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

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05741957

Collaborator

(none)

300

Enrollment

Location

Arms

46.5

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease Obesity	Behavioral: Once-a-week Exercise Behavioral: Thrice-a-week Exercise Other: Usual Care Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Once-a-week Exercise Once-a-week vigorous-intensity exercise for 4 months.	Behavioral: Once-a-week Exercise 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.
Experimental: Thrice-a-week Exercise Thrice-a-week vigorous-intensity exercise for 4 months.	Behavioral: Thrice-a-week Exercise 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.
Other: Usual Care Control Bi-weekly health education for 4 months.	Other: Usual Care Control 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.

Arm

Intervention/Treatment

Experimental: Once-a-week Exercise

Once-a-week vigorous-intensity exercise for 4 months.

Behavioral: Once-a-week Exercise

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.

Experimental: Thrice-a-week Exercise

Thrice-a-week vigorous-intensity exercise for 4 months.

Behavioral: Thrice-a-week Exercise

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.

Other: Usual Care Control

Bi-weekly health education for 4 months.

Other: Usual Care Control

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.

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 Maximal Oxygen Consumption [Baseline, 4 months (post-intervention), and 10 months (follow-up)]
Maximal oxygen consumption will be assessed using the modified Bruce protocol.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.