Exercise and Dietary Lifestyle Intervention on Reducing Atrial Fibrillation Burden, Cardiac and Body Fat Mass.

University of Eastern Finland158 enrolled

Overview

Atrial fibrillation (AF) is the most common cardiac arrhythmia and is strongly associated with obesity and excess body fat. Lifestyle interventions, including exercise and dietary modification, may reduce AF burden, but long-term randomized controlled trial evidence with objective AF burden assessment and advanced cardiac imaging is limited. The MOVE-AF trial is a randomized controlled trial designed to evaluate whether a 12-month tailored exercise and dietary lifestyle intervention, compared with usual care, reduces atrial fibrillation burden and symptom severity and decreases cardiac and total body fat mass in overweight and obese adults with paroxysmal or persistent AF.

Obesity is a major modifiable risk factor for atrial fibrillation and contributes to AF pathophysiology through systemic inflammation, autonomic imbalance, and adverse cardiac remodeling, including increased epicardial and atrial fat. Although exercise and weight reduction have been shown to improve AF-related outcomes, robust long-term randomized evidence integrating exercise, dietary intervention, objective AF burden monitoring, and cardiac magnetic resonance imaging is lacking. MOVE-AF is a parallel-group, open-label randomized controlled trial enrolling 158 overweight or obese adults with symptomatic paroxysmal or persistent AF. Participants will be randomized 1:1 to receive either a tailored exercise and dietary lifestyle intervention plus usual care or usual care alone. The intervention consists of individualized guideline-based aerobic and resistance exercise combined with dietary counseling aimed at reducing body fat mass. Main outcomes include AF burden assessed using continuous ambulatory rhythm monitoring, AF symptom severity assessed using validated questionnaires, and cardiac and total body fat mass assessed by cardiac MRI and body composition analysis. Secondary outcomes include cardiorespiratory fitness, muscle strength, cardiac autonomic nervous system function, cardiac remodeling, healthcare utilization, cost-effectiveness, and genetic risk modification of intervention effects. The study is conducted in accordance with the Declaration of Helsinki and applicable regulatory requirements. All participants will provide written informed consent before enrollment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

Tailored Exercise and Dietary Lifestyle ProgramBEHAVIORAL

A 12-month tailored lifestyle program combining individualized aerobic exercise, muscle strength training, and dietary counseling. The program includes home-based aerobic training 2-5 times per week, muscle strength training, group-based dietary intervention sessions, and motivational support. The intervention is added to standard clinical care for atrial fibrillation.

Usual Clinical CareOTHER

Participants receive standard clinical care for atrial fibrillation according to the guideline-based routine practice at participating hospitals. No structured exercise or dietary lifestyle intervention is provided.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-75 years * Body mass index (BMI) ≥27 kg/m² * Documented atrial fibrillation (paroxysmal or persistent) * Ability to participate in exercise training and follow study procedures * Access to a smartphone or device enabling rhythm monitoring * Provides written informed consent Exclusion Criteria: * Permanent atrial fibrillation * Unstable angina pectoris or acute coronary syndrome within the past 3 months * Participation in other lifestyle or drug weight reduction trials * Significant left ventricular dysfunction (ejection fraction \<30%) * Severe valvular heart disease or planned cardiac surgery * Severe heart failure (NYHA class IV) or severe angina (CCS class IV) * Unstable coronary artery disease or recent myocardial infarction * Severe pulmonary disease limiting exercise capacity * Active malignancy * Autoimmune or systemic inflammatory diseases * Severe renal or hepatic failure * Memory disease or significant cognitive impairment * Unstable psychiatric condition * Recent joint or back surgery within the past 6 months * Continuing back or joint pain symptoms and inability to take part in individualized exercise training * Contraindications to exercise testing or training, including cardiac symptoms or cardiovascular symptoms, making exercise unsafe * Pregnancy or breastfeeding * Participation in another interventional study * Any condition judged by investigators to make participation unsafe or infeasible

Locations (4)

Hospital Nova of Central Finland

Jyväskylä, Central Finland, Finland

RECRUITING

University of Eastern Finland

Kuopio, Eastern Finland, Finland

NOT_YET_RECRUITING

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

NOT_YET_RECRUITING

Tampere University Hospital

Tampere, Finland

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Atrial Fibrillation Burden

Total atrial fibrillation burden measured by continuous rhythm monitoring over the intervention period. Unit of Measure: Percentage of time in atrial fibrillation (%)

Time frame: 12 months

Secondary Outcomes

Cardiac Fat Mass

Epicardial and pericardial fat volume measured by cardiac MRI. Unit of Measure: Milliliters (ml).

Time frame: 12 months

AF Symptom Severity

Symptom severity assessed using the Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT). Unit of Measure: Score on a 0-100 scale. Interpretation: Higher scores indicate better AF-related quality of life (i.e., fewer or less severe symptoms).

Time frame: 12 months

Body Fat Mass

Total body fat mass assessed using a body composition analyzer. Unit of Measure: Kilograms (kg)

Time frame: 12 months

Six-Minute Walk Test (6MWT)

Functional exercise capacity assessed using the Six-Minute Walking Test (6MWT). Unit of Measure: Meters walked in 6 minutes. Interpretation: Higher values indicate better functional capacity.

Time frame: 12 months

AF-Related Quality of Life (AFEQT Overall Score)

AF-related quality of life assessed using the Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT). Unit of Measure: Score (0-100). Interpretation: Higher scores indicate a better quality of life.

Time frame: 12 months

Cost-effectiveness analysis

Healthcare costs determined using patients' social security ID numbers to track specialized healthcare visits, imaging examinations, treatment days, AF treatments, and external service usage. Unit of Measure: Euro (€)

Time frame: 36 months

Left Atrial Volume

Left atrial volume measured by echocardiography. Unit of Measure: Milliliters (ml)

Time frame: 12 months

Cardiac autonomic nervous system function

Heart rate variability assessed using a standardized protocol with 2 minutes sitting followed by 3 minutes of standing. Unit of Measure: HRV parameters (ms)

Time frame: 12 months

Peak Oxygen Uptake (VO₂peak)

Cardiorespiratory fitness assessed using cardiopulmonary exercise testing (CPET). Unit of Measure: VO₂peak (ml/kg/min) Interpretation: Higher values indicate better cardiorespiratory fitness.

Time frame: 12 months

Left Atrial Volume Index

Left atrial volume indexed to body surface area by echocardiography. Unit of Measure: ml/m²

Time frame: 12 months

Left Atrial Strain

Left atrial strain measured by speckle-tracking echocardiography. Unit of Measure: Percentage (%)

Time frame: 12 months

Left Ventricular Ejection Fraction

Left ventricular systolic function assessed by echocardiography. Unit of Measure: Percentage (%)

Time frame: 12 months

E/e' Ratio

Left ventricular diastolic function assessed using transmitral inflow and tissue Doppler imaging. Unit of Measure: Unitless ratio

Time frame: 12 months

Exercise and Dietary Lifestyle Intervention on Reducing Atrial Fibrillation Burden, Cardiac and Body Fat Mass.

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts