Secondary Prevention of Coronary Heart Disease Clinical Trial
Official title:
Development of A Tai-Chi Program To Overcome Barriers To Cardiac Rehabilitation
| Verified date | August 2018 |
| Source | The Miriam Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | December 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 90 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Miriam Hospital | Providence | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| The Miriam Hospital | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) |
United States,
Salmoirago-Blotcher E, Wayne P, Bock BC, Dunsiger S, Wu WC, Stabile L, Yeh G. Design and methods of the Gentle Cardiac Rehabilitation Study--A behavioral study of tai chi exercise for patients not attending cardiac rehabilitation. Contemp Clin Trials. 2015 Jul;43:243-51. doi: 10.1016/j.cct.2015.06.020. Epub 2015 Jun 24. — View Citation
Salmoirago-Blotcher E, Wayne PM, Dunsiger S, Krol J, Breault C, Bock BC, Wu WC, Yeh GY. Tai Chi Is a Promising Exercise Option for Patients With Coronary Heart Disease Declining Cardiac Rehabilitation. J Am Heart Assoc. 2017 Oct 11;6(10). pii: e006603. do — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | ||
| Other | 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 | ||
| Other | change from baseline aerobic capacity (METs) | baseline and intervention completion | ||
| Other | 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 | ||
| Other | 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 | ||
| Other | 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 | ||
| Primary | retention rates | up to 9 months since enrollment | ||
| Primary | drop-out rates | up to 9 months since enrollment | ||
| Primary | tai chi class attendance rates | up to 6 months since enrollment | ||
| Primary | number of participants with severe and non severe adverse events | up to 9 months since enrollment | ||
| Primary | percentage of participants reporting intervention acceptability scores in highest quartile | 3, 6, and 9 months since enrollment | ||
| Secondary | 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 |