Atrial FibrillationHIIT-AFNCT05354271
High-intensity Interval Training in Patients With Atrial Fibrillation
A study testing High-intensity interval training and Moderate-intensity continuous training in people with Atrial Fibrillation, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
A key characteristic of the heart is its regular rhythm. When the heart is exposed to irregular electric impulses, such as with atrial fibrillation (AF), detrimental effects can occur affecting the ability of the heart to pump blood. 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?
- High-intensity interval training and Moderate-intensity continuous training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Aug 2021to 27 Jan 2023
- 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
- Presence of non-permanent AF
- > 18 years old
Who cannot join
- Performing endurance training at high intensity >2 times/week or at moderate intensity >3 times/week;
- Previous cardiac surgery not related to AF;
- LVEF <45%;
- Severe coronary artery disease non-suitable for revascularization;
- Significant cardiac valve disease;
- Implanted cardiac pacemaker;
- And restriction to cardiopulmonary exercise testing or severe intolerance to exercise.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool Centre for Cardiovascular Sciences
Liverpool, Merseyside, L14 3PE
Maxime Boidin, PhD, 0151 600 1223 ext. 1223, maxime.boidin@lhch.nhs.uk
About this study
Official title: Impact of High-intensity Interval Training in Patients With Atrial Fibrillation: Understanding of the Underlying Cardiovascular Mechanisms
A key characteristic of the heart is its regular rhythm. When the heart is exposed to irregular electric impulses, such as with atrial fibrillation (AF), detrimental effects can occur affecting the ability of the heart to pump blood. AF affects more than 33 million individuals worldwide, and places individuals at increased risk for stroke, heart failure and death. Of note, being fit seems to protect the long-term severity of AF, and individuals with AF who improved their aerobic fitness seem to decrease their severity of atrial fibrillation. Although exercise training is known to improve aerobic fitness, there are limited data investigating the benefits of an exercise training program on the reduction of AF burden.
Once AF is present, regular exercise in these patients reduces the risk for developing cardiovascular events. Moreover, exercise training at high-intensity seems to bring greater adaptations in cardiac patients. This effect may be related to improvements in cardiovascular function and structure. No previous study has explored this possibility in patients with AF. Therefore, I will assess cardiac function and blood vessel quality before and after exercise training (at high- and moderate-intensities) in patients with AF. Better insight into how intensity of exercise training could affect the heart and the blood vessels can lead to better exercise recommendations in this population.
This project will contribute to improved clinical care for patients with AF, specifically related to the prescription of the optimal dose and type of exercise. This may result in fewer complications, improved quality of life, and lower socio-economic/healthcare costs.
Read the detailed description
Atrial fibrillation (AF) is the most common clinically significant arrhythmia, affecting more than 33 million individuals worldwide. AF leads to structural and electrical remodeling in both the atria and ventricles and is strongly related to an increased risk of stroke, heart failure and death. The CARDIO-FIT study demonstrated that AF patients with a higher baseline aerobic fitness were almost 3 times more likely to maintain arrhythmia freedom after a 4-year follow-up; also, AF patients who gained more than 2 metabolic equivalents (METs, aerobic fitness) were more than two-fold more likely to maintain sinus rhythm.
High-intensity exercise training and atrial fibrillation. Each METs gained was associated with a 9% decline in the risk of arrhythmia recurrence. From studies performed in patients with cardiovascular disease, high-intensity interval training (HIIT) seems to bring at least similar or greater improvements in aerobic fitness compared to a moderate-intensity continuous training (MICT). Moreover, in patients with AF, time in AF was reduced of -3.3±7.2% after 12 weeks of HIIT compared to an increased time in AF of 4.2±11.8% in a control group without exercise. Whilst this highlights the potency of HIIT, no previous study has directly compared the effects of HIIT vs. MICT in AF patients on AF burden.
Cardiovascular physiological mechanism(s). Patients with AF exhibit cardiac and vascular dysfunction. However, exercise training improves cardiac and vascular function in human, but the effects are unknown in AF patients. This knowledge is important to improve management of patients with AF with an optimal training prescription. Research on long-term effects and safety related to high-intensity exercise in AF patients is therefore warranted. The findings of the optimal training prescription will help us to update and improve the current guidelines.
Building on the latest scientific insights, the overall aim of this proposal is to determine the optimal intensity for reducing the AF burden. Moreover, the understanding of the underlying mechanisms could help us to determine the cardiovascular adaptations related to exercise training (HIIT or MICT).
Taken together, this study will answer these two questions:
- What is the best exercise intensity for reducing the time in AF?
- What are the underlying cardiovascular mechanisms associated with any training related decrease in AF burden? Objectives. Objective 1. High-intensity interval training and AF: The investigators will compare the effects of HIIT and MICT on the burden of AF to test the hypothesis that HIIT decreases the time in AF to a greater extent than MICT.
Objective 2. Cardiovascular physiological mechanisms: The investigators will assess cardiovascular function in all AF patients before and after the training intervention, to test the hypothesis that HIIT is associated with greater cardiovascular adaptation compared to MICT.
Methods. Experimental design: The investigators will perform a 3-arm randomised controlled trial to answer the first research question. The investigators will compare regular care (control group) with regular care + HIIT and regular care + MICT in a total of 60 stable outpatients with non-permanent AF in need for rhythm control (catheter ablation or cardioversion) on the pre-procedure burden of AF, and post-procedure recurrence. When participants are listed on the waiting list for the ablation procedure, they will be assigned to control or HIIT or MICT in a randomized order. The waiting list is approximately 3 months, so patients would have the exercise program for at least 3 months prior to the rhythm control procedure, and continue for 3 months post-procedure to assess AF recurrence. To answer the second research question, the investigators will perform cardiac and vascular functions measurements at baseline, 3 months, and 6 months training intervention in all patients.
- Conditions
- Atrial Fibrillation
- Being tested
- High-intensity interval training, Moderate-intensity continuous training
- Keywords
- Exercise training, High-intensity interval training, Cardiovascular function, Atrial fibrillation burden, Secondary prevention, Aerobic training
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
Patients will cycle or walk/run four intervals of four-min at high intensity with the aim to reach 80-90% of peak oxygen consumption, 90-95% of peak heart rate, 15-17 Borg scale, shortness of breath). Each interval is separated by a three-min active recovery, at 50-60% of peak oxygen consumption or 70-75% of peak heart rate. Total exercise time will be 38 min including the warm-up and cool-down.
Moderate-intensity continuous trainingOther
Patients will cycle or walk/run continuously at moderate intensity (50-60% of peak oxygen consumption, 70-75% of peak heart rate) for 37 min. Total exercise time will be 47 min for the Moderate-intensity continuous training group including warm-up and cool-down (isoenergetic compared to high-intensity interval training).
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | Patients will cycle or walk/run four intervals of four-min at high intensity with the aim to reach 80-90% of peak oxygen consumption, 90-95% of peak heart rate, 15-17 Borg scale, shortness of breath). Each interval is separated by a three-min active recovery, at 50-60% of peak oxygen consumption or 70-75% of peak heart rate. Total exercise time will be 38 min including the warm-up and cool-down. Receives: Other: High-intensity interval training |
| Moderate-intensity continuous training | Active comparator | Patients will cycle or walk/run continuously at moderate intensity (50-60% of peak oxygen consumption, 70-75% of peak heart rate) for 37 min. Total exercise time will be 47 min for the moderate-intensity continuous training group including warm-up and cool-down (isoenergetic compared to high-intensity interval training). Receives: Other: Moderate-intensity continuous training |
| Control | No intervention | The control group will continue their habits without increasing the level of physical activity nor participate to any supervised exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in burden of atrial fibrillation
Burden of atrial fibrillation (number of episodes) continually measured, and reported by the patient. Measured by Huawei Band 4 and 6
Measured: baseline and 3 months post rhythm control procedure
Secondary outcomes (13)
Maximal oxygen uptake
VO2peak
Measured: baseline and 3 months post rhythm control procedure
Peripheral endothelial function
FMD
Measured: baseline and 3 months post rhythm control procedure
Carotid structure
IMT
Measured: baseline and 3 months post rhythm control procedure
Central endothelial function
CAR
Measured: baseline and 3 months post rhythm control procedure
Health related quality of life
Measured with the Medical Outcome Survey Short Form-36 (SF-36) questionnaire
Measured: baseline and 3 months post rhythm control procedure
Health related quality of life
Measured with the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
Measured: baseline and 3 months post rhythm control procedure
Health related quality of life
Measured with the modified Mayo AF-Specific Symptom Inventory (mMAFSI) questionnaire
Measured: baseline and 3 months post rhythm control procedure
Health related quality of life
Measured with the HeartQoL questionnaire
Measured: baseline and 3 months post rhythm control procedure
Physical activity level
Steps, sedentary time, light (< 3 METs), moderate (3-<6 METs) and vigorous (≥6 METS) physical activities, measured with the Huawei bands for 14 nights and days (24h)
Measured: baseline and 3 months post rhythm control procedure
Resting atrial and ventricular function
Atrial and ventricular function including left ventricular function, volume, dimension of the cavities, wall thickness, blood and tissue velocities measured by echocardiography
Measured: baseline and 3 months post rhythm control procedure
Myocardial strain
GLS, circumferential and radial strain measured by echocardiography
Measured: baseline and 3 months post rhythm control procedure
Strain-area loop
Relation between changes in volume and strain measured by echocardiography
Measured: baseline and 3 months post rhythm control procedure
Atrial and ventricular function during exercise
Atrial and ventricular function including left ventricular function, volume, dimension of the cavities, wall thickness, blood and tissue velocities measured by echocardiography during exercise
Measured: baseline and 3 months post rhythm control procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start27 Aug 2021
- Primary completion27 Jan 2023 (estimated)
- Study completion27 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 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, Liverpool Centre for Cardiovascular Science, University of Liverpool
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354271
- Sponsor's protocol ID
- 21LJMUSPONSOR060
- Acronym
- HIIT-AF
- Status last verified
- Nov 2021
- First submitted
- 2 Dec 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is the first training intervention study in our Lab, so we haven't decided yet and it could be an option if other training studies are conducted.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High-intensity Interval Training in Patients With Atrial Fibrillation: Understanding of the Underlying Cardiovascular Mechanisms
- ClinicalTrials.gov ID
- NCT05354271
- Acronym / sponsor ID
- HIIT-AF / 21LJMUSPONSOR060
- Conditions
- Atrial Fibrillation
- Keywords
- Exercise training, High-intensity interval training, Cardiovascular function, Atrial fibrillation burden, Secondary prevention, Aerobic training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool Centre for Cardiovascular Science, University of Liverpool
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 27 Jan 2023 (estimated)
- Study completion
- 27 Jan 2023 (estimated)
- First posted
- 29 Apr 2022 (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.
A key characteristic of the heart is its regular rhythm. When the heart is exposed to irregular electric impulses, such as with atrial fibrillation (AF), detrimental effects can occur affecting the ability of the heart to pump blood. AF affects more than 33 million individuals worldwide, and places individuals at increased risk for stroke, heart failure and death. Of note, being fit seems to protect the long-term severity of AF, and individuals with AF who improved their aerobic fitness seem to decrease their severity of atrial fibrillation. Although exercise training is known to improve aerobic fitness, there are limited data investigating the benefits of an exercise training program on the reduction of AF burden.
Once AF is present, regular exercise in these patients reduces the risk for developing cardiovascular events. Moreover, exercise training at high-intensity seems to bring greater adaptations in cardiac patients. This effect may be related to improvements in cardiovascular function and structure. No previous study has explored this possibility in patients with AF. Therefore, I will assess cardiac function and blood vessel quality before and after exercise training (at high- and moderate-intensities) in patients with AF. Better insight into how intensity of exercise training could affect the heart and the blood vessels can lead to better exercise recommendations in this population.
This project will contribute to improved clinical care for patients with AF, specifically related to the prescription of the optimal dose and type of exercise. This may result in fewer complications, improved quality of life, and lower socio-economic/healthcare costs.
Detailed description
Atrial fibrillation (AF) is the most common clinically significant arrhythmia, affecting more than 33 million individuals worldwide. AF leads to structural and electrical remodeling in both the atria and ventricles and is strongly related to an increased risk of stroke, heart failure and death. The CARDIO-FIT study demonstrated that AF patients with a higher baseline aerobic fitness were almost 3 times more likely to maintain arrhythmia freedom after a 4-year follow-up; also, AF patients who gained more than 2 metabolic equivalents (METs, aerobic fitness) were more than two-fold more likely to maintain sinus rhythm.
High-intensity exercise training and atrial fibrillation. Each METs gained was associated with a 9% decline in the risk of arrhythmia recurrence. From studies performed in patients with cardiovascular disease, high-intensity interval training (HIIT) seems to bring at least similar or greater improvements in aerobic fitness compared to a moderate-intensity continuous training (MICT). Moreover, in patients with AF, time in AF was reduced of -3.3±7.2% after 12 weeks of HIIT compared to an increased time in AF of 4.2±11.8% in a control group without exercise. Whilst this highlights the potency of HIIT, no previous study has directly compared the effects of HIIT vs. MICT in AF patients on AF burden.
Cardiovascular physiological mechanism(s). Patients with AF exhibit cardiac and vascular dysfunction. However, exercise training improves cardiac and vascular function in human, but the effects are unknown in AF patients. This knowledge is important to improve management of patients with AF with an optimal training prescription. Research on long-term effects and safety related to high-intensity exercise in AF patients is therefore warranted. The findings of the optimal training prescription will help us to update and improve the current guidelines.
Building on the latest scientific insights, the overall aim of this proposal is to determine the optimal intensity for reducing the AF burden. Moreover, the understanding of the underlying mechanisms could help us to determine the cardiovascular adaptations related to exercise training (HIIT or MICT).
Taken together, this study will answer these two questions:
- What is the best exercise intensity for reducing the time in AF?
- What are the underlying cardiovascular mechanisms associated with any training related decrease in AF burden? Objectives. Objective 1. High-intensity interval training and AF: The investigators will compare the effects of HIIT and MICT on the burden of AF to test the hypothesis that HIIT decreases the time in AF to a greater extent than MICT.
Objective 2. Cardiovascular physiological mechanisms: The investigators will assess cardiovascular function in all AF patients before and after the training intervention, to test the hypothesis that HIIT is associated with greater cardiovascular adaptation compared to MICT.
Methods. Experimental design: The investigators will perform a 3-arm randomised controlled trial to answer the first research question. The investigators will compare regular care (control group) with regular care + HIIT and regular care + MICT in a total of 60 stable outpatients with non-permanent AF in need for rhythm control (catheter ablation or cardioversion) on the pre-procedure burden of AF, and post-procedure recurrence. When participants are listed on the waiting list for the ablation procedure, they will be assigned to control or HIIT or MICT in a randomized order. The waiting list is approximately 3 months, so patients would have the exercise program for at least 3 months prior to the rhythm control procedure, and continue for 3 months post-procedure to assess AF recurrence. To answer the second research question, the investigators will perform cardiac and vascular functions measurements at baseline, 3 months, and 6 months training intervention in all patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Other: High-intensity interval trainingPatients will cycle or walk/run four intervals of four-min at high intensity with the aim to reach 80-90% of peak oxygen consumption, 90-95% of peak heart rate, 15-17 Borg scale, shortness of breath). Each interval is separated by a three-min active recovery, at 50-60% of peak oxygen consumption or 70-75% of peak heart rate. Total exercise time will be 38 min including the warm-up and cool-down. |
| Moderate-intensity continuous training | Active comparator | Other: Moderate-intensity continuous trainingPatients will cycle or walk/run continuously at moderate intensity (50-60% of peak oxygen consumption, 70-75% of peak heart rate) for 37 min. Total exercise time will be 47 min for the moderate-intensity continuous training group including warm-up and cool-down (isoenergetic compared to high-intensity interval training). |
| Control | No intervention | –The control group will continue their habits without increasing the level of physical activity nor participate to any supervised exercise training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of non-permanent AF
- > 18 years old
Key exclusion criteria (7 listed)
- Performing endurance training at high intensity >2 times/week or at moderate intensity >3 times/week;
- Previous cardiac surgery not related to AF;
- LVEF <45%;
- Severe coronary artery disease non-suitable for revascularization;
- Significant cardiac valve 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 |
|---|---|---|
| High-intensity interval trainingPatients will cycle or walk/run four intervals of four-min at high intensity with the aim to reach 80-90% of peak oxygen consumption, 90-95% of peak heart rate, 15-17 Borg scale, shortness of breath). Each interval is separated by a three-min active recovery, at 50-60% of peak oxygen consumption or 70-75% of peak heart rate. Total exercise time will be 38 min including the warm-up and cool-down. | Other | High-intensity interval training |
| Moderate-intensity continuous trainingPatients will cycle or walk/run continuously at moderate intensity (50-60% of peak oxygen consumption, 70-75% of peak heart rate) for 37 min. Total exercise time will be 47 min for the Moderate-intensity continuous training group including warm-up and cool-down (isoenergetic compared to high-intensity interval training). | Other | Moderate-intensity continuous training |
Primary outcome
Change in burden of atrial fibrillation
Time frame: baseline and 3 months post rhythm control procedure
Burden of atrial fibrillation (number of episodes) continually measured, and reported by the patient. Measured by Huawei Band 4 and 6
13 secondary outcomes
Maximal oxygen uptake
Time frame: baseline and 3 months post rhythm control procedure
Peripheral endothelial function
Time frame: baseline and 3 months post rhythm control procedure
Carotid structure
Time frame: baseline and 3 months post rhythm control procedure
Central endothelial function
Time frame: baseline and 3 months post rhythm control procedure
Health related quality of life
Time frame: baseline and 3 months post rhythm control procedure
Health related quality of life
Time frame: baseline and 3 months post rhythm control procedure
Health related quality of life
Time frame: baseline and 3 months post rhythm control procedure
Health related quality of life
Time frame: baseline and 3 months post rhythm control procedure
Physical activity level
Time frame: baseline and 3 months post rhythm control procedure
Resting atrial and ventricular function
Time frame: baseline and 3 months post rhythm control procedure
Myocardial strain
Time frame: baseline and 3 months post rhythm control procedure
Strain-area loop
Time frame: baseline and 3 months post rhythm control procedure
Atrial and ventricular function during exercise
Time frame: baseline and 3 months post rhythm control procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided. It is the first training intervention study in our Lab, so we haven't decided yet and it could be an option if other training studies are conducted.
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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.
Liverpool Centre for Cardiovascular Sciences
Liverpool, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Moderate-intensity continuous training 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 2 inclusion and 7 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 29 Apr 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in burden of atrial fibrillation (time frame: baseline and 3 months post rhythm control procedure). 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 29 Apr 2022.