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Active Not RecruitingNCT05699642

Online Tai Chi Plus Fitbit After ACS

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Beth Israel Deaconess Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALTai chi + wearableThe 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.

Timeline

Start date
2024-08-27
Primary completion
2026-06-15
Completion
2026-06-15
First posted
2023-01-26
Last updated
2026-02-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05699642. Inclusion in this directory is not an endorsement.