ClinicalTrials.gg
RecruitingNCT07430007MOVE-AFUpdated Feb 24, 2026

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

An interventional study of Tailored Exercise and Dietary Lifestyle Program and Usual Clinical Care in Atrial Fibrillation (AF) and Obesity & Overweight, sponsored by University of Eastern Finland. Recruiting at 4 sites in Finland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by University of Eastern Finland · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation (AF)
  • Obesity & Overweight

Keywords

  • Exercise training
  • Dietary intervention
  • Lifestyle intervention
  • Cardiac fatness
  • Cardiorespiratory fitness
  • Continuous rhythm monitoring
  • Photoplethysmography
  • Body composition analysis
  • Cardiac MRI
  • Cost effectiveness
  • Body composition
  • Quality of life
  • AF burden
  • AF symptoms
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 158 is close to the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

University of Eastern Finland is the lead sponsor of 54 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-75 years
  • (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

Exclusion criteria

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 ( \<30%)
  • Severe valvular heart disease or planned cardiac surgery
  • Severe heart failure ( class IV) or severe angina (CCS class IV)
  • Unstable coronary artery disease or recent myocardial infarction
  • Severe pulmonary disease limiting exercise capacity
  • Active
  • 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
  • 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (estimated)

Study arms

  • 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

  • Other
    Usual Clinical Care

    Participants receive standard clinical care for atrial fibrillation without any structured exercise or dietary lifestyle intervention.

    Other: Usual Clinical Care

Interventions

  • BehavioralTailored 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.

    Also known as: 12-Month Tailored Exercise and Dietary Lifestyle Intervention

  • OtherUsual 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.

06

What researchers measure

Primary outcomes

  1. 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

  1. Cardiac Fat Mass

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

    Time frame: 12 months

  2. 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

  3. Body Fat Mass

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

    Time frame: 12 months

  4. 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

  5. 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

  6. 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

  7. Left Atrial Volume

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

    Time frame: 12 months

  8. 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

  9. 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

  10. Left Atrial Volume Index

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

    Time frame: 12 months

  11. Left Atrial Strain

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

    Time frame: 12 months

  12. Left Ventricular Ejection Fraction

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

    Time frame: 12 months

  13. E/e' Ratio

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

    Time frame: 12 months

Other outcomes

  1. Natriuretic Peptides

    Natriuretic propeptides, proBNP, Unit: pg/mL

    Time frame: 12 months

  2. Dietary assessment

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

    Time frame: 12 months

  3. Physical Activity Level

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

    Time frame: 12 months

  4. Inflammatory Markers

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

    Time frame: 12 months

  5. Cytokines

    Serum IL-6 concentration change Unit: pg/mL

    Time frame: 12 months

07

Study locations

1 of 4 sites recruiting
08

References and documents

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. PubMed 36254719 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07430007
Lead sponsor
University of Eastern Finland
Collaborators
Kuopio University Hospital, Tampere University Hospital, UKK Institute, Hospital Nova, Central Finland
Responsible party
Jari Laukkanen (Professor, cardiologist, University of Eastern Finland) — Principal investigator
First posted
Feb 24, 2026
Start date
Oct 30, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Feb 24, 2026

Study contacts

Jari Laukkanen, MD, PhD
Contact
jariantero.laukkanen@uef.fi
+358505053013
Merja Perhonen, MD, PhD
Contact
merja.perhonen@hyvaks.fi
+358406624456
Jari Laukkanen, MD, PhD
principal investigator · University of Eastern Finland
Jari Laukkanen, MD, PhD
study director · University of Eastern Finland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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