Time Restricted Eating and Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Adherence to the daily ≥16-hour fast for the 16-weeks of the cardiac rehabilitation program.
研究概览
简要总结
This study will use a form of intermittent fasting called time-restricted eating (TRE) where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE could be an effective addition to cardiac rehabilitation as it has demonstrated cardiovascular health benefits and potential for synergy when combined with exercise training. This study will determine if TRE is a feasible and safe nutrition intervention during cardiac rehabilitation and if TRE improves the health benefits of cardiac rehabilitation compared to cardiac rehabilitation alone.
详细描述
HYPOTHESIS
- Cardiac rehabilitation and TRE will be feasible in terms of adherence to a 16-hour daily fast (≥70%, which would represent 5/7 days/week) and safe (no excess symptoms or adverse events)
- Cardiac rehabilitation and TRE will provide added cardiovascular health benefits (improved VO2peak, reduced fat mass) compared to cardiac rehabilitation alone.
JUSTIFICATION: Past animal and human clinical trials have demonstrated TRE to be beneficial in realigning circadian rhythm, improve coronary artery disease (CAD) and peripheral artery disease (PAD) through the reduction in calorie intake, and promote cell signalling and repair pathways during the fasting period. TRE has not been tested in patients with CAD or other heart diseases but has shown to improve comorbid conditions (diabetes and hypertension) and improve metabolic profiles (blood pressure, hemoglobin A1c, fasting glucose, insulin sensitivity, and lipid profiles. Additionally, TRE when combined with exercise, such as in cardiac rehabilitation programs, improves VO2 peak and reduces fat mass compared to exercise alone. The proposed study will deliver a TRE intervention in combination with the cardiac rehabilitation program and is expected to be feasible, safe, and improve outcomes of cardiac rehabilitation.
OBJECTIVES: The primary aim of this study is to evaluate the feasibility (adherence) and safety (adverse events) of TRE in combination with cardiac rehabilitation.
The secondary aim is to assess the efficacy of the intervention on:
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
- Single (Outcomes Assessor)
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
- •Men and women who are referred and eligible for either the outpatient cardiac rehabilitation program for coronary artery disease or peripheral vascular disease
- •willing to accept random assignment and complete the study assessments
- •Equal numbers of men and women will be recruited
排除标准
- •Inability to complete the consent form and communicate in English
- •Self-reported history of an eating disorder
- •Current or recent (1 year) pregnancy or breast feeding
- •Body mass index <18.5 kg/m^2 or clinical signs of cachexia
- •Contraindications or inability to perform cardiopulmonary exercise testing
- •Type 1 diabetes
- •Type 2 diabetes that requires exogenous insulin
- •Working night or rotating shifts
- •Eating window <12 hours or consistently eating less than 3 meals/day in the past 3 months
研究组 & 干预措施
Standard cardiac rehabilitation
The 16-week program consists of physician-directed risk factor management, an individualized aerobic and resistance exercise prescription, and virtual education on disease management and lifestyle behaviors (including exercise safety, stress management, and heart-healthy nutrition), and an assessment with a registered dietitian and individualized recommendations for a heart-healthy diet. Additionally, selected patients with identified issues such as depression, anxiety, trouble sleeping, anger and social and emotional issues will receive one-on-one counselling with a psychologist or social worker.
干预措施: Standard cardiac rehabilitation (Behavioral)
Standard cardiac rehabilitation + TRE
Participants in this group will receive the same standard assessment and individualized recommendations as the comparator group, but will also be counselled to restrict their eating to between 11 am and 7 pm during the program starting the evening of the consultation. They will also be advised to perform their home-based exercise sessions during the fasting period in the morning.
干预措施: Time-Restricted Eating (Behavioral)
Standard cardiac rehabilitation + TRE
Participants in this group will receive the same standard assessment and individualized recommendations as the comparator group, but will also be counselled to restrict their eating to between 11 am and 7 pm during the program starting the evening of the consultation. They will also be advised to perform their home-based exercise sessions during the fasting period in the morning.
干预措施: Standard cardiac rehabilitation (Behavioral)
结局指标
主要结局
Adherence to the daily ≥16-hour fast for the 16-weeks of the cardiac rehabilitation program.
时间窗: Averaged over the 16 weeks of the intervention
Assessed daily through a custom twice daily automated text message (or email) program, or written logs for those without cell phones. Adherence will be measured as a % of days with ≥16-hour fast.
Cardiorespiratory fitness as measured by peak volume of oxygen consumption (VO2peak)
时间窗: 16 weeks
Assessed by an incremental, to-maximum cardiopulmonary treadmill exercise test.
Fat mass
时间窗: 16 weeks
Assessed by dual absorptiometry x-ray (DXA) scan.
次要结局
- Hemoglobin A1c(16 weeks)
- Seattle Angina Questionnaire score(16 weeks)
- Fat-free mass(16 weeks)
- Fasted blood glucose(16 weeks)
- Metabolic syndrome(16 weeks)
- Symptoms from TRE(16 weeks)
- Blood pressure(16 weeks)
- Adverse events(1-year)
- Lipid profile(16 weeks)
- Waist circumference(16 weeks)
- Health-related quality of life measured by the RAND-36 Physical Component Summary(16 weeks)
研究者
Amy Kirkham
Assistant Professor
University of Toronto