Overview

This trial is active, not recruiting.

Condition secondary prevention of coronary heart disease
Treatments plus, lite
Sponsor The Miriam Hospital
Collaborator National Institutes of Health (NIH)
Start date October 2014
End date August 2016
Trial size 33 participants
Trial identifier NCT02165254, R34AT007569

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
plus
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
(Other)
lite
1 hour tai chi session 3 times a week (weeks 1-12)

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 21 years up to 90 years old.

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.

Additional Information

Official title Development of A Tai-Chi Program To Overcome Barriers To Cardiac Rehabilitation
Principal investigator Elena Salmoirago-Blotcher, PhD, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by The Miriam Hospital.