Atrial Fibrillation (AF)MOVE-AFNCT07430007
Exercise and Dietary Lifestyle Intervention on Reducing Atrial Fibrillation Burden, Cardiac and Body Fat Mass.
A study testing Tailored Exercise and Dietary Lifestyle Program and Usual Clinical Care in people with Atrial Fibrillation (AF) and Obesity & Overweight, run by University of Eastern Finland at 4 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF), Obesity & Overweight
- What is being tested?
- Tailored Exercise and Dietary Lifestyle Program and Usual Clinical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 4 sitesFinland
- Study dates
- 30 Oct 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland4 sites, 4 recruiting
- Recruiting
Hospital Nova of Central Finland
Jyväskylä, Central Finland
Jari Laukkanen, MD, PhD, +358505053013, jariantero.laukkanen@uef.fi
Merja Perhonen, MD, PhD, +358406624456, merja.perhonen@hyvaks.fi
- Not yet recruiting
University of Eastern Finland
Kuopio, Eastern Finland
Jari Laukkanen, MD, PhD, +358505053013, jariantero.laukkanen@uef.fi
Merja Perhonen, MD, PhD, +358406624456, merja.perhonen@hyvaks.fi
- Not yet recruiting
Kuopio University Hospital
Kuopio, Northern Savonia
Marja Hedman, MD, PhD, +358505611768, marja.hedman@pshyvinvointialue.fi
Sudhir Kurl, MD, PhD, +358405468449, sudhir.kurl@uef.fi
- Not yet recruiting
Tampere University Hospital
Tampere
Jussi Hernesniemi, MD, PhD, +358417322932, jussi.hernesniemi@tuni.fi
Kerttu Toivo, MD, PhD, kerttu.toivo@ukkinstituutti.fi
About this study
Official 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
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.
- Conditions
- Atrial Fibrillation (AF), Obesity & Overweight
- Being tested
- Tailored Exercise and Dietary Lifestyle Program, Usual Clinical Care
- 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
- Medical subject headings
- Atrial Fibrillation, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Exercise and Dietary Lifestyle ProgramBehavioural
Also called 12-Month Tailored Exercise and Dietary Lifestyle Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 12-Month Tailored Exercise and Dietary Lifestyle Intervention | Experimental | 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. Receives: Behavioral: Tailored Exercise and Dietary Lifestyle Program |
| Usual Clinical Care | Other | Participants receive standard clinical care for atrial fibrillation without any structured exercise or dietary lifestyle intervention. Receives: Other: Usual Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 12 months
Secondary outcomes (13)
Cardiac Fat Mass
Epicardial and pericardial fat volume measured by cardiac MRI. Unit of Measure: Milliliters (ml).
Measured: 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).
Measured: 12 months
Body Fat Mass
Total body fat mass assessed using a body composition analyzer. Unit of Measure: Kilograms (kg)
Measured: 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.
Measured: 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.
Measured: 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 (€)
Measured: 36 months
Left Atrial Volume
Left atrial volume measured by echocardiography. Unit of Measure: Milliliters (ml)
Measured: 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)
Measured: 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.
Measured: 12 months
Left Atrial Volume Index
Left atrial volume indexed to body surface area by echocardiography. Unit of Measure: ml/m²
Measured: 12 months
Left Atrial Strain
Left atrial strain measured by speckle-tracking echocardiography. Unit of Measure: Percentage (%)
Measured: 12 months
Left Ventricular Ejection Fraction
Left ventricular systolic function assessed by echocardiography. Unit of Measure: Percentage (%)
Measured: 12 months
E/e' Ratio
Left ventricular diastolic function assessed using transmitral inflow and tissue Doppler imaging. Unit of Measure: Unitless ratio
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start30 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital, Tampere University Hospital, UKK Institute, Hospital Nova, Central Finland
- Responsible party
- Principal investigator, Jari Laukkanen, University of Eastern Finland
- Investigators
- Jari Laukkanen, MD, PhD, Principal investigator, University of Eastern FinlandJari Laukkanen, MD, PhD, Study director, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430007
- Sponsor's protocol ID
- 5U/2023
- Acronym
- MOVE-AF
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07430007
- Acronym / sponsor ID
- MOVE-AF / 5U/2023
- Conditions
- Atrial Fibrillation (AF), Obesity & Overweight
- Keywords
- Exercise training, Dietary intervention, Lifestyle intervention, Cardiac fatness, Cardiorespiratory fitness, Continuous rhythm monitoring, Photoplethysmography, Body composition analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Kuopio University Hospital, Tampere University Hospital, UKK Institute, Hospital Nova, Central Finland
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-Month Tailored Exercise and Dietary Lifestyle Intervention | Experimental | Behavioral: Tailored Exercise and Dietary Lifestyle ProgramParticipants receive standard clinical care for atrial fibrillation plus a 12-month tailored lifestyle program including individualized aerobic exercise, muscle strength training, and dietary counseling. |
| Usual Clinical Care | Other | Other: Usual Clinical CareParticipants receive standard clinical care for atrial fibrillation without any structured exercise or dietary lifestyle intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Exercise and Dietary Lifestyle ProgramAlso: 12-Month Tailored Exercise and Dietary Lifestyle InterventionA 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. | Behavioural | 12-Month Tailored Exercise and Dietary Lifestyle Intervention |
| Usual Clinical CareParticipants 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. | Other | Usual Clinical Care |
Primary outcome
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 (%)
13 secondary outcomes
Cardiac Fat Mass
Time frame: 12 months
AF Symptom Severity
Time frame: 12 months
Body Fat Mass
Time frame: 12 months
Six-Minute Walk Test (6MWT)
Time frame: 12 months
AF-Related Quality of Life (AFEQT Overall Score)
Time frame: 12 months
Cost-effectiveness analysis
Time frame: 36 months
Left Atrial Volume
Time frame: 12 months
Cardiac autonomic nervous system function
Time frame: 12 months
Peak Oxygen Uptake (VO₂peak)
Time frame: 12 months
Left Atrial Volume Index
Time frame: 12 months
Left Atrial Strain
Time frame: 12 months
Left Ventricular Ejection Fraction
Time frame: 12 months
E/e' Ratio
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Results publication: PubMed 36254719Alanko 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.
- MOVE-AF studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation (AF)
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jari Laukkanen, MD, PhD principal investigator
University of Eastern Finland
Jari Laukkanen, MD, PhD study director
University of Eastern Finland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Exercise and Dietary Lifestyle Program and Usual Clinical Care in people with Atrial Fibrillation (AF) and Obesity & Overweight, run by University of Eastern Finland at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jari Laukkanen, MD, PhD (+358505053013, jariantero.laukkanen@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation Burden (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.