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NCT Number: NCT07430007

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nova of Central Finland, Jyväskylä, Central Finland, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Exercise and Dietary Lifestyle Program

Behavioral

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.

Other names: 12-Month Tailored Exercise and Dietary Lifestyle Intervention

usual clinical care

Other

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.

Primary outcomes

  1. Atrial Fibrillation Burden

    Time frame: 12 months

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

Secondary outcomes

  1. Cardiac Fat Mass

    Time frame: 12 months

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

  2. AF Symptom Severity

    Time frame: 12 months

    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).

  3. Body Fat Mass

    Time frame: 12 months

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

  4. Six-Minute Walk Test (6MWT)

    Time frame: 12 months

    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.

  5. AF-Related Quality of Life (AFEQT Overall Score)

    Time frame: 12 months

    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.

  6. Cost-effectiveness analysis

    Time frame: 36 months

    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 (€)

  7. Left Atrial Volume

    Time frame: 12 months

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

  8. Cardiac autonomic nervous system function

    Time frame: 12 months

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

  9. Peak Oxygen Uptake (VO₂peak)

    Time frame: 12 months

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

  10. Left Atrial Volume Index

    Time frame: 12 months

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

  11. Left Atrial Strain

    Time frame: 12 months

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

  12. Left Ventricular Ejection Fraction

    Time frame: 12 months

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

  13. E/e' Ratio

    Time frame: 12 months

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

Other outcomes

  1. Natriuretic Peptides

    Time frame: 12 months

    Natriuretic propeptides, proBNP, Unit: pg/mL

  2. Dietary assessment

    Time frame: 12 months

    Dietary intake assessed using repeated 4-day food records. Unit of Measure: Nutrient intake per day (g/day, kcal/day).

  3. Physical Activity Level

    Time frame: 12 months

    Daily physical activity and sedentary time measured by accelerometry. Unit of Measure: Minutes per day (min/day).

  4. Inflammatory Markers

    Time frame: 12 months

    Inflammatory marker changes (C-reactive protein, CRP) Unit: mg/L

  5. Cytokines

    Time frame: 12 months

    Serum IL-6 concentration change Unit: pg/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Jari Laukkanen, MD, PhD

CONTACT

[email protected]

+358505053013

Merja Perhonen, MD, PhD

CONTACT

[email protected]

+358406624456

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Hospital Nova, Central Finland
  • Kuopio University Hospital
  • Tampere University Hospital
  • UKK Institute

Registry information

Official study title

Effect of a Tailored Exercise and Dietary Lifestyle Intervention on Reducing Atrial Fibrillation Burden, Cardiac and Body Fat Mass in Overweight and Obese Patients. The MOVE-AF Ran-domized Clinical Trial

Acronym: MOVE-AF

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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