Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04965142
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2021-06-17
Brief Title:
Feasibility of a Home Exercise Program to Manage Post-transplant Metabolic Syndrome
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Feasibility of a Home-Based Exercise Program in Lung and Liver Transplant Recipients for Management of Post-Transplant Metabolic Syndrome A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
Post-transplant metabolic syndrome PTMS affects about 50 liver transplant OLT and 25 lung transplant LTx recipients at 12-18 months post-transplant PTMS comprised of glucose intolerance obesity hypercholesterolemia and hypertension has been associated with increased risk for cardiovascular morbidity and long-term survival Exercise studies in the early post-transplant period have shown some benefits on PTMS risk factors with facility-based training but it remains unclear if exercise can be sustained in the home environment with sufficient adherence or training intensity to impact PTMS beyond the early post-transplant period Objectives 1 To evaluate the feasibility of a three-month individualized virtual home-based exercise training program in OLT and LTx recipients starting at 1 year post-transplant 2 To assess estimates of intervention efficacy on elements of PTMS insulin resistance exercise self-efficacy and health related quality of life HRQL Methods 20 OLT and 20 LTx recipients with 2 or more PTMS risk factors at 12-18 months post-transplant will be randomized to a home-based exercise program versus usual care The exercise group will undergo aerobic training 3 to 5 times per week with resistance training at least twice weekly over a 12-week period Exercises will be demonstrated by a qualified exercise professional during the first visit with weekly phone and video calls to guide exercise progression ease communication and promote exercise self-efficacy and adherence based on guiding behavioral principles As secondary measures PTMS insulin resistance body composition optional HRQL and assessment of self-efficacy will be assessed at baseline and 12-weeks
Detailed Description:
Both LTx and OLT recipients have several common risk factors for PTMS including significant weight gain immunosuppression and physical inactivity These risk factors have been shown to be partly reversible with an active lifestyle A home-based exercise program may prove to be an effective post-transplant intervention for improving the metabolic profile of transplant recipients
Primary objective To evaluate the feasibility recruitment rate program adherence attrition safety and participant satisfaction of a 12 week individualized virtual home-based aerobic and resistance training program in OLT and LTx recipients that are 12-18 months post-transplant Secondary objective To assess estimates of intervention efficacy on elements of PTMS insulin resistance exercise self-efficacy and HRQL
Hypotheses We hypothesize that it will be feasible to recruit both OLT and LTx recipients into a home-based exercise program with 70 adherence to the prescribed exercise dose Secondary Objective PTMS risk factors self-efficacy and HRQL will be improved with a home-based exercise program
The home-based exercise group will be asked to exercise 3 to 5 times per week 150 minutes of aerobic exercises at moderate intensity and to also complete resistance training resistance bands or free weights over a 12-week period with the guidance of a qualified exercise professional The control group will be counselled by a qualified exercise professional on the importance of accumulating at least 150 minutes of moderate physical activity during the first assessment at the beginning of the study Both groups will also receive physical activity trackers Fitbit exercise training or physical activity logs and a counselling session by the dietitian at the start of the study
A home-based exercise program may prove to be an effective post-transplant intervention for improving the metabolic profile of transplant recipients Characterizing the feasibility adherence and effect estimates of home-based exercise training constitutes the first key step in promoting a healthy lifestyle in transplant recipients and supporting the development of future trials aimed at reducing the morbidity associated with PTMS
Primary objective To evaluate the feasibility recruitment rate program adherence attrition safety and participant satisfaction of a 12 week individualized virtual home-based aerobic and resistance training program in OLT and LTx recipients that are 12-18 months post-transplant Secondary objective To assess estimates of intervention efficacy on elements of PTMS insulin resistance exercise self-efficacy and HRQL
Hypotheses We hypothesize that it will be feasible to recruit both OLT and LTx recipients into a home-based exercise program with 70 adherence to the prescribed exercise dose Secondary Objective PTMS risk factors self-efficacy and HRQL will be improved with a home-based exercise program
The home-based exercise group will be asked to exercise 3 to 5 times per week 150 minutes of aerobic exercises at moderate intensity and to also complete resistance training resistance bands or free weights over a 12-week period with the guidance of a qualified exercise professional The control group will be counselled by a qualified exercise professional on the importance of accumulating at least 150 minutes of moderate physical activity during the first assessment at the beginning of the study Both groups will also receive physical activity trackers Fitbit exercise training or physical activity logs and a counselling session by the dietitian at the start of the study
A home-based exercise program may prove to be an effective post-transplant intervention for improving the metabolic profile of transplant recipients Characterizing the feasibility adherence and effect estimates of home-based exercise training constitutes the first key step in promoting a healthy lifestyle in transplant recipients and supporting the development of future trials aimed at reducing the morbidity associated with PTMS
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