High-intensity Interval Training in Patients With Atrial Fibrillation

NCT05354271 | Unknown

• 1 other identifier: 21LJMUSPONSOR060
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atrial Fibrillation

Keywords

Exercise training; High-intensity interval training; Cardiovascular function; Atrial fibrillation burden; Secondary prevention; Aerobic training

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and 3 months post rhythm control procedure

Secondary Outcomes (13)

• Maximal oxygen uptake

  baseline and 3 months post rhythm control procedure

• Peripheral endothelial function

  baseline and 3 months post rhythm control procedure

• Carotid structure

  baseline and 3 months post rhythm control procedure

• Central endothelial function

  baseline and 3 months post rhythm control procedure

• Health related quality of life

  baseline and 3 months post rhythm control procedure

Study Arms (3)

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.

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).

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.

Interventions

High-intensity interval training OTHER

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.

High-intensity interval training

Moderate-intensity continuous training OTHER

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).

Moderate-intensity continuous training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of non-permanent AF
• \> 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Liverpool Heart and Chest Hospital NHS Foundation Trust: collaborator
• Liverpool Centre for Cardiovascular Science: collaborator
• University of Liverpool: collaborator

Study Sites (1)

Liverpool Centre for Cardiovascular Sciences

Liverpool, Merseyside, L14 3PE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: April 29, 2022
• Study Start: August 27, 2021
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: April 29, 2022

Record last verified: 2021-11

Locations

GB (1)