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Atrial FibrillationExCR-AFNCT06401148

Exercise-based Cardiac Rehabilitation for Atrial Fibrillation

A study testing Cardiac rehab intervention group in people with Atrial Fibrillation, run by Liverpool John Moores University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Cardiac rehab intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
22 Aug 2024to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

Benjamin Buckley, PhD contact

‭0151 231 2121‬

B.J.Buckley@ljmu.ac.uk

Charlotte Fitzhugh, MSc contact

c.fitzhugh@2023.ljmu.ac.uk

United Kingdom1 site, 1 recruiting
  • Liverpool John Moores University

    Liverpool

    Benjamin Buckley, 0151 231 2121‬, B.J.Buckley@ljmu.ac.uk

    Charlotte Fitzhugh, c.fitzhugh@2023.ljmu.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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).

Read the 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.

Being tested
Cardiac rehab intervention group
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac rehab intervention groupBehavioural

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

Study groups in NCT06401148
Study groupRoleWhat they receive
Exercise-based cardiac rehabilitationExperimentalParticipants will complete an 8-week-long cardiac rehabilitation programme consisting of supervised exercise sessions run by a clinical exercise physiologist and psychoeducation sessions.
Receives: Behavioral: Cardiac rehab intervention group
Treatment as UsualNo interventionParticipants randomised to usual care will not receive any intervention but continue with usual medical treatment for their AF as determined by their healthcare team.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. Patient focus groups to assess intervention and testing acceptability

    Patient Focus Groups

    Measured: Up to 20 weeks from baseline

  3. Clinical exercise physiologist interview to assess intervention and testing acceptability

    Clinical Exercise Physiologist Interview

    Measured: Up to 20 weeks from baseline

Secondary outcomes (7)
  1. 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).

    Measured: At baseline, post intervention (8-10 weeks) and 6 months after intervention

  2. 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.

    Measured: At baseline, post intervention (8-10 weeks) and 6 months after intervention

  3. 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).

    Measured: At baseline, post intervention (8-10 weeks) and 6 months after intervention

  4. 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.

    Measured: At baseline, post intervention (8-10 weeks) and 6 months after intervention

  5. 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.

    Measured: At baseline, post intervention (8-10 weeks) and 6 months after intervention

  6. 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).

    Measured: At baseline, post intervention (8-10 weeks) and 6 months after intervention

  7. 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.

    Measured: At baseline, post intervention (8-10 weeks) and 6 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start22 Aug 2024
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401148
Sponsor's protocol ID
Interventional
Acronym
ExCR-AF
Status last verified
May 2024
First submitted
19 Apr 2024
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39890138

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac rehab intervention group in people with Atrial Fibrillation, run by Liverpool John Moores University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Benjamin Buckley, PhD (‭0151 231 2121‬, B.J.Buckley@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients screened, eligible and approached (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06401148, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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