Tai Chi and Fitbit Program for Survivors of Acute Coronary Syndrome

Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors

This study is testing if a 6-month tai chi program with a fitness tracker can help people who have survived a heart condition be more active and improve their health compared to just getting regular care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05699642 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a 6-month group tai chi program combined with a wearable fitness tracker to encourage physical activity among survivors of acute coronary syndrome (ACS). Participants will be randomly assigned to either the tai chi program with the fitness tracker and enhanced usual care or to enhanced usual care alone. The study will assess feasibility and acceptability, as well as various patient-centered outcomes related to physical activity and cardiometabolic health. Assessments will occur at baseline, 6 months, and 9 months to evaluate changes in physical activity levels and overall health metrics.

Who should consider this trial

Good fit: Ideal candidates include physically inactive adults aged 18 and older with a history of acute coronary syndrome who have physician clearance for low to moderate intensity exercise.

Not a fit: Patients with uncontrolled hypertension, significant arrhythmias, or recent pericarditis may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve physical activity levels and overall health outcomes for ACS survivors.

How similar studies have performed: Previous studies have shown positive outcomes with tai chi and physical activity interventions in similar populations, suggesting potential for success in this approach.

Eligibility criteria

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)

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Daniel Litrownik, BA

Conditions Acute Coronary Syndrome; Physical Inactivity; tai chi; fitness tracker