Clinical trial NCT06607510: Exercise Effects on Atrial Fibrillation
Official title: Exercise in Patients With Atrial Fibrillation: Effect of Different Types of Exercise on the Burden of the Pathology, on the Biochemical Profile, and on the Functional Capacity of the Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: HIFT
HIIT
Intervallic training
Arrhythmia
Lead sponsor: European University Miguel de Cervantes
Sponsor class: OTHER
Collaborators: name: Hospital Clínico Universitario de Valladolid
First posted: 2024-09-23
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective single-center randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* Paroxysmal or persistent atrial fibrillation.
* Age between 18 and 80 years.
* Sedentary lifestyle.
* Signed informed consent.

Exclusion Criteria:

* Permanent atrial fibrillation.
* Moderate to severe left ventricular dysfunction.
* Moderate to severe left valvulopathy.
* Severe pulmonary hypertension.
* Ischemic heart disease with incomplete revascularization.
* Arrhythmogenic cardiomyopathy.

Primary outcomes:
measure: Concentration of proteins in blood (proteome).
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Oxidative stress status
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Cardiac function: concentrations (pg/ml) of NT-proBNP (type B natriuretic peptide).
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Maximal strength of upper and lower extremity muscles.
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Functional variables: power strength by bar displacement
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Functional variables: power strength by propulsive velocity
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Functional variables: power strength
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Functional variables: Handgrip strength.
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Functional variables: Assessment of cardiorespiratory capacity.
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Functional variables: Assessment of functional capacity (6MWT).
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Functional variables: Levels of physical activity
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Clinical variables: Short Form-36 Health Survey (SF-36).
timeFrame: 0 weeks, 13 weeks, 24 weeks.
measure: Clinical variables: Atrial fibrillation burden.
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Clinical variables: Atrial fibrillation burden (subjective measurement).
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Clinical variables: Arterial stiffness.
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Clinical variables: Heart rate variability.
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
measure: Clinical variables: Vascular dysfunction.
timeFrame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Universidad Europea Miguel de Cervantes
Study officials:
References: