Online Tai Chi Plus Fitbit After ACS

Phase 2

Not yet recruiting

• Conditions: Physical Inactivity; Acute Coronary Syndrome
• Interventions: Behavioral: Tai chi + wearable

• Registration Number: NCT05699642
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

This projects studies the role of tai chi exercise and wearable fitness trackers to promote physical activity in acute coronary syndrome (ACS) survivors.

Detailed Description

This is a two-site randomized controlled trial taking place at Beth Israel Deaconess Medical Center in Boston, MA and The Miriam Hospital in Providence, RI. Seventy (n=70) physically inactive ACS survivors will be randomized to either a 6-month group tai chi program (remotely-delivered classes on Zoom) integrated with a wearable self-monitoring/feedback device plus enhanced usual care (EUC), or to EUC alone. EUC will include usual care provided by participants' providers integrated with printed CHD risk factor education materials. Assessments will be conducted in-person at baseline, 6 months (end of treatment), and 9 months. Our primary outcomes will be focused on study feasibility and acceptability. Secondary outcomes include the following patient-centered outcomes: objectively measured (via accelerometry) moderate-vigorous physical activity, light physical activity, sedentary time, cognitive-behavioral constructs (exercise self-efficacy, intrinsic motivation, depression, stress, HRQL), and cardiometabolic measures (exercise capacity, body weight, lipid profile, blood pressure, fasting plasma glucose).

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Study Start: 2024-04-15
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. History of ACS (unstable angina, NSTEMI, and STEMI, defined per current AHA/ACC criteria);
2. Age ≥ 18;
3. Being physically inactive (i.e., < 150 min/week of moderate-intensity aerobic PA);
4. Absence of contraindications to physical exercise per the participant's provider evaluation;
5. Access to a digital device with internet connection;
6. Having an active email account and ability to check email at least weekly;
7. Physician clearance to participate in low-moderate intensity exercise (tai chi), including a statement that there is no contraindication to exercise based on post-ACS stress test and other factors, as appropriate;
8. English speaking

Exclusion Criteria

1. Inability or unwillingness to give informed consent;
2. Blood pressure >200/110 or orthostatic systolic blood pressure decrease >20 mmHg at the baseline visit;
3. Uncontrolled/untreated atrial or ventricular arrhythmias or 3rd degree AV block;
4. Within 3 months of a diagnosis of pericarditis or myocarditis;
5. Medical conditions likely to limit lifespan to less than one year;
6. New York Heart Association (NYHA) functional class IV;
7. Severe cognitive impairment (BOMC >10);139
8. Orthopedic problems prohibiting TC practice;
9. Ongoing TC or other mind-body training (i.e., meditation, TC, or yoga) at least weekly;
10. Current enrollment in cardiac rehabilitation;
11. Untreated severe depression (PHQ>=20);
12. Conditions likely to affect study compliance (i.e., moving out of study area, substance use, ongoing untreated psychosis);
13. Symptoms of unstable cardiovascular disease (e.g., shortness of breath or chest pain at rest and/or Canadian Cardiovascular Society Angina Class III-IV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai chi + wearable	Tai chi + wearable	48 virtual tai chi classes on Zoom over 6 months plus assigned home practice of tai chi 3x a week plus daily use of a Fitbit fitness tracker will be required for this group.

Primary Outcome Measures

Name	Time	Method
Recruitment rate	Through study completion (an average of 3 years)	Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
Retention rate	Through study completion (an average of 3 years)	Retention rate will be quantified by the proportion of subjects who remain in the study to complete our 9-month visit.
Intervention enjoyment	6 months	Intervention enjoyment will be assessed via qualitative interviews
Intervention adherence	Through study completion (an average of 3 years)	Intervention adherence will be measured by collection of class attendance and home practice data.

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure	Baseline, 6 and 9 months	Blood pressure will be measured using a Dinamap XL automated BP monitor according to current recommendations.
Height	Baseline	Height will be measured using a tape measure.
Intrinsic motivation	Baseline, 6 and 9 months	Intrinsic Motivation Inventory is a 22-item scale validated with four sub-scales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension. A higher score is better, with a scoring range of 22-154.
Anxiety, Depression	Baseline, 6 and 9 months	Anxiety, Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity.
Stress	Baseline, 6 and 9 months	Stress will be measured using the Perceived Stress Scale (PSS) - a 10 items survey with scores ranging from 0 to 40, and higher scores indicating greater stress burden.
Mindful awareness	Baseline, 6 and 9 months	Mindful awareness will be assessed using the Five Facets of Mindfulness questionnaire (short form) a 15-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores ranges from 39-19, with a higher score being better.
Exercise self-efficacy	Baseline, 6 and 9 months	Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale. This is a 9-item validated scale from McAuley's original barriers scale. Scores range form 9-28, with a higher score meaning more self-efficacy.
Exercise capacity	Baseline, 6 and 9 months	Exercise capacity will be assessed via the 6 min walk test (6MWT), a simple, safe and reliable first-line assessment of functional status that correlates with peak oxygen uptake.
Physical activity	Baseline, 6 and 9 months	Physical activity will be measured using accelerometers (Actigraph model wGT3X-BT, LLC, Fort Walton Beach, FL).
Body weight	Baseline, 6 and 9 months	Body weight will be measured using an electronic scale.
Fasting glucose	Baseline, 6 and 9 months	Fasting glucose will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
Lipid panel	Baseline, 6 and 9 months	Lipid panel will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
hs-CRP	Baseline, 6 and 9 months	hs-CRP will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
Quality of life assessed by SF-36	Baseline, 6 and 9 months	Quality of life will be measured using a short version (8 items) of the Health Survey Short Form (SF-36). Scores range from 0-100, with a higher score indicating a higher quality of life.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States