Exercise-based Cardiac Rehabilitation for Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-22

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise-based cardiac rehabilitation

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

Group Type EXPERIMENTAL

Cardiac rehab intervention group

Intervention Type BEHAVIORAL

Participants will complete an 8-week cardiac rehabilitation programme supported by the onsite CR service.

Treatment as Usual

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cardiac rehab intervention group

Participants will complete an 8-week cardiac rehabilitation programme supported by the onsite CR service.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No