Secondary Prevention of Coronary Heart Disease
Conditions
Keywords
physical activity, coronary heart disease, exercise, affect, mind/body therapies, stress, psychological
Brief 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.
Detailed 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.
Interventions
BEHAVIORALPLUS
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
BEHAVIORALLITE
1 hour tai chi session 3 times a week (weeks 1-12)
Sponsors
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| retention rates | up to 9 months since enrollment |
| percentage of participants reporting intervention acceptability scores in highest quartile | 3, 6, and 9 months since enrollment |
| number of participants with severe and non severe adverse events | up to 9 months since enrollment |
| tai chi class attendance rates | up to 6 months since enrollment |
| drop-out rates | up to 9 months since enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Other
| Measure | Time frame |
|---|---|
| Mean between-group difference in within-participant change from baseline Short Form-36 quality of life scores over time (3, 6, and 9 months from enrollment) | baseline, 3,6, and 9 months |
| Mean between-group difference in within-participant change from baseline Multidimensional Scale of Perceived Social Support scores over time (3, 6, and 9 months from enrollment) | baseline, 3, 6, 9 months |
| Mean between-group difference in within-participant change from baseline Five Facets of Mindfulness (FFM) scores over time (3, 6, and 9 months from enrollment) | baseline, 3,6, and 9 months |
| Mean between-group difference in within-participant change from baseline Pittsburg Sleep Quality Index scores over time (3, 6, and 9 months from enrollment) | baseline, 3,6,9 months |
| change from baseline aerobic capacity (METs) | baseline and intervention completion |
| Mean between-group difference in within-participant change from baseline HADS depression scores over time (3, 6, and 9 months from enrollment) | baseline, 3, 6, and 9 months |
Countries
United States
Outcome results
None listed