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| Name | Class |
|---|---|
| University of Bath | OTHER |
| University of Oxford | OTHER |
| Biotronik SE & Co. KG | INDUSTRY |
| RUHX (Official NHS Charity for RUH Bath) |
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This study proposes to evaluate the effectiveness of a novel lifestyle intervention (Super Rehab), in addition to standard care, for patients with symptomatic atrial fibrillation (AF) requiring rhythm control strategy who are overweight.
As the main driver behind the selection of a rhythm-control strategy for patients with AF, the primary outcome will be an improvement in AF-related symptoms with Super Rehab versus Usual Care only. Secondary outcomes will include the burden of AF, biochemical and cardiac functional and structural changes, and markers of quality-of-life and health resource use.
In this randomised controlled trial (RCT) the investigators will study the efficacy of a novel lifestyle intervention (Super Rehab), in addition to usual care, for patients with symptomatic atrial fibrillation (AF) where are a rhythm-control strategy is being employed who are overweight. Increasing evidence has shown that AF can respond to robust lifestyle change and aggressive risk factor modification, and in some case can in fact regress.
In the majority of cases, the decision to target a rhythm-control strategy for AF is based on the symptom-burden reported by the patient. This in light of the low volume of evidence suggesting any benefits of rhythm-control strategies over rate-control strategies based on prognostic clinical outcomes.
The modifiable cardiovascular (CV) risk factors that increase both CV risk and the frequency of its various forms of disease also impact the development and progression of AF. In addition, patients with multiple CV risk factors are at enhanced risk of both poorer long-term outcomes and earlier failures of traditional rhythm-control strategies.
This RCT study will involve patients who have described symptomatic AF such that their treating team have elected for a rhythm-control strategy (i.e. a combination of anti-arrhythmic therapy ± a referral for a direct current (DC) cardioversion and/or an ablation) who are also overweight (body mass index [BMI] ≥27kg/m2). The BMI criterion acts as a marker of CV risk that may respond to a lifestyle intervention, which has proved sensitive in other studies.
Participants will be randomised to either Super Rehab and Usual Care or to continue Usual Care only. Super Rehab includes a combination of 1:1 supervised high-intensity exercise, dietary advice sessions and 3-monthly clinical reviews to optimise CV risk factor management. The whole programme lasts 12 months. Participants in both arms will undergo imaging, fitness, clinical tests (including blood tests), and complete questionnaires on four occasions during the study.
The primary outcome of the study will assess the difference in AF symptom burden between the two groups. In addition, the study will assess important secondary outcomes that include change in AF burden (i.e. the amount of time spent in AF), quality-of-life and well-being, biochemical, anthropometric, blood pressure and cardiac functional and structural changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Patients will continue Usual Care, which will include having medication optimised for adequate heart-rate control, anti-arrhythmic therapy, and anti-coagulation (for stroke-risk) instituted by their treating Cardiologist if indicated by their CHAâ‚‚DSâ‚‚-VASc Score. Patients who remain significantly symptomatic despite attempts to optimise medical therapy may be referred for further rhythm management strategies, including cardioversion(s) and/or ablation(s) - as per current standard clinical practice. The Cardiologist will also provide routine, verbal one-off lifestyle advice in line with guidance. | |
| Super Rehab plus Usual Care | Experimental | 12-month Super Rehab programme involving supervised dietary review sessions, 1-to-1 high-intensity exercise sessions and 3-monthly clinical review of AF risk factors, alongside Usual Care (defined above) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super Rehab | Behavioral | A 12-month healthcare-delivered lifestyle intervention involving exercise, nutritional support and optimisation of AF-related clinical risk factors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom burden, as defined by the University of Toronto Atrial Fibrillation Severity Scale (AFSS) | As the primary outcome, an atrial fibrillation-specific measure of symptoms and quality of life will be assessed using the University of Toronto Atrial Fibrillation Severity Scale (AFSS) questionnaire. Scores range from 0 to 35, with higher scores indicating greater AF symptom severity. Differences between groups will be assessed at 12 months, with additional assessments conducted and reported at 6- and 15-month time points. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| % burden of AF | Differences between groups of the AF burden - defined as the duration of time spent in atrial fibrillation, as assessed via implantable cardiac monitor (ICM) - will be assessed at 12 months, with additional measurements conducted and reported at 6- and 15-month time points. | Month 12 |
| Duration and number of AF episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Khavandi | Royal United Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal United Hospitals Bath NHS Foundation Trust | Bath | BA1 3NG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953861 | Derived | Murphy D, Graby J, Smith T, Peacock O, Abramik J, Antoniades C, Rodrigues JCL, Thompson D, Khavandi A. Effectiveness of a novel intervention (Super Rehab) in overweight patients with atrial fibrillation (SuRe AF): protocol for a randomised controlled trial. BMJ Open. 2025 Sep 14;15(9):e103090. doi: 10.1136/bmjopen-2025-103090. |
| Label | URL |
|---|---|
| Research team website outlining research goals | View source |
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Requests for data sharing will be reviewed on an individual basis upon request to the research team.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D050177 | Overweight |
| D009765 | Obesity |
| D040242 | Risk Reduction Behavior |
| D009043 | Motor Activity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| UNKNOWN |
Patients randomized to Usual Care or Super Rehab plus Usual Care
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It is not possible to blind either the participant or care providers to their study arm, however the outcome analysis will be undertaken blinded to study arm
Differences between groups in AF duration and frequency will be assessed at 12 months, via implantable cardiac monitor (ICM), with additional measurements conducted and reported at 6- and 15-month time points. |
| Month 12 |
| Time to first arrhythmia recurrence | Defined as the time from normal rhythm to the earliest documented date of AF, recorded via implantable cardiac monitor (ICM), following a DCCV or ablation where ICM data was available prior to the intervention. | Month 12 |
| Anthropometrics - Body weight | Change in weight between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points. | 12 months |
| Anthropometrics - body mass index | Change in body mass index (BMI) between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- 15-month time points. | Month 12 |
| Anthropometrics - abdominal waist circumference | Change in abdominal waist circumference between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- 15-month time points. | Month 12 |
| Cardiorespiratory fitness | Differences between groups of the measured maximum rate of oxygen consumption attainable during physical exertion (VO2 peak) will be assessed via cardio pulmonary exercise test (CPET) at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points: | Month 12 |
| Visceral fat | Differences between groups of the measured visceral fat will be assessed at 12 months (via DEXA body composition scan), with additional evaluations conducted and reported at 6- and 15-month time points. | Month 12 |
| Cardiac structural and functional assessment with echocardiography | Change in left atrial size and strain between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points. | Month 12 |
| CTCA based changes in left atrial structure | Differences in peri-atrial fat volume and inflammatory signal - assessed by cardiac CT - will be evaluated between groups at 12 months | Month 12 |
| Blood pressure control | Differences between groups in both systolic and diastolic BP control, using a 7-day home blood pressure diary, will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points. | Month 12 |
| Serum lipid levels | Differences between groups in serum lipid levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points. | Month 12 |
| Glucose control (HbA1c) | Differences between groups in serum HbA1c levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points. | Month 12 |
| Inflammatory marker (high-sensitivity C-reactive protein) | Differences between groups in serum CRP levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points. | Month 12 |
| Physical activity | Differences in physical activity between groups, as defined by the implantable cardiac monitor (ICM), will be assessed at 12 months with additional evaluations conducted and reported at 6- and 15-month time points. | 12 months |
| European Heart Rhythm Association (EHRA) AF-score | The EHRA AF scale ranges from 1 (no symptoms) to 4 (disabling symptoms). Differences between groups will be assessed at 12 months with additional evaluations conducted and reported at the 6- and 15 month time points. | Month 12 |
| Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire | The AFEQT questionnaire involves responses to a 20-item questionnaire that are scored on a 1 to 7 Likert scale (ranging from 1: "Not at all" to 7: "Extremely"). The four subscales of AFEQT are: Symptoms, Daily activities, Treatment concern and Treatment satisfaction. Overall and subscale scores range from 0 for worst to 100 for best quality of life. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points. | Month 12 |
| EuroQol Group (EuroQol) EQ-5D-5L questionnaire | Patient reported health-related quality-of-life will be recorded using the EuroQol EQ-5D-5L questionnaire. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points. | Month 12 |
| Hospital Anxiety and Depression Scale (HADS) | Hospital Anxiety and Depression Scale (HADS) questionnaire. Scores range from 0 to 21 with higher scores reflecting a higher degree of anxiety and/or depression. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at the 6- and 15-month time points. | Month 12 |
| ICEpop CAPability measure for Adults (ICECAP-A) | The ICEpop CAPability measure for Adults (ICECAP-A) will assess holistic capability changes over time as part of a health economic assessment. Scores range from 5 to 20, with higher scores reflecting higher levels of capability. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at the 6- and 15-month time points. | Month 12 |
| Resource-use questionnaire | A study-specific resource-use questionnaire will record health economic parameters including medication burden, primary and secondary care interactions, impact of AF on work status, and smoking status. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points. | Month 12 |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |