Exercise-based Cardiac Rehabilitation for Atrial Fibrillation (ExCR-AF)

Liverpool John Moores University

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Behavioral: Cardiac rehab intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT06401148

Interventional (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exercise-based cardiac rehabilitation

Experimental group

Description:

Participants will complete an 8-week-long cardiac rehabilitation programme consisting of supervised exercise sessions run by a clinical exercise physiologist and psychoeducation sessions.

Treatment:

Behavioral: Cardiac rehab intervention group

Treatment as Usual

No Intervention group

Description:

Participants randomised to usual care will not receive any intervention but continue with usual medical treatment for their AF as determined by their healthcare team.