Online Tai Chi Plus Fitbit After ACS

Study Overview
=================
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.

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).

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

Conditions
-----------------
Acute Coronary Syndrome, Physical Inactivity

Intervention / Treatment
-----------------
* Behavioral: Tai chi + wearable


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai chi + wearable<br>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<br>* 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.<br>|
| No Intervention: Enhanced usual care<br>Printed 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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Physical activity will be measured using accelerometers (Actigraph model wGT3X-BT, LLC, Fort Walton Beach, FL). | 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. | Baseline, 6 and 9 months | 
| Body weight | Body weight will be measured using an electronic scale. | Baseline, 6 and 9 months | 
| Height | Height will be measured using a tape measure. | Baseline | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 
| 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. | Baseline, 6 and 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tai chi, fitness tracker