Online Tai Chi Plus Fitbit After ACS

NCT05699642 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2022P000891
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Physical Inactivity

Keywords

tai chi; fitness tracker

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

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

  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.

  Through study completion (an average of 3 years)

• Intervention enjoyment

  Intervention enjoyment will be assessed via qualitative interviews

  6 months

• Intervention adherence

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

  Through study completion (an average of 3 years)

Secondary Outcomes (14)

• Physical activity

  Baseline, 6 and 9 months

• Systolic and diastolic blood pressure

  Baseline, 6 and 9 months

• Body weight

  Baseline, 6 and 9 months

• Height

  Baseline

• Fasting glucose

  Baseline, 6 and 9 months

Other Outcomes (4)

• Socio-demographics

  Baseline

• Medical history

  Baseline

• Social support

  Baseline

Study Arms (2)

Tai chi + wearable

EXPERIMENTAL

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.

Behavioral: Tai chi + wearable

Enhanced usual care

NO INTERVENTION

Printed educational materials based on existing resources (e.g., AHA; Centers for Disease Control and Prevention) will be shared with subjects in this group.

Interventions

Tai chi + wearable BEHAVIORAL

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.

Tai chi + wearable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Lifespan: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Sedentary Behavior

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 26, 2023
• Study Start: August 27, 2024
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)