Exercise and Dietary Lifestyle Intervention on Reducing Atrial Fibrillation Burden, Cardiac and Body Fat Mass. (MOVE-AF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF); Obesity & Overweight
• Intervention / Treatment: Behavioral: Tailored Exercise and Dietary Lifestyle Program; Other: Usual Clinical Care

Detailed Description

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
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jari Laukkanen, MD, PhD; Phone Number: +358505053013; Email: jariantero.laukkanen@uef.fi
• Study Contact Backup: Name: Merja Perhonen, MD, PhD; Phone Number: +358406624456; Email: merja.perhonen@hyvaks.fi

Study Locations

• Finland
  • Tampere, Finland
    • Not yet recruiting
    • Tampere University Hospital
    • Contact: Jussi Hernesniemi, MD, PhD; Phone Number: +358417322932; Email: jussi.hernesniemi@tuni.fi
    • Contact: Kerttu Toivo, MD, PhD; Email: kerttu.toivo@ukkinstituutti.fi
  • Central Finland
    • Jyväskylä, Central Finland, Finland
      • Recruiting
      • Hospital Nova of Central Finland
      • Contact: Jari Laukkanen, MD, PhD; Phone Number: +358505053013; Email: jariantero.laukkanen@uef.fi
      • Contact: Merja Perhonen, MD, PhD; Phone Number: +358406624456; Email: merja.perhonen@hyvaks.fi
      • Sub-Investigator: Merja Perhonen, MD, PhD
  • Eastern Finland
    • Kuopio, Eastern Finland, Finland
      • Not yet recruiting
      • University of Eastern Finland
      • Contact: Jari Laukkanen, MD, PhD; Phone Number: +358505053013; Email: jariantero.laukkanen@uef.fi
      • Contact: Merja Perhonen, MD, PhD; Phone Number: +358406624456; Email: merja.perhonen@hyvaks.fi
      • Sub-Investigator: Sudhir Kurl, MD, PhD
  • Northern Savonia
    • Kuopio, Northern Savonia, Finland
      • Not yet recruiting
      • Kuopio University Hospital
      • Contact: Marja Hedman, MD, PhD; Phone Number: +358505611768; Email: marja.hedman@pshyvinvointialue.fi
      • Contact: Sudhir Kurl, MD, PhD; Phone Number: +358405468449; Email: sudhir.kurl@uef.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12-Month Tailored Exercise and Dietary Lifestyle Intervention; Participants receive standard clinical care for atrial fibrillation plus a 12-month tailored lifestyle program including individualized aerobic exercise, muscle strength training, and dietary counseling.	Behavioral: Tailored Exercise and Dietary Lifestyle Program; 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
Other: Usual Clinical Care; Participants receive standard clinical care for atrial fibrillation without any structured exercise or dietary lifestyle intervention.	Other: Usual Clinical Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Fat Mass	Epicardial and pericardial fat volume measured by cardiac MRI. Unit of Measure: Milliliters (ml).	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).	12 months
Body Fat Mass	Total body fat mass assessed using a body composition analyzer. Unit of Measure: Kilograms (kg)	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.	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.	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 (€)	36 months
Left Atrial Volume	Left atrial volume measured by echocardiography. Unit of Measure: Milliliters (ml)	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)	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.	12 months
Left Atrial Volume Index	Left atrial volume indexed to body surface area by echocardiography. Unit of Measure: ml/m²	12 months
Left Atrial Strain	Left atrial strain measured by speckle-tracking echocardiography. Unit of Measure: Percentage (%)	12 months
Left Ventricular Ejection Fraction	Left ventricular systolic function assessed by echocardiography. Unit of Measure: Percentage (%)	12 months
E/e' Ratio	Left ventricular diastolic function assessed using transmitral inflow and tissue Doppler imaging. Unit of Measure: Unitless ratio	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natriuretic Peptides	Natriuretic propeptides, proBNP, Unit: pg/mL	12 months
Dietary assessment	Dietary intake assessed using repeated 4-day food records. Unit of Measure: Nutrient intake per day (g/day, kcal/day).	12 months
Physical Activity Level	Daily physical activity and sedentary time measured by accelerometry. Unit of Measure: Minutes per day (min/day).	12 months
Inflammatory Markers	Inflammatory marker changes (C-reactive protein, CRP) Unit: mg/L	12 months
Cytokines	Serum IL-6 concentration change Unit: pg/mL	12 months

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Collaborators: Kuopio University Hospital; Tampere University Hospital; UKK Institute; Hospital Nova of Central Finland
• Investigators: Principal Investigator: Jari Laukkanen, MD, PhD, University of Eastern Finland; Study Director: Jari Laukkanen, MD, PhD, University of Eastern Finland

Publications and helpful links

General Publications

• Alanko L, Laukkanen JA, Rottensteiner M, Rasmus S, Kuha T, Valtonen M, Kujala UM. Sports and exercise medicine clinic in public hospital settings: a real-life concept and experiences of the treatment of the first 1151 patients. Postgrad Med. 2023 Apr;135(3):283-289. doi: 10.1080/00325481.2022.2135894. Epub 2022 Oct 18.

Helpful Links

• MOVE-AF study

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Body composition; Photoplethysmography; Exercise training; Cardiac MRI; Cardiorespiratory fitness; Lifestyle intervention; Cost effectiveness; Dietary intervention; AF burden; Body composition analysis; Cardiac fatness; Continuous rhythm monitoring; AF symptoms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Nutrition Disorders; Heart Diseases; Overnutrition; Body Weight; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Atrial Fibrillation
• Other Study ID Numbers: 5U/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No