The Gentle Cardiac Rehabilitation Study



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 90
Updated:8/18/2018
Start Date:October 2014
End Date:December 2016

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

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.

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.

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.
We found this trial at
1
site
164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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mi
from
Providence, RI
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