Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-03 @ 5:12 PM
Study NCT ID:
NCT06784895
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Designing and Assessing a Women Only Cardiac Rehabilitation Program
Status:
RECRUITING
Status Verified Date:
2025-11
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:
CARE
Brief Summary:
The purpose of this randomized controlled study is to investigate the effect(s) of a pilot women-only cardiac rehabilitation (CR) program. The study team will be testing the effectiveness, compliance and enjoyment of this women's only cardiac rehabilitation (CR) program by comparing outcomes to those randomized to receive Michigan Medicine's current CR program (standard care), which includes people of all genders.
Study hypotheses:
* Women randomized to women-specific CR programming will have superior attendance and completion rates compared to women attending mixed-sex CR programming.
* Women randomized to women-specific CR programming will experience greater improvement in clinical outcomes in comparison to those in mixed-sex CR programming.
Study hypotheses:
* Women randomized to women-specific CR programming will have superior attendance and completion rates compared to women attending mixed-sex CR programming.
* Women randomized to women-specific CR programming will experience greater improvement in clinical outcomes in comparison to those in mixed-sex CR programming.
Detailed Description:
This registration was updated on 11/24/2025 due to amendments that were approved at the IRBMED.
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?: