Clinical trial NCT06401148: Exercise-based Cardiac Rehabilitation for Atrial Fibrillation
Official title: Exercise-based Cardiac Rehabilitation for Patients with Atrial Fibrillation Receiving Catheter Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Liverpool Heart and Chest Hospital NHS Foundation Trust
First posted: 2024-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \>180/100.
* Unstable angina.
* Severe valvular heart disease as diagnosed by echocardiography.
* Heart failure New York Heart Association (NYHA) class 4.
* \<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.

Primary outcomes:
measure: Number of patients screened, eligible and approached
timeFrame: Baseline
measure: Patient focus groups to assess intervention and testing acceptability
timeFrame: Up to 20 weeks from baseline
measure: Clinical exercise physiologist interview to assess intervention and testing acceptability
timeFrame: Up to 20 weeks from baseline
Secondary outcomes:
measure: Changes in AF burden
timeFrame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
measure: AF Recurrence
timeFrame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
measure: Disease specific quality of life measured by the AFEQT questionnaire
timeFrame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
measure: General quality of life as measured by the EQ-5D-5L questionnaire
timeFrame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
measure: VO2 peak measured via CPET
timeFrame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
measure: Exercise capacity measured via the 6MWT
timeFrame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
measure: Cardiac structure and function measured via echocardiography
timeFrame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
Study officials:
affiliation: Liverpool John Moores University
name: Benjamin Buckley, PhD
role: PRINCIPAL_INVESTIGATOR
References: