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Acute Coronary SyndromePhase 2Mind2MoveNCT05699642

Online Tai Chi Plus Fitbit After ACS

A Phase 2 study testing Tai chi + wearable in people with Acute Coronary Syndrome and Physical Inactivity, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome, Physical Inactivity
What is being tested?
Tai chi + wearable
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
27 Aug 2024to 1 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 13Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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

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

Read the 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).

Being tested
Tai chi + wearable
Keywords
tai chi, fitness tracker
Medical subject headings
Acute Coronary Syndrome, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai chi + wearableBehavioural

    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.

Study groups in NCT05699642
Study groupRoleWhat they receive
Tai chi + wearableExperimental48 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.
Receives: Behavioral: Tai chi + wearable
Enhanced usual careNo interventionPrinted educational materials based on existing resources (e.g., AHA; Centers for Disease Control and Prevention) will be shared with subjects in this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

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

    Measured: Through study completion (an average of 3 years)

  2. Retention rate

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

    Measured: Through study completion (an average of 3 years)

  3. Intervention enjoyment

    Intervention enjoyment will be assessed via qualitative interviews

    Measured: 6 months

  4. Intervention adherence

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

    Measured: Through study completion (an average of 3 years)

Secondary outcomes (14)

  1. Physical activity

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

    Measured: Baseline, 6 and 9 months

  2. Systolic and diastolic blood pressure

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

    Measured: Baseline, 6 and 9 months

  3. Body weight

    Body weight will be measured using an electronic scale.

    Measured: Baseline, 6 and 9 months

  4. Height

    Height will be measured using a tape measure.

    Measured: Baseline

  5. Fasting glucose

    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.

    Measured: Baseline, 6 and 9 months

  6. Lipid panel

    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.

    Measured: Baseline, 6 and 9 months

  7. hs-CRP

    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.

    Measured: Baseline, 6 and 9 months

  8. Quality of life assessed by SF-36

    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.

    Measured: Baseline, 6 and 9 months

  9. Intrinsic motivation

    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.

    Measured: Baseline, 6 and 9 months

  10. Anxiety, Depression

    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.

    Measured: Baseline, 6 and 9 months

  11. Stress

    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.

    Measured: Baseline, 6 and 9 months

  12. Mindful awareness

    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.

    Measured: Baseline, 6 and 9 months

  13. Exercise self-efficacy

    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.

    Measured: Baseline, 6 and 9 months

  14. Exercise capacity

    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.

    Measured: Baseline, 6 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start27 Aug 2024
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05699642
Sponsor's protocol ID
2022P000891
Acronym
Mind2Move
Status last verified
Aug 2026
First submitted
6 Jan 2023
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tai chi + wearable in people with Acute Coronary Syndrome and Physical Inactivity, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Through study completion (an average of 3 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05699642.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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