Exercise Effects on Atrial Fibrillation
ConditionAtrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEuropean University Miguel de Cervantes
About this trial
Atrial fibrillation (AF) significantly affects quality of life and increases the demand for medical care of those affected. It is very important to identify triggering factors, such as oxidative stress or N-terminal pro-B-type natriuretic peptide (NT-proBNP), as well as to identify potential biomarkers through plasma analysis. At the same time, it is essential to establish adequate training and rehabilitation programs, which would result in a decrease in hospitalizations and the health care costs associated with the pathology. Current cardiac rehabilitation programs based on physical exercise, especially moderate intensity continuous training (MICT), have demonstrated effectiveness. MICT improves cardiorespiratory fitness and quality of life in patients with AF. However, high-intensity intervallic training (HIIT) has shown superior benefits in these variables.
Although HIIT traditionally has an aerobic focus, a variant called high-intensity functional training (HIFT) is suggested that incorporates muscle strengthening exercises recommended in the guidelines for AF management. This innovative modality seeks to achieve cardiovascular and neuromuscular adaptations simultaneously, with a high transfer to daily activities. Despite its potential, the effects at the functional, molecular and clinical levels in patients with AF are unknown. The purpose of the study is to determine the benefits of HIFT on molecular, functional and clinical variables in patients with AF, and to compare these benefits with those achieved with HIIT and the usual care and recommendations in current clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Paroxysmal or persistent atrial fibrillation.
Age between 18 and 80 years.
Sedentary lifestyle.
Signed informed consent.
Disqualifiers
Permanent atrial fibrillation.
Moderate to severe left ventricular dysfunction.
Moderate to severe left valvulopathy.
Severe pulmonary hypertension.
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental HIIT
Other interventionSubjects belonging to this group perform a 12-week supervised exercise (3 sessions weekly spaced at least 48 hours apart with a maximum duration of 40 minutes), followed by 12 weeks of detraining follow-up. Before starting the intervention, two familiarization sessions for assessing strength and functional capacity will be conducted. This program is designed in a standardized warm-up: joint mobility exercises and neuromuscular activation (5 minutes). Main part os the training is design in treadmill walking exercise (28 minutes). Participants must complete four four-minute blocks at an intensity of 85-95% of peak heart rate.The initial starting speed is 5 km/h and adjust the intensity with incline increments of 2%. Between sets, a prescribed active rest period lasts three minutes, during which patients walk on the treadmill at an intensity of 60-70% of peak heart. The last part of the training is a cool-down (5 minutes treadmill walking at an intensity of 50-60% of peak heart rate).
Experimental HIFT
Other interventionSubject belonging to this group perform a 12-week supervised exercise (3 sessions weekly spaced at least 48 hours apart with a maximum duration of 40 minutes), followed by 12 weeks of detraining follow-up. Before starting the intervention, two familiarization sessions for assessing strength and functional capacity will be conducted. AMRAP will consist of a circuit of six global, functional exercises with external loads \[i) squat; ii) rowing; iii) dead weight; iv) chest press; v) step up; vi) farmer walk\]. Patients will perform 10 repetitions of each exercise and complete as many rounds as possible within the specified time. Between blocks, there will be a prescribed active rest period lasting three minutes, during which patients will walk on the treadmill at an intensity of 60-70% of peak heart rate. The last part of the training is a cool-down (5 minutes treadmill walking at an intensity of 50-60% of peak heart rate).
Treatment groups
57 Participants
are divided into 3 treatment groupsGroup A: Experimental HIIT.Experimental treatment 1 intervention
Group B: Experimental HIFT.Experimental treatment 1 intervention
Group C: No intervention: Control.No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Concentration of proteins in blood (proteome).
Venous blood samples are collected from the antecubital vein and kept at 4°C until preparation to avoid clotting and minimise protein degradation. Samples are centrifuged at 1500 g for 10 minutes at 4°C. Samples shall are stored at -80°C for subsequent analysis and only one freeze-thaw cycle shall be allowed. All samples shall are prepared within 1 hour of sample collection and show no signs of haemolysis. The protein concentrarion will be analyzed (μg/ml).
Time frame
0 weeks, 2 weeks, 13 weeks, 24 weeks.2
Oxidative stress status
Oxidative stress is measured through the analysis of plasma oxidative stress biomarkers concentrations in pg/ml.
Time frame
0 weeks, 2 weeks, 13 weeks, 24 weeks.3
Cardiac function: concentrations (pg/ml) of NT-proBNP (type B natriuretic peptide).
Measurement of cardiac dysfunction is analyzed through the presence of plasma markers of cardiac injury (NT-proBNP; pg/ml).
Time frame
0 weeks, 2 weeks, 13 weeks, 24 weeks.4
Maximal strength of upper and lower extremity muscles.
Maximal strength of upper and lower extremity muscles from one concentric repetition maximum (1RM) of half squat and bench press will be assessed (maximal strength). Measurements in weight lifted and the number of times. Maximum Repetition or 1RM is the maximum weight (kg) you can move in just one time.
Time frame
0 weeks, 2 weeks, 13 weeks, 24 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
European University Miguel de Cervantes
Lead sponsor
Hospital Clínico Universitario de Valladolid
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: