Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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This study aims to examine the comparative effectiveness of different exercise frequencies (once-a-week vs. thrice-a-week) for reducing liver fat in centrally obese adults with non-alcoholic fatty liver disease (NAFLD), with weekly exercise volumes aligned with the World Health Organization's physical activity recommendations.

Detailed Description
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This study is a three-arm randomized controlled trial. Participants will be randomly allocated to the once-a-week exercise group, thrice-a-week exercise group, or usual care control group. The exercise intervention groups will receive once-a-week or thrice-a-week exercise (with matched weekly exercise volumes). The usual care control group will receive general health education. All interventions will last for 4 months. Outcome measures will be examined at baseline, 4 months (post-intervention), and 10 months (6-month follow-up).

Official Title
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Examining the Optimal Exercise Frequency for Alleviating Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease (NAFLD): A Comparative Randomized Controlled Trial

Conditions
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Non-Alcoholic Fatty Liver Disease, Obesity

Intervention / Treatment
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* Behavioral: Once-a-week Exercise
* Behavioral: Thrice-a-week Exercise
* Other: Usual Care Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cantonese, Mandarin, or English speaking Chinese; Aged 18-69; Male or female; Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23; With NAFLD (defined as >5% intrahepatic triglycerides assessed by 1H-MRS); Willing to participate in exercise training to improve NAFLD. Exclusion Criteria: Regular exercise training (>3 sessions of >60 min of moderate-intensity exercise training weekly) in the past 6 months; Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD; Somatic conditions that limit exercise participation (e.g., limb loss); Impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases); Daily smoking habit; Excess alcohol consumption (daily ≥20 g of alcohol for men and ≥10 g for women) in the past 1 year; Consumption of certain drugs (e.g., tamoxifen and estrogen) known to be secondary causes of steatosis; Surgery, therapy, or medication for obesity or weight loss in the past 6 months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, or dietitian-prescribed dietary program); Physical changes that considerably affect body composition and weight (e.g., anorexia nervosa, bulimia nervosa, prolonged gastrointestinal and digestive disorders) during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once-a-week Exercise<br>Once-a-week vigorous-intensity exercise for 4 months. | Behavioral: Once-a-week Exercise<br>* Participants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve one session weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 75 min. Participants will exercise with an exercising heart rate at 6-7 metabolic equivalents (METs). Health information provided to the usual care control group will be made available to the participants in this group.<br>|
| Experimental: Thrice-a-week Exercise<br>Thrice-a-week vigorous-intensity exercise for 4 months. | Behavioral: Thrice-a-week Exercise<br>* Participants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve three sessions weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 25 min. Participants will exercise with an exercising heart rate at 6-7 METs. Health information provided to the usual care control group will be made available to the participants in this group.<br>|
| Other: Usual Care Control<br>Bi-weekly health education for 4 months. | Other: Usual Care Control<br>* Participants in this group will receive health education delivered by research personnel. This program will consist of eight two-hour bi-weekly sessions covering major health issues relating to general health and NAFLD, such as non-communicable diseases, infectious diseases, and a healthy lifestyle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liver Fat | Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel. | Baseline and 4 months (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liver Fat | Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel. | Baseline and 10 months (follow-up) | 
| Change in Abdominal Visceral Fat | Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI). | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 
| Change in Body Fat | Total body fat mass will be assessed using dual-energy x-ray absorptiometry (DXA). | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 
| Change in Body Mass Index | Weight and height will be assessed using a calibrated electronic digital weighing scale and a stadiometer, respectively. | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 
| Change in Waist Circumference | Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1 cm on bare skin. | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 
| Change in Maximal Oxygen Consumption | Maximal oxygen consumption will be assessed using the modified Bruce protocol. | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 
| Change in Physical Component Summary Score of the 12-Item Short-Form Health Survey | Physical health-related quality of life will be assessed using the Physical Component Summary scale of the 12-Item Short-Form Health Survey (SF-12). Scores on the scale range from 0 to 100, with higher scores indicating better physical health-related quality of life. | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 
| Change in Mental Component Summary Score of the 12-Item Short-Form Health Survey | Mental health-related quality of life will be assessed using the Mental Component Summary scale of the 12-Item Short-Form Health Survey (SF-12). Scores on the scale range from 0 to 100, with higher scores indicating better mental health-related quality of life. | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 
| Number of Adverse Events | Adverse events related or unrelated to the intervention will be assessed. | Baseline, 4 months (post-intervention), and 10 months (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Alcoholic Fatty Liver Disease, Overweight, Central Obesity, Obesity, Adults, Aerobic Exercise, Exercise Frequency