The Gentle Cardiac Rehabilitation Study

Lifespan

Status: Completed

Conditions: Secondary Prevention of Coronary Heart Disease

Treatments: Behavioral: PLUS; Behavioral: LITE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02165254

R34AT007569 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able to understand and speak English
2. Age ≥21
3. Physically inactive
4. Ability to understand the study procedures and willingness to commit to the demands of the study protocol

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

high dose tai chi intervention

Other group

Treatment:

Behavioral: PLUS

standard dose tai chi intervention

Other group

Treatment:

Behavioral: LITE