Clinical trial NCT05699642: Online Tai Chi Plus Fitbit After ACS
Official title: Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Physical Inactivity
Keywords: tai chi
fitness tracker
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Lifespan
First posted: 2023-01-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

1. History of ACS (unstable angina, NSTEMI, and STEMI, defined per current AHA/ACC criteria);
2. Age ≥ 18;
3. Being physically inactive (i.e., \< 150 min/week of moderate-intensity aerobic PA);
4. Absence of contraindications to physical exercise per the participant's provider evaluation;
5. Access to a digital device with internet connection;
6. Having an active email account and ability to check email at least weekly;
7. 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;
8. English speaking

Exclusion Criteria:

1. Inability or unwillingness to give informed consent;
2. Blood pressure \>200/110 or orthostatic systolic blood pressure decrease \>20 mmHg at the baseline visit;
3. Uncontrolled/untreated atrial or ventricular arrhythmias or 3rd degree AV block;
4. Within 3 months of a diagnosis of pericarditis or myocarditis;
5. Medical conditions likely to limit lifespan to less than one year;
6. New York Heart Association (NYHA) functional class IV;
7. Severe cognitive impairment (BOMC \>10);139
8. Orthopedic problems prohibiting TC practice;
9. Ongoing TC or other mind-body training (i.e., meditation, TC, or yoga) at least weekly;
10. Current enrollment in cardiac rehabilitation;
11. Untreated severe depression (PHQ\>=20);
12. Conditions likely to affect study compliance (i.e., moving out of study area, substance use, ongoing untreated psychosis);
13. Symptoms of unstable cardiovascular disease (e.g., shortness of breath or chest pain at rest and/or Canadian Cardiovascular Society Angina Class III-IV)

Primary outcomes:
measure: Recruitment rate
timeFrame: Through study completion (an average of 3 years)
measure: Retention rate
timeFrame: Through study completion (an average of 3 years)
measure: Intervention enjoyment
timeFrame: 6 months
measure: Intervention adherence
timeFrame: Through study completion (an average of 3 years)
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline, 6 and 9 months
measure: Systolic and diastolic blood pressure
timeFrame: Baseline, 6 and 9 months
measure: Body weight
timeFrame: Baseline, 6 and 9 months
measure: Height
timeFrame: Baseline
measure: Fasting glucose
timeFrame: Baseline, 6 and 9 months
measure: Lipid panel
timeFrame: Baseline, 6 and 9 months
measure: hs-CRP
timeFrame: Baseline, 6 and 9 months
measure: Quality of life assessed by SF-36
timeFrame: Baseline, 6 and 9 months
measure: Intrinsic motivation
timeFrame: Baseline, 6 and 9 months
measure: Anxiety, Depression
timeFrame: Baseline, 6 and 9 months
measure: Stress
timeFrame: Baseline, 6 and 9 months
measure: Mindful awareness
timeFrame: Baseline, 6 and 9 months
measure: Exercise self-efficacy
timeFrame: Baseline, 6 and 9 months
measure: Exercise capacity
timeFrame: Baseline, 6 and 9 months
Other outcomes:
measure: Socio-demographics
timeFrame: Baseline
measure: Medical history
timeFrame: Baseline
measure: Social support
timeFrame: Baseline
measure: Neighborhood barriers to physical activity
timeFrame: Baseline
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: