Clinical trial NCT04965142: Feasibility of a Home Exercise Program to Manage Post-transplant Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Lung Transplant Recipients
Liver Transplant Recipients
Exercise Training
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian National Transplant Research Program
name: University of Toronto
First posted: 2021-07-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Lung and liver transplant recipients will be randomized to home exercise group versus usual care group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment
timeFrame: When recruitment is complete (approximately 18 months after study initiation)
measure: Adherence to Exercise Training
timeFrame: Over a 12 week period
measure: Study Retention
timeFrame: Over a 12 week period
measure: Adverse Events During Exercise Training (Safety and Tolerability)
timeFrame: Over a 12 week period
measure: Participant Satisfaction with Exercise Training and Study Participation (Exercise Group)
timeFrame: Change over the study period assessed at weeks 2, 6, and 12
measure: Participant Satisfaction with Study Participation (Control Group)
timeFrame: 12 weeks from baseline assessment
Secondary outcomes:
measure: Total Cholesterol
timeFrame: Change from baseline at 12 weeks
measure: Triglycerides
timeFrame: Change from baseline at 12 weeks
measure: High Density Lipoprotein
timeFrame: Change from baseline at 12 weeks
measure: Low Density Lipoprotein
timeFrame: Change from baseline at 12 weeks
measure: Fasting Blood Glucose Levels
timeFrame: Change from baseline at 12 weeks
measure: Hemoglobin A1C
timeFrame: Change from baseline at 12 weeks
measure: Insulin Resistance
timeFrame: Change from baseline at 12 weeks
measure: C-peptide Levels
timeFrame: Change from baseline at 12 weeks
measure: C-reactive Protein Levels
timeFrame: Change from baseline at 12 weeks
measure: Health Related Quality of Life assessed with the Short-Form 36 Health Survey
timeFrame: Change from baseline at 12 weeks
measure: Physical Function assessed with the Short-Physical Performance Battery
timeFrame: Change from baseline at 12 weeks
measure: Physical Activity Questionnaire
timeFrame: Change from baseline at 12 weeks
measure: Self-Efficacy with Exercise Training (Exercise Group)
timeFrame: Change from baseline at 2, 6, and 12 weeks
measure: Self-Efficacy with Exercise Training (Control Group)
timeFrame: Change from baseline at 12 weeks
measure: Nutritional Questionnaire
timeFrame: Change from baseline at 12 weeks
measure: Lifestyle and Environmental Questionnaire
timeFrame: Baseline
Other outcomes:
measure: Liver Fibrosis
timeFrame: Change from baseline at 12 weeks
measure: Fat Free Mass Index
timeFrame: Change from baseline at 12 weeks
measure: Body Fat Mass Index
timeFrame: Change from baseline at 12 weeks
measure: Electrocardiogram
timeFrame: Baseline
Locations:
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network /University of Toronto
name: Dmitry Rozenberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.