Online Tai Chi Plus Fitbit After ACS

Phase 2Active Not RecruitingNCT05699642

Beth Israel Deaconess Medical Center70 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Acute Coronary Syndrome Physical Inactivity

Interventions

Tai chi + wearableBEHAVIORAL

The tai chi intervention will be delivered remotely via Zoom Enterprise. Participants will access classes on a phone, tablet, laptop, or desktop computer. Participants will attend 3 classes/week (each lasting 60 min) during weeks 1-12, 2 classes/week during weeks 13-16, and then 1 class every other week during weeks 17-24. Classes include tai chi warm-up exercises, breathing exercises, review and practice of tai chi forms, and cool-down exercises. Participants will be asked to practice tai chi at home 3x per week during the 6 month intervention period using an instructional video provided to them. The Fitbit fitness tracker will be given to each participant along with instructions on how to use the tracker and the Fitbit app on their personal device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Recruitment rate

Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.

Time frame: Through study completion (an average of 3 years)

Retention rate

Retention rate will be quantified by the proportion of subjects who remain in the study to complete our 9-month visit.

Time frame: Through study completion (an average of 3 years)

Intervention enjoyment

Intervention enjoyment will be assessed via qualitative interviews

Time frame: 6 months

Intervention adherence

Intervention adherence will be measured by collection of class attendance and home practice data.

Time frame: Through study completion (an average of 3 years)

Secondary Outcomes

Physical activity

Physical activity will be measured using accelerometers (Actigraph model wGT3X-BT, LLC, Fort Walton Beach, FL).

Time frame: Baseline, 6 and 9 months

Systolic and diastolic blood pressure

Blood pressure will be measured using a Dinamap XL automated BP monitor according to current recommendations.

Time frame: Baseline, 6 and 9 months

Body weight

Body weight will be measured using an electronic scale.

Time frame: Baseline, 6 and 9 months

Height

Height will be measured using a tape measure.

Data from ClinicalTrials.gov

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