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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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.
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Recruitment
We will measure recruitment-success percentage and will record reasons for non-participation.
Time frame: When recruitment is complete (approximately 18 months after study initiation)
Adherence to Exercise Training
Adherence to the home-based exercise program (aerobic and resistance) will be measured through an exercise diary completed by participants and reviewed through weekly communication.
Time frame: Over a 12 week period
Study Retention
Retention will be assessed by measuring attrition throughout the intervention period.
Time frame: Over a 12 week period
Adverse Events During Exercise Training (Safety and Tolerability)
Adverse events with exercise training will be assessed throughout the study period.
Time frame: Over a 12 week period
Participant Satisfaction with Exercise Training and Study Participation (Exercise Group)
Multiple choice and free form questionnaire assessing the participants' satisfaction with the home exercise program and study intervention.
Time frame: Change over the study period assessed at weeks 2, 6, and 12
Participant Satisfaction with Study Participation (Control Group)
Multiple choice and free form questionnaire assessing participants' satisfaction with the study intervention.
Time frame: 12 weeks from baseline assessment
Total Cholesterol
Participants will undergo fasting blood work to assess total cholesterol levels.
Time frame: Change from baseline at 12 weeks
Triglycerides
Participants will undergo fasting blood work to assess triglyceride levels.
Time frame: Change from baseline at 12 weeks
High Density Lipoprotein
Participants will undergo fasting blood work to assess high density lipoprotein.
Time frame: Change from baseline at 12 weeks
Low Density Lipoprotein
Participants will undergo fasting blood work to assess low density lipoprotein.
Time frame: Change from baseline at 12 weeks
Fasting Blood Glucose Levels
Fasting blood glucose levels will be ascertained from blood testing results.
Time frame: Change from baseline at 12 weeks
Hemoglobin A1C
Hemoglobin A1C results will be assessed from bloodwork, which allows assessment of the average level of blood sugar over the previous 3 months.
Time frame: Change from baseline at 12 weeks
Insulin Resistance
Insulin resistance will be captured using the Homeostatic Model Assessment of Insulin Resistance protocol (fasting insulin \* fasting blood glucose).
Time frame: Change from baseline at 12 weeks
C-peptide Levels
C-peptide levels will be analyzed via blood testing in a subset of participants on exogenous insulin therapy.
Time frame: Change from baseline at 12 weeks
C-reactive Protein Levels
C-reactive protein levels will be ascertained from blood testing results.
Time frame: Change from baseline at 12 weeks
Health Related Quality of Life assessed with the Short-Form 36 Health Survey
The Short-Form 36 Health Survey (SF-36) will be used to assess general health-related quality of life. The SF-36 consists of eight scaled scores (total score ranging from 0 to 100), with lower scores representing lower health-related quality of life.
Time frame: Change from baseline at 12 weeks
Physical Function assessed with the Short-Physical Performance Battery
The Short-Physical Performance Battery will assess participants' balance, gait speed, and ability to rise from a chair 5 times.
Time frame: Change from baseline at 12 weeks
Physical Activity Questionnaire
The Physical Activity Scale for the Elderly (PASE) is a short survey created to assess physical activity levels in older adults. The PASE uses frequency, duration, and intensity level of physical activities over one week to assign a score (ranging from 0 to 793), with higher scores indicating greater levels of physical activity.
Time frame: Change from baseline at 12 weeks
Self-Efficacy with Exercise Training (Exercise Group)
The Exercise Self-Efficacy Scale (ESES) is a 4-point rating Likert scale in which participants rate their confidence with carrying out their regular physical activities and exercise. The ESES uses a 100-point percentage scale, ranging from 0% (not at all confident) to 100% (highly confident). Higher scores represent higher self-efficacy to exercise.
Time frame: Change from baseline at 2, 6, and 12 weeks
Self-Efficacy with Exercise Training (Control Group)
The Exercise Self-Efficacy Scale (ESES) is a 4-point rating Likert scale in which participants rate their confidence with carrying out their regular physical activities and exercise. The ESES uses a 100-point percentage scale, ranging from 0% (not at all confident) to 100% (highly confident). Higher scores represent higher self-efficacy to exercise.
Time frame: Change from baseline at 12 weeks
Nutritional Questionnaire
The Rapid Eating and Activity Assessment for Patients (REAP) survey assesses nutrient intake and helps with lifestyle counseling. The survey contains 27 questions with higher scores indicating higher diet quality (score range, 27 to 81).
Time frame: Change from baseline at 12 weeks
Lifestyle and Environmental Questionnaire
The Lifestyle and Environmental Questionnaire is a questionnaire developed by our research team to assess familiarity and comfort levels surrounding technology, barriers to exercise and assess previous experience with exercise. It is composed of 10 multiple-choice questions with each question assessed independently.
Time frame: Baseline
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