Feasibility of a Home Exercise Program to Manage Post-transplant Metabolic Syndrome

NCT ID: NCT04965142

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2024-07-30

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home Exercise Group

The home-based exercise group will be asked to exercise 3 to 5 times per week (≥ 150 minutes of aerobic exercises (i.e. walking, cycling, or treadmill) of at least moderate intensity) and to also complete resistance training (resistance bands or free weights) at least twice weekly over a 12-week period supervised by an exercise professional. The resistance training will be personalized, aiming for 6 to 10 exercises targeting the major muscle groups, progressing to 3 sets of 8 to 12 repetitions. Exercise prescriptions will be developed and monitored by an exercise professional with weekly follow-up meetings and supported with a web application (Physiotec) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials. Participants will receive one counselling session on healthy eating and physical activity at the start of the study along with an exercise manual.

Group Type: EXPERIMENTAL

Exercise Training

Intervention Type: BEHAVIORAL

The intervention group will be asked to complete aerobic exercises 3 to 5 times per week (≥ 150 minutes of at least moderate aerobic intensity) and resistance training at least twice a week over a 12-week period.

Control Group

Participants will receive one counselling session on healthy eating and physical activity at the start of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise Training

The intervention group will be asked to complete aerobic exercises 3 to 5 times per week (≥ 150 minutes of at least moderate aerobic intensity) and resistance training at least twice a week over a 12-week period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult lung and liver transplant recipients 12 to 18 months post-transplant
• Presence of 2 or more metabolic risk factors (hypertension, hyperlipidemia, diabetes, obesity)

Exclusion Criteria

• Active cardiovascular disease (recent heart attack, significant coronary artery disease on cardiac catheterization, heart failure, uncontrolled arrhythmias, chest pain, dizziness, or fainting in the last 3 months)
• Neuro-muscular disease or orthopedic limitations
• Physically active with ≥ 150 minutes/week of moderate-intensity aerobic physical activity
• Residing outside the province of Ontario

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian National Transplant Research Program

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dmitry Rozenberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network /University of Toronto

Locations

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Rozenberg D, Santa Mina D, Nourouzpour S, Camacho Perez E, Stewart BL, Wickerson L, Tsien C, Selzner N, Shore J, Aversa M, Woo M, Holdsworth S, Prevost K, Park J, Azhie A, Huszti E, McLeod E, Dales S, Bhat M. Feasibility of a Home-Based Exercise Program for Managing Posttransplant Metabolic Syndrome in Lung and Liver Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 23;11(3):e35700. doi: 10.2196/35700.

Reference Type: DERIVED

PMID: 35319467 (View on PubMed)

Other Identifiers

20-5185

Identifier Type: -

Identifier Source: org_study_id