Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This projects studies the role of tai chi exercise and wearable fitness trackers to promote physical activity in acute coronary syndrome (ACS) survivors.
详细描述
This is a two-site randomized controlled trial taking place at Beth Israel Deaconess Medical Center in Boston, MA and The Miriam Hospital in Providence, RI. Seventy (n=70) physically inactive ACS survivors will be randomized to either a 6-month group tai chi program (remotely-delivered classes on Zoom) integrated with a wearable self-monitoring/feedback device plus enhanced usual care (EUC), or to EUC alone. EUC will include usual care provided by participants' providers integrated with printed CHD risk factor education materials. Assessments will be conducted in-person at baseline, 6 months (end of treatment), and 9 months. Our primary outcomes will be focused on study feasibility and acceptability. Secondary outcomes include the following patient-centered outcomes: objectively measured (via accelerometry) moderate-vigorous physical activity, light physical activity, sedentary time, cognitive-behavioral constructs (exercise self-efficacy, intrinsic motivation, depression, stress, HRQL), and cardiometabolic measures (exercise capacity, body weight, lipid profile, blood pressure, fasting plasma glucose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •History of ACS (unstable angina, NSTEMI, and STEMI, defined per current AHA/ACC criteria);
- •Being physically inactive (i.e., < 150 min/week of moderate-intensity aerobic PA);
- •Absence of contraindications to physical exercise per the participant's provider evaluation;
- •Access to a digital device with internet connection;
- •Having an active email account and ability to check email at least weekly;
- •Physician clearance to participate in low-moderate intensity exercise (tai chi), including a statement that there is no contraindication to exercise based on post-ACS stress test and other factors, as appropriate;
- •English speaking
排除标准
- •Inability or unwillingness to give informed consent;
- •Blood pressure >200/110 or orthostatic systolic blood pressure decrease >20 mmHg at the baseline visit;
- •Uncontrolled/untreated atrial or ventricular arrhythmias or 3rd degree AV block;
- •Within 3 months of a diagnosis of pericarditis or myocarditis;
- •Medical conditions likely to limit lifespan to less than one year;
- •New York Heart Association (NYHA) functional class IV;
- •Severe cognitive impairment (BOMC >10);139
- •Orthopedic problems prohibiting TC practice;
- •Ongoing TC or other mind-body training (i.e., meditation, TC, or yoga) at least weekly;
- •Current enrollment in cardiac rehabilitation;
- •Untreated severe depression (PHQ>=20);
- •Conditions likely to affect study compliance (i.e., moving out of study area, substance use, ongoing untreated psychosis);
- •Symptoms of unstable cardiovascular disease (e.g., shortness of breath or chest pain at rest and/or Canadian Cardiovascular Society Angina Class III-IV)
研究组 & 干预措施
Enhanced usual care
Printed educational materials based on existing resources (e.g., AHA; Centers for Disease Control and Prevention) will be shared with subjects in this group.
Tai chi + wearable
48 virtual tai chi classes on Zoom over 6 months plus assigned home practice of tai chi 3x a week plus daily use of a Fitbit fitness tracker will be required for this group.
干预措施: Tai chi + wearable (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Through study completion (an average of 3 years)
Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
Retention rate
时间窗: Through study completion (an average of 3 years)
Retention rate will be quantified by the proportion of subjects who remain in the study to complete our 9-month visit.
Intervention adherence
时间窗: Through study completion (an average of 3 years)
Intervention adherence will be measured by collection of class attendance and home practice data.
Intervention enjoyment
时间窗: 6 months
Intervention enjoyment will be assessed via qualitative interviews
次要结局
- Lipid panel(Baseline, 6 and 9 months)
- hs-CRP(Baseline, 6 and 9 months)
- Systolic and diastolic blood pressure(Baseline, 6 and 9 months)
- Height(Baseline)
- Intrinsic motivation(Baseline, 6 and 9 months)
- Anxiety, Depression(Baseline, 6 and 9 months)
- Stress(Baseline, 6 and 9 months)
- Mindful awareness(Baseline, 6 and 9 months)
- Exercise self-efficacy(Baseline, 6 and 9 months)
- Exercise capacity(Baseline, 6 and 9 months)
- Physical activity(Baseline, 6 and 9 months)
- Fasting glucose(Baseline, 6 and 9 months)
- Body weight(Baseline, 6 and 9 months)
- Quality of life assessed by SF-36(Baseline, 6 and 9 months)
研究者
Gloria Y. Yeh
Principal Investigator
Beth Israel Deaconess Medical Center