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临床试验 NCT05699642 (Mind2Move) 针对急性冠状动脉综合征，身体不活动目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Online Tai Chi Plus Fitbit After ACS (Mind2Move)
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临床试验NCT05699642 (Mind2Move)旨在研究其他，主要针对急性冠状动脉综合征，身体不活动。这是一项II期 (第二期) 干预性研究试验，目前试验状态为招募中。试验始于2024年8月27日，计划招募70名患者。该研究由Beth Israel Deaconess Medical Center主导，预计于2025年11月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年9月19日。
简要概括
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).
官方标题
Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors
疾病
急性冠状动脉综合征身体不活动其他研究标识符
- Mind2Move
- 2022P000891
NCT编号
实际开始日期
2024-08-27
最近更新发布
2024-09-19
预计完成日期
2025-11-30
计划入组人数
70
研究类型
干预性研究
试验分期 (阶段)
II期 (第二期)
试验状态
招募中
关键词
tai chi
fitness tracker
fitness tracker
主要目的
其他
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | Tai CHI + Wearable The tai chi intervention will be delivered remotely via Zoom Enterprise. Participants will access classes on a phone, tablet, laptop, or desktop computer. Participants will attend 3 classes/week (each lasting 60 min) during weeks 1-12, 2 classes/week during weeks 13-16, and then 1 class every other week during weeks 17-24. Classes include tai chi warm-up exercises, breathing exercises, review and practice of tai chi forms, and cool-down exercises. Participants will be asked to practice tai chi at home 3x per week during the 6 month intervention period using an instructional video provided to them. The Fitbit fitness tracker will be given to each participant along with instructions on how to use the tracker and the Fitbit app on their personal device. |
无干预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. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Recruitment rate | Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial. | Through study completion (an average of 3 years) |
Retention rate | Retention rate will be quantified by the proportion of subjects who remain in the study to complete our 9-month visit. | Through study completion (an average of 3 years) |
Intervention enjoyment | Intervention enjoyment will be assessed via qualitative interviews | 6 months |
Intervention adherence | Intervention adherence will be measured by collection of class attendance and home practice data. | Through study completion (an average of 3 years) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Physical activity | Physical activity will be measured using accelerometers (Actigraph model wGT3X-BT, LLC, Fort Walton Beach, FL). | Baseline, 6 and 9 months |
Systolic and diastolic blood pressure | Blood pressure will be measured using a Dinamap XL automated BP monitor according to current recommendations. | Baseline, 6 and 9 months |
Body weight | Body weight will be measured using an electronic scale. | Baseline, 6 and 9 months |
Height | Height will be measured using a tape measure. | Baseline |
Fasting glucose | Fasting glucose will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital. | Baseline, 6 and 9 months |
Lipid panel | Lipid panel will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital. | Baseline, 6 and 9 months |
hs-CRP | hs-CRP will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital. | Baseline, 6 and 9 months |
Quality of life assessed by SF-36 | Quality of life will be measured using a short version (8 items) of the Health Survey Short Form (SF-36). Scores range from 0-100, with a higher score indicating a higher quality of life. | Baseline, 6 and 9 months |
Intrinsic motivation | Intrinsic Motivation Inventory is a 22-item scale validated with four sub-scales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension. A higher score is better, with a scoring range of 22-154. | Baseline, 6 and 9 months |
Anxiety, Depression | Anxiety, Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity. | Baseline, 6 and 9 months |
Stress | Stress will be measured using the Perceived Stress Scale (PSS) - a 10 items survey with scores ranging from 0 to 40, and higher scores indicating greater stress burden. | Baseline, 6 and 9 months |
Mindful awareness | Mindful awareness will be assessed using the Five Facets of Mindfulness questionnaire (short form) a 15-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores ranges from 39-19, with a higher score being better. | Baseline, 6 and 9 months |
Exercise self-efficacy | Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale. This is a 9-item validated scale from McAuley's original barriers scale. Scores range form 9-28, with a higher score meaning more self-efficacy. | Baseline, 6 and 9 months |
Exercise capacity | Exercise capacity will be assessed via the 6 min walk test (6MWT), a simple, safe and reliable first-line assessment of functional status that correlates with peak oxygen uptake. | Baseline, 6 and 9 months |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- History of ACS (unstable angina, NSTEMI, and STEMI, defined per current AHA/ACC criteria);
- Age ≥ 18;
- 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
- 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)
Beth Israel Deaconess Medical CenterLifespan研究责任方
Gloria Y. Yeh, 主要研究者, Principal Investigator, Beth Israel Deaconess Medical Center
研究中心联系人
联系人: Daniel Litrownik, BA, 617-754-1423, [email protected]
1 位于 1 个国家/地区的研究中心
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
Research Assistant, 联系人, 617-754-1428, [email protected]
招募中