Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05236062
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2022-01-19
Brief Title:
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD the RESTART Trial
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTART
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 AR - Home-based aerobic and resistance exercise program
Attention control AC - Home-based stretching program
The names of the study interventions involved in this study are
Aerobic and resistance exercise AR - 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 AR 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 2AR1AC ratio to one of two groups
Aerobic and resistance exercise AR or
Attention control AC
The AR group will be asked to perform aerobic exercise which can improve cardiovascular heart and lung function and resistance exercise eg 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
This study consists of participants randomly assigned in 2AR1AC ratio to one of two groups
Aerobic and resistance exercise AR or
Attention control AC
The AR group will be asked to perform aerobic exercise which can improve cardiovascular heart and lung function and resistance exercise eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None