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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Adverse Events During Exercise Training (Safety and Tolerability)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult lung and liver transplant recipients 12 to 18 months post-transplant
- •Presence of 2 or more metabolic risk factors (hypertension, hyperlipidemia, diabetes, obesity)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exercise Training (Behavioral)
Control Group
Participants will receive one counselling session on healthy eating and physical activity at the start of the study.
结局指标
主要结局
Adverse Events During Exercise Training (Safety and Tolerability)
时间窗: Over a 12 week period
Adverse events with exercise training will be assessed throughout the study period.
Participant Satisfaction with Exercise Training and Study Participation (Exercise Group)
时间窗: Change over the study period assessed at weeks 2, 6, and 12
Multiple choice and free form questionnaire assessing the participants' satisfaction with the home exercise program and study intervention.
Participant Satisfaction with Study Participation (Control Group)
时间窗: 12 weeks from baseline assessment
Multiple choice and free form questionnaire assessing participants' satisfaction with the study intervention.
Study Retention
时间窗: Over a 12 week period
Retention will be assessed by measuring attrition throughout the intervention period.
Recruitment
时间窗: When recruitment is complete (approximately 18 months after study initiation)
We will measure recruitment-success percentage and will record reasons for non-participation.
Adherence to Exercise Training
时间窗: Over a 12 week period
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.
次要结局
- Nutritional Questionnaire(Change from baseline at 12 weeks)
- Total Cholesterol(Change from baseline at 12 weeks)
- Triglycerides(Change from baseline at 12 weeks)
- Low Density Lipoprotein(Change from baseline at 12 weeks)
- Hemoglobin A1C(Change from baseline at 12 weeks)
- Insulin Resistance(Change from baseline at 12 weeks)
- C-peptide Levels(Change from baseline at 12 weeks)
- Fasting Blood Glucose Levels(Change from baseline at 12 weeks)
- C-reactive Protein Levels(Change from baseline at 12 weeks)
- Health Related Quality of Life assessed with the Short-Form 36 Health Survey(Change from baseline at 12 weeks)
- Physical Function assessed with the Short-Physical Performance Battery(Change from baseline at 12 weeks)
- Physical Activity Questionnaire(Change from baseline at 12 weeks)
- Self-Efficacy with Exercise Training (Control Group)(Change from baseline at 12 weeks)
- Lifestyle and Environmental Questionnaire(Baseline)
- High Density Lipoprotein(Change from baseline at 12 weeks)
- Self-Efficacy with Exercise Training (Exercise Group)(Change from baseline at 2, 6, and 12 weeks)