Concurrent Training in Patients Undergoing Atrial Fibrillation Ablation.

NCT06832033 | Recruiting

• 1 other identifier: PI24/174
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is an irregular and often very fast heart rhythm, is considered the most common sustained cardiac arrhythmia in adults worldwide, and its incidence and prevalence are increasing. Currently, the estimated prevalence of AF in adults is 2-4%, and is projected to increase 2.3-fold. AF is associated with increased morbimortality and other comorbidities (hypertension diabetes etc.) which places a significant burden on the patient himself, social health and also on health and social care expenditure. The European Society of Cardiology proposes an integrated ABC model (A: Anticoagulation, B: main symptom management, C: optimization of comorbidities and cardiovascular) and within this model, catheter ablation (B) is considered one of the main treatments to control AF symptoms; physical activity (C) is considered one of the modifiable health risk factors and is considered within a lifestyle intervention together with weight loss. Catheter ablation of AF is currently the treatment of choice for paroxysmal AF. It uses small burns or frostbite to cause some scarring inside the heart to help interrupt the electrical signals that cause the irregular heartbeat. It is a safe procedure that has been shown to be more effective than treatment with antiarrhythmic drugs in reducing the arrhythmic burden and, therefore, the morbidity and mortality associated with the pathology. Many studies have demonstrated the beneficial effects of moderate physical activity and physical exercise on cardiovascular health. However, there is still controversy as to whether physical activity is associated with an increased risk of AF in the general population; while some studies report a decreased risk of AF, others suggest an increase or that there is no evidence of an association between AF and physical activity. Few studies have yet focused on the effects of physical activity in those subjects who have undergone catheter ablation. Studies that have evaluated physical activity with questionnaires associate it, when of moderate or high intensity, with lower recurrence of AF and lower incidence of serious events. It is true that the practice of regular and controlled physical exercise is a recognized part of the comprehensive care of patients with coronary heart disease (patients whose heart has difficulty receiving blood), and exercise is systematically identified as a central element of their rehabilitation. However, to date there is no similar approach for AF ablation patients. Given the current situation of the subject of interest, the main objective of this project is to study the influence of a physical exercise program in patients undergoing catheter ablation of AF on different morphological and physiological variables of the heart, levels of physical activity and quality of life of patients. Investigators intend to recruit 120 participants, who will be randomly and equally distributed into a group that will perform a physical exercise intervention and a control group that will not perform any type of intervention. Participation in the study will not disrupt the normal practice of the health care system with these patients.

Conditions

Atrial Fibrillation (AF); Physical Exercise; Physical Activity; Physical Fitness; Sleep; Quality of Life; Electrocardiogram; Echocardiogram

Outcome Measures

Primary Outcomes (3)

• Atrial fibrillation burden

  By subcutaneously implanting an insertable Holter device, the exact time in AF can be accurately quantified, since this type of device continuously monitors the heart rhythm throughout its battery life (3 years). This allows all subclinical and clinical AF episodes and their duration to be recorded.

  6 months

• Echocardiogram

  It will be performed by a single observer with a Vivid iQ model echocardiograph following the latest recommendations.

  6 months

• Cardiorespiratory capacity

  A 6-minute walking test will be performed to assess the subjects' cardiorespiratory capacity.

  6 months

Secondary Outcomes (10)

• Body composition

  6 months

• Body composition

  6 months

• Electrocardiogram (ECG)

  6 months

• Electrocardiogram (ECG)

  6 months

• Electrocardiogram (ECG)

  6 months

Study Arms (2)

Control group

NO INTERVENTION

Training group

ACTIVE COMPARATOR

This group carried out a concurrent physical exercise intervention for 12 weeks

Other: Exercise

Interventions

Exercise OTHER

12 weeks of concurrent training, which is understood as a combination of strength and aerobic exercises, not necessarily in the same training session. The weekly frequency will be 3 times per week. The aerobic component of the session will last between 30 and 50 minutes (increasing as the weeks go by) and the strength work will be made up of 8 exercises (3 upper body and 5 lower body). The intensity of the training will be individualized and always moderate.

Also known as: Concurrent training, Physical exercise

Training group

Eligibility Criteria

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

You may qualify if:

• Patients aged ≥18 years
• Undergoing catheter ablation as medical treatment for AF at least one year prior to enrollment.

You may not qualify if:

• Patients who do not sign the informed consent for participation in the study.
• Severe atrial dilatation.
• Structural heart disease.
• Pathology that prevents the normal practice of intervention with physical exercise

Sponsors & Collaborators

• Marcos Echevarría: lead

Study Sites (1)

University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Marcos Echevarría Polo, PhD Student

CONTACT

+34 640554122; mechevarria@unizar.es

Nuria Garatachea Vallejo, PhD

CONTACT

+34 606777435; nugarata@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 18, 2025
• Study Start: September 9, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-01

Locations

ES (1)