Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401148
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-19
Brief Title:
Exercise-based Cardiac Rehabilitation for Atrial Fibrillation
Sponsor:
Liverpool John Moores University
Organization:
Liverpool John Moores University
Study Overview
Official Title:
Exercise-based Cardiac Rehabilitation for Patients With Atrial Fibrillation Receiving Catheter Ablation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ExCR-AF
Brief Summary:
The investigators aim to conduct a pilot randomised controlled trial RCT with embedded feasibility study to evaluate an exercise-based cardiac rehabilitation ExCR programme when delivered to patients with atrial fibrillation on the waiting list for catheter ablation Our overall objective is to test the feasibility and acceptability of an evidence-based ExCR intervention prior to evaluation in a future randomized controlled trial RCT
Detailed Description:
A two-arm pilot randomised clinical trial RCT with embedded feasibility and process evaluation will be undertaken as a phased programme of work Patients on a waiting list for catheter ablation will be offered a referral to cardiac rehabilitation The intervention consists of supervised exercise sessions run by a clinical exercise physiologist and psychoeducation sessions Phase 1 n20 and phase 2 n60 will involve two National Health Service NHS research sites Liverpool Heart and Chest NHS Foundation Trust and Wirral Community Health and Care NHS Foundation Trust enrolling patients to assess intervention and study design processes Primary outcomes are recruitment rate adherence to the ExCR and loss to follow-up Semi-structured interviews and focus groups with patients and clinicians will be used to gather data on the acceptability of the intervention and study procedures Secondary outcome measures will be taken at baseline preintervention postintervention and at 6 month follow-up for both phases and will consist of exercise capacity measured by AF burden AF recurrence quality of life exercise capacity and cardiac structure and function
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