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

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease; Obesity
• Interventions: Behavioral: Once-a-week Exercise; Other: Usual Care Control; Behavioral: Thrice-a-week Exercise

• Registration Number: NCT05741957
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-23
• Study Start: 2023-03-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Cantonese, Mandarin, or English speaking Chinese;
2. Aged 18-69;
3. Male or female;
4. Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23;
5. With NAFLD (defined as >5% intrahepatic triglycerides assessed by 1H-MRS);
6. Willing to participate in exercise training to improve NAFLD.

Exclusion Criteria

1. Regular exercise training (>3 sessions of >60 min of moderate-intensity exercise training weekly) in the past 6 months;
2. Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD;
3. Somatic conditions that limit exercise participation (e.g., limb loss);
4. Impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases);
5. Daily smoking habit;
6. Excess alcohol consumption (daily ≥20 g of alcohol for men and ≥10 g for women) in the past 1 year;
7. Consumption of certain drugs (e.g., tamoxifen and estrogen) known to be secondary causes of steatosis;
8. 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);
9. Physical changes that considerably affect body composition and weight (e.g., anorexia nervosa, bulimia nervosa, prolonged gastrointestinal and digestive disorders) during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Once-a-week Exercise	Once-a-week Exercise	Once-a-week vigorous-intensity exercise for 4 months.
Usual Care Control	Usual Care Control	Bi-weekly health education for 4 months.
Thrice-a-week Exercise	Thrice-a-week Exercise	Thrice-a-week vigorous-intensity exercise for 4 months.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LKS Faculty of Medicine; 🇭🇰 Hong Kong, Hong Kong