Concurrent Training in Patients Undergoing Atrial Fibrillation Ablation.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarcos Echevarría

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 years

Undergoing catheter ablation as medical treatment for AF at least one year prior to enrollment.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Training groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

Echocardiogram

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

Time frame
6 months
3

Cardiorespiratory capacity

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

Time frame
6 months

Secondary outcomes

1

Body composition

Bioimpedance. A bioimpedance analyzer (TANITA MC-780) will be used to estimate fat mass.

Time frame
6 months
2

Body composition

Bioimpedance. A bioimpedance analyzer (TANITA MC-780) will be used to estimate fat-free mass (muscle and bone mass).

Time frame
6 months
3

Electrocardiogram (ECG)

Description and study of the ECG P wave, obtained from both single leads and combined information from multiple leads.

Time frame
6 months
4

Electrocardiogram (ECG)

Study of heart rate variability (HRV) from the index of standard deviation of NN intervals (SDNNN).

Time frame
6 months

Other outcomes

Sponsors and contacts

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Marcos Echevarría

Lead sponsor

Universidad de Zaragoza

Sponsor institution