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临床试验/NCT02165254
NCT02165254已完成不适用

Development of A Tai-Chi Program To Overcome Barriers To Cardiac Rehabilitation

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
retention rates

研究概览

简要总结

The purpose of this study is to develop a tai-chi based exercise program designed for patients who recently had a heart attack and do not wish, or are unable, to attend traditional cardiac rehabilitation.

详细描述

We will estimate the feasibility, acceptability and safety of two different doses of the Tai Chi intervention (primary outcome). 60 patients (30 per dose arm) will be randomly assigned to a standard dose of Tai Chi (the dose used by our group in large studies of heart failure patients) or to a high dose matching the recommended frequency and duration of exercise classes in current CRs. Acceptability assessments will include surveys and focus groups to formally assess the impact of Tai Chi on facilitators and barriers to CRs in this population. We will also obtain estimates of effect sizes of each dose on accelerometry measured physical activity and on the proportion of patients achieving the current American Heart Association (AHA) recommendation for physical activity (secondary outcome). Additional outcomes will be cardiac fitness, quality of life, body weight, and sleep. In addition, we will gather exploratory information on possible mechanisms by which Tai Chi training may affect physical activity. We will collect information on possible mediators such as exercise self-efficacy, perceived social support, and depression. In addition, since Tai Chi training is associated with meditative practices aimed at increasing present-moment awareness, we will gather information on mindfulness levels. Measurements will be conducted at baseline, 3-, 6-, and 9 months after enrollment.

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
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to understand and speak English
  • Physically inactive
  • Ability to understand the study procedures and willingness to commit to the demands of the study protocol

排除标准

  • Inability or unwillingness to give informed consent
  • Planning to move out of the area within the study period
  • Unstable angina
  • Blood pressure >200/110 or symptomatic orthostatic blood pressure decrease>20 mmHg
  • Uncontrolled atrial or ventricular arrhythmias; 3rd degree Atrio-Ventricular block
  • Pericarditis or myocarditis
  • Recent embolism/thrombophlebitis
  • Abnormal stress test without study cardiologist's clearance
  • Medical conditions likely to limit lifespan
  • NYHA functional class IV
  • Signs of cognitive impairment (BOMC >10)
  • Orthopedic problems prohibiting Tai Chi practice
  • Ongoing Tai Chi or other mind-body training
  • Current enrollment in a CR program
  • Severe depression (HADS scores>14)
  • Current drug or alcohol use or dependence that would interfere with adherence to study requirements.

研究组 & 干预措施

high dose tai chi intervention

Other

干预措施: PLUS (Behavioral)

standard dose tai chi intervention

Other

干预措施: LITE (Behavioral)

结局指标

主要结局

retention rates

时间窗: up to 9 months since enrollment

tai chi class attendance rates

时间窗: up to 6 months since enrollment

number of participants with severe and non severe adverse events

时间窗: up to 9 months since enrollment

percentage of participants reporting intervention acceptability scores in highest quartile

时间窗: 3, 6, and 9 months since enrollment

drop-out rates

时间窗: up to 9 months since enrollment

次要结局

  • Mean between-group difference in within-participant change from baseline physical activity (accelerometry counts) over time (3, 6, and 9 months from enrollment)(baseline, 3, 6, 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Salmoirago-Blotcher

Assistant Professor of Medicine

The Miriam Hospital

研究点 (2)

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