Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05699642
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-01-06
Brief Title:
Online Tai Chi Plus Fitbit After ACS
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mind2Move
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 n70 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-monitoringfeedback 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None