Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kuopio University Hospital | OTHER |
| Tampere University Hospital | OTHER |
| UKK Institute | OTHER |
| Hospital Nova, Central Finland |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Clinical Care | Other | Participants receive standard clinical care for atrial fibrillation without any structured exercise or dietary lifestyle intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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). |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jari Laukkanen, MD, PhD | Contact | +358505053013 | jariantero.laukkanen@uef.fi | |
| Merja Perhonen, MD, PhD | Contact | +358406624456 | merja.perhonen@hyvaks.fi |
| Name | Affiliation | Role |
|---|---|---|
| Jari Laukkanen, MD, PhD | University of Eastern Finland | Principal Investigator |
| Jari Laukkanen, MD, PhD | University of Eastern Finland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nova of Central Finland | Recruiting | Jyväskylä | Central Finland | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36254719 | Result | 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. |
| Label | URL |
|---|---|
| MOVE-AF study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
| 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 |
| 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 |
| University of Eastern Finland | Not yet recruiting | Kuopio | Eastern Finland | Finland |
|
| Kuopio University Hospital | Not yet recruiting | Kuopio | Northern Savonia | Finland |
|
| Tampere University Hospital | Not yet recruiting | Tampere | Finland |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
Not provided
Not provided