Atrial Fibrillation (Paroxysmal)BI-PAFNCT07454317
Biofeedback Intervention for Paroxysmal Atrial Fibrillation
A study testing Biofeedback intervention in people with Atrial Fibrillation (Paroxysmal), run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
This project aims to bridge the gap between technology and healthcare by developing a biofeedback intervention that enables daily monitoring of atrial fibrillation episodes and physical activity levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal)
- What is being tested?
- Biofeedback intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 or over.
- Diagnosed with paroxysmal AF
- Deemed medically stable and well managed.
Who cannot join
- Any concurrent cardiac arrhythmia
- Blood pressure >180/100
- Unstable angina
- Myocardial infarction within the previous 3 months
- Valvular heart disease
- Heart failure NYHA class 4
Show all 11Show fewer
- <6 months post-transplant
- Resting/uncontrolled tachycardia
- Stroke in last 6 weeks
- Cardiac sarcoidosis
- Injury or disability preventing exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
Luca J Howard, +44 151 231 2121, l.j.howard@ljmu.ac.uk
About this study
Official title: Remote Physical Activity Biofeedback Intervention for Patients With Paroxysmal Atrial Fibrillation Using Mobile Health Technology.
This project aims to bridge the gap between technology and healthcare by developing a biofeedback intervention that enables daily monitoring of atrial fibrillation episodes and physical activity levels. The main question it aims to answer is:
Is a co-designed, usability-tested, bio-feedback intervention aimed at nudging patients with paroxysmal atrial fibrillation to increase physical activity feasible for a larger randomised control trial?
Read more
The trial is split into two separate phases, each adopting different study designs, data collection, and data analysis methods.
Phase 1 Co-design and usability testing:
In this phase, we aim to test if smartwatches can be used to monitor AF and physical activity so that personalised atrial fibrillation-specific summaries can be created and sent to participants as text message nudges. The aim is to encourage participants to be more physically active.
Participants will wear a smartwatch for 3 weeks, during which they will receive text messages giving them feedback on their atrial fibrillation and physical activity. After the 3 weeks, all participants will take part in a workshop to provide feedback on what they thought and what could be improved. Improvements will be implemented by the researchers, and the process will repeat for a total of two iterations. On the first iteration only, participants will also be asked to wear a Holter monitor OR chest strap and an additional smartwatch for the first 24 hours, alongside an accelerometer watch for the first 7 days.
Phase 2 Feasibility study with embedded process evaluation:
This phase aims to assess whether it is feasible and acceptable to run a larger trial across the UK (i.e. can the intervention be delivered properly and do patients think it is useful).
Participants will be randomly allocated to either their normal standard of care, or to receive a smartwatch with the biofeedback messaging service in addition to their normal standard of care. The study will take 6 and a half months in total. Both groups will complete online questionnaires periodically over this period. Both groups will also need to wear a smartwatch and accelerometer watch for 7 days before and after testing.
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Being tested
- Biofeedback intervention
- Keywords
- Atrial fibrillation, Physical activity, Behavioural economics, Nudge theory, Wrist worn technology, mHealth
- Medical subject headings
- Atrial Fibrillation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback interventionBehavioural
Participants wearing a smartwatch will receive feedback on their paroxysmal atrial fibrillation and physical activity. This feedback will hopefully nudge them to become more physically active.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Biofeedback intervention + standard care | Experimental | If allocated to the intervention group, you will be sent a smartwatch and device introduction pack with information on how to download a custom mobile application named Motivate-cloud and the Polar Flow mobile application, with instructions on how to sync your Polar device. Once set up, you will wear the smartwatch device for 6-months that records heart rate and physical activity. During this time, you will be sent regular text messages with motivating information on your activity (steps, time sitting, standing and moving) and AF. *Important note: when we send you messages regarding your risk of AF, this is based on your heart rate variability (i.e. the variation in time between heart beats), and based on this variation, we predict we can determine whether the risk of being in AF has gone up or down for a given period of time.* Receives: Behavioral: Biofeedback intervention |
| Group 2: Standard care | No intervention | You would have had a conversation about the benefits of lifestyle and physical activity with your direct health care team prior to agreeing to receiving contact with the research team. If you are allocated to this group, you will continue with usual medical treatment for your atrial fribrillation as determined by your healthcare team. You will receive adequate information and support, lifestyle advice about smoking, exercise, diet, and weight control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Co-design biofeedback nudges and report content, layout and the optimal time/frequency of nudges. Underpinned by a double diamond framework, through an iterative co-design process.
- Patients' qualitative data (workshops and/or 1:1 feedback meetings) investigating nudges and report: A) Content B) Layout C) Delivery Intervals
Measured: Immediately after the 3-week usability testing iterations.
Phase 1: Co-design biofeedback nudges and report content, layout and the optimal time/frequency of nudges. Underpinned by a double diamond framework, through an iterative co-design process.
- Participants' reflection/feedback via user diaries.
Measured: During each 3-week usability testing period.
Phase 2: Determine the number of patients identified, screened, appraoched eligable, consented, completed the trial, withdrew from the trial, and adherence to the trial.
Outcome measure:
Information will be collected on:
- The number of patients screened, eligible and approached.
- The percentage of patients that:
- Decline the biofeedback intervention (including reasons for declining). B) Agree to the biofeedback intervention. C) Consent to being part of the study.
- The percentage of patients that take up the biofeedback intervention and reasons for drop out.
- The percentage of participants that complete outcome assessments and reasons for drop out.
- The percentage time individuals wear the devices.
Measured: Through study recruitment and all data collection, an average of 2 years.
Secondary outcomes (22)
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
- Multidisciplinary stakeholder groups including the research team and patients' qualitative data (workshops and/or 1:1 feedback meetings) investigating: A) General usability and acceptability. B) Faults or problem identification. C) Intervention delivery optimisation.
Measured: Immediately after the 3-week usability testing iterations
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
- Participants reflection / feedback via user diaries.
Measured: During each 3-week usability testing period.
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
- Researcher observations
Measured: Through study recruitment and data collection, an average of 4 months
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
- Systems usability scale (SUS) questionnaire during the first co-design workshop. Scored from 0-100. Higher score = better usability (outcome).
Measured: Immediately after the first 3-week usability testing iteration.
Phase 1: Quantify the time taken and resources required to produce nudges to gain an understanding of the maximum potential active intervention participants that can be simultaneously ongoing in Phase-2 feasibility RCT
Information will be collected on:
- The average time taken to produce each nudge (measured from accessing patient account to sending item).
- Any identified issues with the intervention (via researcher diary).
Measured: Through study recruitment and data collection, an average of 4 months
Phase 1: Investigate the validity and quantify the error of the Polar Pacer smartwatch HRV data against a clinical-grade Holter monitor, or the Polar H10 chest strap.
- Continuous HRV data from both devices simultaneously to evaluate: A) Validity and reliability of the Polar Pacer HRV data. B) Error associated with Polar Pacer HRV data. C) Measurement error at each MET threshold. D) Optimal MET threshold cut off for HRV (risk of AF) analysis. E) Considerations for any future validation studies.
Measured: First 24-hour periprocedural period.
Phase 1: Investigate the reliability and quantify the error of the Polar Pacer activity score as a measurement of PA against the GENEactiv wrist-based accelerometer
- Simultaneous collection of accelerometer and PA data from both devices to evaluate: A) Reliability of the Polar Pacer activity score as a measure of PA. B) PA measurement error of the Polar Pacer. C) Considerations for any future validation studies.
Measured: First 7-days of periprocedural period.
Phase 2: 2) Evaluate the acceptability of the intervention to patients, assessing the feasibility of delivering the biofeedback intervention to patients with paroxysmal AF
Qualitative acceptability assessment through topic-guided semi-structured 1:1 interviews post-intervention, investigating:
- The acceptability of the intervention components and barriers and facilitators to the intervention.
- Acceptability of the study design and process (recruitment, randomisation, remote design)
- Acceptability of the measurement instruments.
Measured: Within 1 month of completing all 6-month post-intervention data collection.
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.1) Physical activity (steps) measured via Polar Pacer smartwatch and GENEactiv wrist-based accelerometer.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer steps additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.2) Physical activity (time spent sleeping) measured via Polar Pacer smartwatch and GENEactiv wrist-based accelerometer.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent sleeping additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.3) Physical activity (time spent sitting) measured via Polar Pacer smartwatch and GENEactiv wrist-based accelerometer.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent sitting additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.4) Physical activity (time spent standing) measured via Polar Pacer smartwatch and GENEactiv wrist-based accelerometer.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent standing additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.5) Physical activity (time spent in light activity) measured via Polar Pacer smartwatch and GENEactiv wrist-based accelerometer.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent in light activity additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.6) Physical activity (time spent in moderate activity) measured via Polar Pacer smartwatch and GENEactiv wrist-based accelerometer.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent in moderate activity additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.7) Physical activity (time spent in vigorous activity) measured via Polar Pacer smartwatch and GENEactiv wrist-based accelerometer.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent in vigorous activity additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.8) Physical activity (calories) measured via Polar Pacer smartwatch
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer calories additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
1.9) Physical activity (total METs) measured via Polar Pacer smartwatch.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer total METs additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
- Health-related quality of life via the AF Effect on quality of life (AFEQT) scale. Scored from 0-100. Higher score = best possible quality of life.
Measured: 4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention)
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
- EuroQol, 5 Dimensions, 5 Levels of severity (EQ-5D-5L) questionnaire. Responses are combined into a 5-digit code, ranging from 11111 (perfect health) to 55555 (worst health). This 5-digit code is converted into a weighted index score that represents the societal value of that health state. A score of 1.000 represents full health.
Measured: 4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention)
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
- 12-Item Short Form Survey (SF-12). Measures physical and mental components of health, with each question carrying a different weighting. Norm-based scoring is used, allowing comparison to the general US population. A score of 50 is considered average health, with higher values indicating better health.
Measured: 4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention)
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
- AF symptom severity via the University of Toronto Atrial Fibrillation Symptom Severity (AFSS) questionnaire. Scores range from 0-35. Higher score indicate more severe symptoms.
Measured: 4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention)
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
- HRV (risk of AF) measured as % time with a risk of AF and number of episodes.
Measured: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer HRV additionally measured throughout 6-month intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Apr 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Paroxysmal)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454317
- Sponsor's protocol ID
- 25LJMUSPONSOR007
- Other IDs
- 360293
- Acronym
- BI-PAF
- Status last verified
- May 2026
- First submitted
- 28 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Physical Activity Biofeedback Intervention for Patients With Paroxysmal Atrial Fibrillation Using Mobile Health Technology.
- ClinicalTrials.gov ID
- NCT07454317
- Acronym / sponsor ID
- BI-PAF / 25LJMUSPONSOR007
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Keywords
- Atrial fibrillation, Physical activity, Behavioural economics, Nudge theory, Wrist worn technology, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 6 Mar 2026 (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.
This project aims to bridge the gap between technology and healthcare by developing a biofeedback intervention that enables daily monitoring of atrial fibrillation episodes and physical activity levels. The main question it aims to answer is:
Is a co-designed, usability-tested, bio-feedback intervention aimed at nudging patients with paroxysmal atrial fibrillation to increase physical activity feasible for a larger randomised control trial?
The trial is split into two separate phases, each adopting different study designs, data collection, and data analysis methods.
Phase 1 Co-design and usability testing:
In this phase, we aim to test if smartwatches can be used to monitor AF and physical activity so that personalised atrial fibrillation-specific summaries can be created and sent to participants as text message nudges. The aim is to encourage participants to be more physically active.
Participants will wear a smartwatch for 3 weeks, during which they will receive text messages giving them feedback on their atrial fibrillation and physical activity. After the 3 weeks, all participants will take part in a workshop to provide feedback on what they thought and what could be improved. Improvements will be implemented by the researchers, and the process will repeat for a total of two iterations. On the first iteration only, participants will also be asked to wear a Holter monitor OR chest strap and an additional smartwatch for the first 24 hours, alongside an accelerometer watch for the first 7 days.
Phase 2 Feasibility study with embedded process evaluation:
This phase aims to assess whether it is feasible and acceptable to run a larger trial across the UK (i.e. can the intervention be delivered properly and do patients think it is useful).
Participants will be randomly allocated to either their normal standard of care, or to receive a smartwatch with the biofeedback messaging service in addition to their normal standard of care. The study will take 6 and a half months in total. Both groups will complete online questionnaires periodically over this period. Both groups will also need to wear a smartwatch and accelerometer watch for 7 days before and after testing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- Biofeedback intervention + standard care | Experimental | Behavioral: Biofeedback interventionIf allocated to the intervention group, you will be sent a smartwatch and device introduction pack with information on how to download a custom mobile application named Motivate-cloud and the Polar Flow mobile application, with instructions on how to sync your Polar device. Once set up, you will wear the smartwatch device for 6-months that records heart rate and physical activity. During this time, you will be sent regular text messages with motivating information on your activity (steps, time sitting, standing and moving) and AF. *Important note: when we send you messages regarding your risk of AF, this is based on your heart rate variability (i.e. the variation in time between heart beats), and based on this variation, we predict we can determine whether the risk of being in AF has gone up or down for a given period of time.* |
| Group 2: Standard care | No intervention | –You would have had a conversation about the benefits of lifestyle and physical activity with your direct health care team prior to agreeing to receiving contact with the research team. If you are allocated to this group, you will continue with usual medical treatment for your atrial fribrillation as determined by your healthcare team. You will receive adequate information and support, lifestyle advice about smoking, exercise, diet, and weight control. |
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 or over.
- Diagnosed with paroxysmal AF
- Deemed medically stable and well managed.
Key exclusion criteria (11 listed)
- Any concurrent cardiac arrhythmia
- Blood pressure >180/100
- Unstable angina
- Myocardial infarction within the previous 3 months
- Valvular heart disease
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 |
|---|---|---|
| Biofeedback interventionParticipants wearing a smartwatch will receive feedback on their paroxysmal atrial fibrillation and physical activity. This feedback will hopefully nudge them to become more physically active. | Behavioural | Group 1- Biofeedback intervention + standard care |
Primary outcome
Phase 1: Co-design biofeedback nudges and report content, layout and the optimal time/frequency of nudges. Underpinned by a double diamond framework, through an iterative co-design process.
Time frame: Immediately after the 3-week usability testing iterations.
1) Patients' qualitative data (workshops and/or 1:1 feedback meetings) investigating nudges and report: A) Content B) Layout C) Delivery Intervals
Phase 1: Co-design biofeedback nudges and report content, layout and the optimal time/frequency of nudges. Underpinned by a double diamond framework, through an iterative co-design process.
Time frame: During each 3-week usability testing period.
2) Participants' reflection/feedback via user diaries.
Phase 2: Determine the number of patients identified, screened, appraoched eligable, consented, completed the trial, withdrew from the trial, and adherence to the trial.
Time frame: Through study recruitment and all data collection, an average of 2 years.
Outcome measure: Information will be collected on: 1. The number of patients screened, eligible and approached. 2. The percentage of patients that: A) Decline the biofeedback intervention (including reasons for declining). B) Agree to the biofeedback intervention. C) Consent to being part of the study. 3. The percentage of patients that take up the biofeedback intervention and reasons for drop out. 4. The percentage of participants that complete outcome assessments and reasons for drop out. 5. The percentage time individuals wear the devices.
22 secondary outcomes
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
Time frame: Immediately after the 3-week usability testing iterations
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
Time frame: During each 3-week usability testing period.
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
Time frame: Through study recruitment and data collection, an average of 4 months
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
Time frame: Immediately after the first 3-week usability testing iteration.
Phase 1: Quantify the time taken and resources required to produce nudges to gain an understanding of the maximum potential active intervention participants that can be simultaneously ongoing in Phase-2 feasibility RCT
Time frame: Through study recruitment and data collection, an average of 4 months
Phase 1: Investigate the validity and quantify the error of the Polar Pacer smartwatch HRV data against a clinical-grade Holter monitor, or the Polar H10 chest strap.
Time frame: First 24-hour periprocedural period.
Phase 1: Investigate the reliability and quantify the error of the Polar Pacer activity score as a measurement of PA against the GENEactiv wrist-based accelerometer
Time frame: First 7-days of periprocedural period.
Phase 2: 2) Evaluate the acceptability of the intervention to patients, assessing the feasibility of delivering the biofeedback intervention to patients with paroxysmal AF
Time frame: Within 1 month of completing all 6-month post-intervention data collection.
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer steps additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent sleeping additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent sitting additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent standing additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent in light activity additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent in moderate activity additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer time spent in vigorous activity additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer calories additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer total METs additionally measured throughout 6-month intervention).
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention)
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention)
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention)
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention)
Phase 2: Assess the suitability of outcome measures for future full-scale RCT.
Time frame: 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer HRV additionally measured throughout 6-month intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback intervention in people with Atrial Fibrillation (Paroxysmal), 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 11 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca J Howard (+ 151 231 2121, l.j.howard@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Co-design biofeedback nudges and report content, layout and the optimal time/frequency of nudges. Underpinned by a double diamond framework, through an iterative co-design process. (time frame: Immediately after the 3-week usability testing iterations.). 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?
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 22 May 2026.