Clinical trial NCT02165254: The Gentle Cardiac Rehabilitation Study
Official title: Development of A Tai-Chi Program To Overcome Barriers To Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Prevention of Coronary Heart Disease
Keywords: physical activity
coronary heart disease
exercise
affect
mind/body therapies
stress, psychological
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-06-17
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: retention rates
timeFrame: up to 9 months since enrollment
measure: drop-out rates
timeFrame: up to 9 months since enrollment
measure: tai chi class attendance rates
timeFrame: up to 6 months since enrollment
measure: number of participants with severe and non severe adverse events
timeFrame: up to 9 months since enrollment
measure: percentage of participants reporting intervention acceptability scores in highest quartile
timeFrame: 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)
timeFrame: baseline, 3, 6, 9 months
Other outcomes:
measure: 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)
timeFrame: baseline, 3,6, and 9 months
measure: Mean between-group difference in within-participant change from baseline HADS depression scores over time (3, 6, and 9 months from enrollment)
timeFrame: baseline, 3, 6, and 9 months
measure: change from baseline aerobic capacity (METs)
timeFrame: baseline and intervention completion
measure: Mean between-group difference in within-participant change from baseline Pittsburg Sleep Quality Index scores over time (3, 6, and 9 months from enrollment)
timeFrame: baseline, 3,6,9 months
measure: 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)
timeFrame: baseline, 3,6, and 9 months
measure: 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)
timeFrame: baseline, 3, 6, 9 months
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital & Warren Alpert Medical School at Brown University
name: Elena Salmoirago-Blotcher, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):e006603. doi: 10.1161/JAHA.117.006603.