Exercise-based Cardiac Rehabilitation for Patients with Atrial Fibrillation Receiving Catheter Ablation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Liverpool John Moores University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Patient focus groups to assess intervention and testing acceptability
- Status
- Recruiting
- Last Updated
- last year
Overview
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 feasibility trial (RCT) with embedded 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. The trial will involve one National Health Service (NHS) research site, Liverpool Heart and Chest NHS Foundation Trust enrolling patients (n=60) 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is willing and able to give informed consent for participation in the study.
- •Aged ≥18 years.
- •Diagnosed with AF and on a waiting list or referred for medical treatment for symptomatic AF (eg catheter ablation).
- •Is eligible and willing to take part in an ExCR programme.
Exclusion Criteria
- •Blood pressure \>180/
- •Unstable angina.
- •Severe valvular heart disease as diagnosed by echocardiography.
- •Heart failure New York Heart Association (NYHA) class
- •\<6 months post-transplant.
- •Resting/uncontrolled tachycardia.
- •Stroke in last 6 weeks.
- •Cardiac sarcoidosis.
- •Injury or disability preventing exercise.
- •Inability to understand trial procedures e.g. difficulties with speaking and understanding the English language.
Outcomes
Primary Outcomes
Patient focus groups to assess intervention and testing acceptability
Time Frame: Up to 20 weeks from baseline
Patient Focus Groups
Clinical exercise physiologist interview to assess intervention and testing acceptability
Time Frame: Up to 20 weeks from baseline
Clinical Exercise Physiologist Interview
Number of patients screened, eligible and approached
Time Frame: Baseline
The percentage of patients that are screened, eligible and approached decline CR (including reasons for declining) agree to CR and consent to being part of the study The percentage of patients that take up standard CR and reasons for drop out; and the percentage of participants that complete outcome assessments and reasons for drop out.
Secondary Outcomes
- Changes in AF burden(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- AF Recurrence(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- Disease specific quality of life measured by the AFEQT questionnaire(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- General quality of life as measured by the EQ-5D-5L questionnaire(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- VO2 peak measured via CPET(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- Exercise capacity measured via the 6MWT(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- Cardiac structure and function measured via echocardiography(At baseline, post intervention (8-10 weeks) and 6 months after intervention)