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NCT Number: NCT05741957

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKS Faculty of Medicine

Hong Kong

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Once-a-week Exercise

Behavioral

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.

Thrice-a-week Exercise

Behavioral

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.

Usual Care Control

Other

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.

Primary outcomes

  1. Change in Liver Fat

    Time frame: 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 outcomes

  1. Change in Liver Fat

    Time frame: Baseline and 10 months (follow-up)

    Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel.

  2. Change in Abdominal Visceral Fat

    Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)

    Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI).

  3. Change in Body Fat

    Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)

    Total body fat mass will be assessed using dual-energy x-ray absorptiometry (DXA).

  4. Change in Body Mass Index

    Time frame: 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.

  5. Change in Waist Circumference

    Time frame: 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.

  6. Change in Maximal Oxygen Consumption

    Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)

    Maximal oxygen consumption will be assessed using the modified Bruce protocol.

  7. Change in Physical Component Summary Score of the 12-Item Short-Form Health Survey

    Time frame: 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.

  8. Change in Mental Component Summary Score of the 12-Item Short-Form Health Survey

    Time frame: 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.

  9. Number of Adverse Events

    Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)

    Adverse events related or unrelated to the intervention will be assessed.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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