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NCT05699642 | Not yet recruiting | Acute Coronary Syndrome

Online Tai Chi Plus Fitbit After ACS
Sponsor:

Beth Israel Deaconess Medical Center

Information provided by (Responsible Party):

Gloria Y. Yeh

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.

Condition or disease

Acute Coronary Syndrome

Physical Inactivity

Intervention/treatment

Taichi + Uearabe

Phase

Phase 2

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 Type : Interventional
Estimated Enrollment : 70 participants
Masking : Single
Primary Purpose : Other
Official Title : Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors
Actual Study Start Date : April 15, 2024
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2025
Arm Intervention/treatment

Experimental: Taichi + Uearabe

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.

No Intervention: Enhanced usual care

Printed educational materials based on existing resources (e.g., AHA; Centers for Disease Control and Prevention) will be shared with subjects in this group.
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • History of ACS (unstable angina, NSTEMI, and STEMI, defined per current AHA/ACC criteria);
  • Age ≥ 18;
  • Being physically inactive (i.e., < 150 min/week of moderate-intensity aerobic PA);
  • Absence of contraindications to physical exercise per the participant's provider evaluation;
  • Access to a digital device with internet connection;
  • Having an active email account and ability to check email at least weekly;
  • 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;
  • English speaking
Exclusion Criteria
  • Inability or unwillingness to give informed consent;
  • Blood pressure >200/110 or orthostatic systolic blood pressure decrease >20 mmHg at the baseline visit;
  • Uncontrolled/untreated atrial or ventricular arrhythmias or 3rd degree AV block;
  • Within 3 months of a diagnosis of pericarditis or myocarditis;
  • Medical conditions likely to limit lifespan to less than one year;
  • New York Heart Association (NYHA) functional class IV;
  • Severe cognitive impairment (BOMC >10);139
  • Orthopedic problems prohibiting TC practice;
  • Ongoing TC or other mind-body training (i.e., meditation, TC, or yoga) at least weekly;
  • Current enrollment in cardiac rehabilitation;
  • Untreated severe depression (PHQ>=20);
  • Conditions likely to affect study compliance (i.e., moving out of study area, substance use, ongoing untreated psychosis);
  • Symptoms of unstable cardiovascular disease (e.g., shortness of breath or chest pain at rest and/or Canadian Cardiovascular Society Angina Class III-IV)
Online Tai Chi Plus Fitbit After ACS

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Online Tai Chi Plus Fitbit After ACS

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