Exercise-based Cardiac Rehabilitation for Atrial Fibrillation

NCT06401148 | Recruiting

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Number of patients screened, eligible and approached

  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.

  Baseline

• Patient focus groups to assess intervention and testing acceptability

  Patient Focus Groups

  Up to 20 weeks from baseline

• Clinical exercise physiologist interview to assess intervention and testing acceptability

  Clinical Exercise Physiologist Interview

  Up to 20 weeks from baseline

Secondary Outcomes (7)

• 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

Study Arms (2)

Exercise-based cardiac rehabilitation

EXPERIMENTAL

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

Behavioral: Cardiac rehab intervention group

Treatment as Usual

NO INTERVENTION

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.

Interventions

Cardiac rehab intervention group BEHAVIORAL

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

Exercise-based cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Liverpool Heart and Chest Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Liverpool John Moores University

Liverpool, United Kingdom

RECRUITING

Related Publications (1)

• Fitzhugh C, Jones H, Foweather L, Lip GYH, Gupta D, Mills MT, Buckley BJ. Exercise-based cardiac rehabilitation for patients with atrial fibrillation receiving catheter ablation: protocol for a feasibility randomised controlled trial (RCT) with embedded process evaluation. BMJ Open. 2025 Jan 30;15(1):e088460. doi: 10.1136/bmjopen-2024-088460.

  PMID: 39890138 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin Buckley, PhD

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Buckley, PhD

CONTACT

‭0151 231 2121‬; B.J.Buckley@ljmu.ac.uk

Charlotte Fitzhugh, MSc

CONTACT

c.fitzhugh@2023.ljmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 6, 2024
• Study Start: August 22, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)