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RecruitingNCT07430007

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
158 (estimated)
Sponsor
University of Eastern Finland · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALTailored Exercise and Dietary Lifestyle ProgramA 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.
OTHERUsual 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.

Timeline

Start date
2025-10-30
Primary completion
2027-12-31
Completion
2028-12-31
First posted
2026-02-24
Last updated
2026-02-24

Locations

4 sites across 1 country: Finland

Source: ClinicalTrials.gov record NCT07430007. Inclusion in this directory is not an endorsement.