Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05699642

Online Tai Chi Plus Fitbit After ACS

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Coronary Syndrome Behavior Cardiovascular Diseases Heart Diseases Myocardial Ischemia Physical Inactivity Sedentary Behavior Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 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.

  2. Retention rate

    Time frame: 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.

  3. Intervention enjoyment

    Time frame: 6 months

    Intervention enjoyment will be assessed via qualitative interviews

  4. Intervention adherence

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

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

Secondary outcomes

  1. Physical activity

    Time frame: Baseline, 6 and 9 months

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

  2. Systolic and diastolic blood pressure

    Time frame: Baseline, 6 and 9 months

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

  3. Body weight

    Time frame: Baseline, 6 and 9 months

    Body weight will be measured using an electronic scale.

  4. Height

    Time frame: Baseline

    Height will be measured using a tape measure.

  5. Fasting glucose

    Time frame: 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.

  6. Lipid panel

    Time frame: 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.

  7. hs-CRP

    Time frame: 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.

  8. Quality of life assessed by SF-36

    Time frame: 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.

  9. Intrinsic motivation

    Time frame: 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.

  10. Anxiety, Depression

    Time frame: 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.

  11. Stress

    Time frame: 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.

  12. Mindful awareness

    Time frame: 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.

  13. Exercise self-efficacy

    Time frame: 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.

  14. Exercise capacity

    Time frame: 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.

Other outcomes

  1. Socio-demographics

    Time frame: Baseline

    Age, sex, race/ethnicity, education, income, insurance status will be collected from the EMR using standard abstraction forms.

  2. Medical history

    Time frame: Baseline

    Coronary risk factors; coronary revascularization procedures; ejection fraction; New York Heart Association class; CHD severity (one-, two- or three-vessel from coronary angiogram); co-morbidities; CR information (history of participation, reasons for decline); comorbidities (Charlson index); medications] will be abstracted from medical records using standard abstraction forms that have been validated in previous studies.

  3. Social support

    Time frame: Baseline

    Social support will be measured with the Multidimensional Scale of Perceived Social Support is a 12-item, unidimensional tool to measure how one perceives their social support system, including the individual's sources of social support (i.e., family, friends, and significant others). Scores range from 12-84, with a higher score meaning more perceived social support.

  4. Neighborhood barriers to physical activity

    Time frame: Baseline

    PANES (Physical Activity Neighborhood Environment Survey) also known as the International Physical Activity Prevalence Study Self-Administered Environmental Module is a 17-item Scale that can be used to assess the environmental factors for walking and bicycling in various neighborhoods. Scores range from 17-68, with higher scores indicating a neighborhood environment that is more conducive to physical activity.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Lifespan

Registry information

Official study title

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

Acronym: Mind2Move

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.