The Gentle Cardiac Rehabilitation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Secondary Prevention of Coronary Heart Disease

Intervention / Treatment
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* Behavioral: PLUS
* Behavioral: LITE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and speak English Age ≥21 Physically inactive Ability to understand the study procedures and willingness to commit to the demands of the study protocol Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: high dose tai chi intervention<br> | Behavioral: PLUS<br>* 1 hour tai chi session 3 times a week (weeks 1-12), to twice a week (week 13-16), and every other week (week 17-26) for a total of 24 weeks<br>|
| Other: standard dose tai chi intervention<br> | Behavioral: LITE<br>* 1 hour tai chi session 3 times a week (weeks 1-12)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention rates |  | up to 9 months since enrollment | 
| drop-out rates |  | up to 9 months since enrollment | 
| tai chi class attendance rates |  | up to 6 months since enrollment | 
| number of participants with severe and non severe adverse events |  | up to 9 months since enrollment | 
| percentage of participants reporting intervention acceptability scores in highest quartile |  | 3, 6, and 9 months since enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean between-group difference in within-participant change from baseline physical activity (accelerometry counts) over time (3, 6, and 9 months from enrollment) | To estimate mean between-doses differences in physical activity (and other continuous secondary outcomes listed below), we will estimate multivariate linear mixed models for within-participant change since baseline as a function of dose group (high or low), time point (3, 6, and 9 months from enrollment, treated as a categorical variable to allow for non-linear trajectories), and their interaction. A statistically significant interaction indicates that between-group differences vary across time points. | baseline, 3, 6, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, coronary heart disease, exercise, affect, mind/body therapies, stress, psychological