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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Charlotte Fitzhugh, MSc contact
United Kingdom1 site, 1 recruiting
- 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
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.
- Conditions
- Atrial Fibrillation
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Patient focus groups to assess intervention and testing acceptability
Patient Focus Groups
Measured: Up to 20 weeks from baseline
Clinical exercise physiologist interview to assess intervention and testing acceptability
Clinical Exercise Physiologist Interview
Measured: Up to 20 weeks from baseline
Secondary outcomes (7)
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
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
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
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
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
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
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.
- First posted6 May 2024
- Study start22 Aug 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Benjamin Buckley, PhD, Principal investigator, Liverpool John Moores University
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-based Cardiac Rehabilitation for Patients with Atrial Fibrillation Receiving Catheter Ablation
- ClinicalTrials.gov ID
- NCT06401148
- Acronym / sponsor ID
- ExCR-AF / Interventional
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise-based cardiac rehabilitation | Experimental | Behavioral: Cardiac rehab intervention groupParticipants will complete an 8-week-long cardiac rehabilitation programme consisting of supervised exercise sessions run by a clinical exercise physiologist and psychoeducation sessions. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehab intervention groupParticipants will complete an 8-week cardiac rehabilitation programme supported by the onsite CR service. | Behavioural | Exercise-based cardiac rehabilitation |
Primary outcome
Number of patients screened, eligible and approached
Time frame: Baseline
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.
Patient focus groups to assess intervention and testing acceptability
Time frame: Up to 20 weeks from baseline
Patient Focus Groups
Clinical exercise physiologist interview to assess intervention and testing acceptability
Time frame: Up to 20 weeks from baseline
Clinical Exercise Physiologist Interview
7 secondary outcomes
Changes in AF burden
Time frame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
AF Recurrence
Time frame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
Disease specific quality of life measured by the AFEQT questionnaire
Time frame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
General quality of life as measured by the EQ-5D-5L questionnaire
Time frame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
VO2 peak measured via CPET
Time frame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
Exercise capacity measured via the 6MWT
Time frame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
Cardiac structure and function measured via echocardiography
Time frame: At baseline, post intervention (8-10 weeks) and 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Derived from this study: PubMed 39890138Fitzhugh 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.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Fitzhugh, MSc contact
Benjamin Buckley, PhD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
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.