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

Exercise-based Cardiac Rehabilitation for Patients with Atrial Fibrillation Receiving Catheter Ablation

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).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Behavioral: Cardiac rehab intervention group

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin Buckley, PhD; Phone Number: ‭0151 231 2121‬; Email: B.J.Buckley@ljmu.ac.uk
• Study Contact Backup: Name: Charlotte Fitzhugh, MSc; Email: c.fitzhugh@2023.ljmu.ac.uk

Study Locations

• United Kingdom
  • Liverpool, United Kingdom
    • Recruiting
    • Liverpool John Moores University
    • Contact: Benjamin Buckley; Phone Number: 0151 231 2121; Email: B.J.Buckley@ljmu.ac.uk
    • Contact: Charlotte Fitzhugh; Email: c.fitzhugh@2023.ljmu.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: Cardiac rehab intervention group; Participants will complete an 8-week cardiac rehabilitation programme supported by the onsite CR service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in AF burden	Changes in atrial fibrillation burden as measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS). The AFSS is a disease-specific measure used to capture subjective and objective ratings of disease burden in patients with atrial fibrillation. It assesses atrial fibrillation burden (score 1-30; higher scores indicate higher burden); Global Well Being (a visual analogue scale ranging from 1-10, indicating a patient reports as having a worst possible life [0] to the best possible life[10]); AF symptom score (score of 0-35; higher scores indicate more bothered by AF symptoms); and health care utilization (score of 0-21; higher scores indicate greater health care utilization).	At baseline, post intervention (8-10 weeks) and 6 months after intervention
AF Recurrence	AF recurrence will be measured using the AliveCor KardiaMobile which is a hand-held one lead electrocardiogram (ECG) device. Kardia Mobile is an FDA approved device that allows six lead ECG recording for 30 seconds using the patient's smart phone. The device has a automated algorithm that interprets the ECG as either 'sinus rhythm', 'AF', or 'unclassified'. We will be collecting the counts of these classifications to assess the number of AF episodes.	At baseline, post intervention (8-10 weeks) and 6 months after intervention
Disease specific quality of life measured by the AFEQT questionnaire	Health related quality of life as measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). The AFEQT assesses 4 domains: symptoms, activities, treatment concern, treatment satisfaction, and a summary score that includes the first 3 domains. Patients will assess the impact of AF on their health status during the previous 4 weeks. Responses are presented on a 7-point Likert scale. Raw scores within each domain are transformed from a 0 (most severe symptoms) to a 100 scale (no limitations or disability).	At baseline, post intervention (8-10 weeks) and 6 months after intervention
General quality of life as measured by the EQ-5D-5L questionnaire	The 5-level EuroQol-5 Dimensions (EQ-5D-5L) is a parsimonious measure of health-related quality of life consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. It also includes a Visual Analogue Scale (EQ-VAS) aimed at capturing participants' rating of their 'health today' on a scale from 0-100 with 100 being the best state and 0 being the worst state. The EQ-5D will also be used to inform economic evaluation.	At baseline, post intervention (8-10 weeks) and 6 months after intervention
VO2 peak measured via CPET	Maximal oxygen consumption (VO2peak) will be measured using cardiopulmonary exercise testing (CPET). Peak exhaustion will be evaluated by several variables (e.g. respiratory exchange ratio ≥T 1.10, heart rate and subjective exhaustion of the patient). VO2peak will be defined as the peak VO2 reached during the test. The test will be performed by two members of the research team. For safety reasons, pre-set criteria for initiation and/or termination of the test have been defined. Additional variables will include ventilatory thresholds (VT1 and VT2), VO2 slopes, and O2 pulse.	At baseline, post intervention (8-10 weeks) and 6 months after intervention
Exercise capacity measured via the 6MWT	The maximum walking distance (in metres) within 6 minutes will be used to assess exercise capacity, measured via the six-minute walk test (6MWT).	At baseline, post intervention (8-10 weeks) and 6 months after intervention
Cardiac structure and function measured via echocardiography	Transthoracic Echocardiography (echo) will be performed by a clinically accredited echocardiographic. Cardiac structure and function will be assessed non-invasively with the participant lying on their left side. Standard 2-dimensional (2D), 3-dimensional (3D) Doppler, tissue-Doppler (TDI) and M Mode scans will be performed using a commercially available ultrasound system (Vivid iQ, GE Medical, Horton, Norway) with a 1.5-4 megahertz (MHz) phased array transducer applied to the participant's chest. A full level 2 transthoracic assessment in keeping with the British Society of Echocardiography) BSE minimum dataset, including left ventricular ejection fraction, left atrial volume, left atrial strain (and rate), left atrial volumetric function, left ventricle filling pressures, right atrial strain and exploratory 3D volumes.	At baseline, post intervention (8-10 weeks) and 6 months after intervention

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Collaborators: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Benjamin Buckley, PhD, Liverpool John Moores University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No