and Go
Physical function will be assessed with the timed-up-and-go (TUG) 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.
Physical Function - 6 minute walk test
Physical function will be assessed with the 6 minute walk test (6MWT). 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.
Muscular Strength
Muscular strength will be assessed with a 10 repetition maximum 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.
Patient reported outcomes - Fatigue
Fatigue will be measured by the PROMIS cancer fatigue short form. 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.
Patient reported outcomes - Function
Function will be measured by the Vulnerable Elders Survey (VES). 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.
Patient reported outcomes - Quality of Life
Quality of life will be assessed by the functional assessment of cancer therapy - bone marrow transplant (FACT-BMT). 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.
Patient reported outcomes - Anxiety and Depression
Anxiety and depression will be assessed by the Hospital Anxiety and Depression Scale (HADS). 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. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Patient reported outcomes - Sleep
Sleep will be assessed by the Pittsburg sleep quality index (PSQI). 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.

Full Information

First Posted
January 19, 2022
Last Updated
February 16, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05236062
Brief Title
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Acronym
RESTART
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Attention control Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
aerobic and resistance exercise
Intervention Type
Behavioral
Intervention Name(s)
Attention control
Intervention Description
stretching
Primary Outcome Measure Information:
Title
Proportion of patients completing the exercise intervention sessions
Description
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 weeks
Secondary Outcome Measure Information:
Title
Glycemic control level
Description
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-up
Title
Body Composition
Description
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-up
Title
Cardiopulmonary Fitness
Description
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-up
Title
Physical function - Margaria Stair Climb
Description
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-up
Title
Physical Fitness
Description
Physical Fitness will be measured by the short physical performance battery (SPPB). 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-up
Title
Physical Function - Handgrip Strength
Description
Handgrip strength will be measured by a hand-held dynamometer. 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-up
Title
Physical Function - Timed Up and Go
Description
Physical function will be assessed with the timed-up-and-go (TUG) 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-up
Title
Physical Function - 6 minute walk test
Description
Physical function will be assessed with the 6 minute walk test (6MWT). 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-up
Title
Muscular Strength
Description
Muscular strength will be assessed with a 10 repetition maximum 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-up
Title
Patient reported outcomes - Fatigue
Description
Fatigue will be measured by the PROMIS cancer fatigue short form. 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-up
Title
Patient reported outcomes - Function
Description
Function will be measured by the Vulnerable Elders Survey (VES). 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-up
Title
Patient reported outcomes - Quality of Life
Description
Quality of life will be assessed by the functional assessment of cancer therapy - bone marrow transplant (FACT-BMT). 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-up
Title
Patient reported outcomes - Anxiety and Depression
Description
Anxiety and depression will be assessed by the Hospital Anxiety and Depression Scale (HADS). 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. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Time Frame
Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Title
Patient reported outcomes - Sleep
Description
Sleep will be assessed by the Pittsburg sleep quality index (PSQI). 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-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Norris, MS
Phone
857-215-0195
Email
maryk_norris@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-632-3800
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
PhD, MPH
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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

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