Actively Recruiting

Phase Not Applicable
Age: 18Years - 69Years
All Genders
NCT06124456

Vigorous- Versus Moderate-intensity Exercise to Reduce Liver Fat in Adults With Obesity and NAFLD

Led by The University of Hong Kong · Updated on 2024-07-09

330

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Non-alcoholic fatty liver disease (NAFLD) arising from obesity has become a global health concern. Although exercise is a cornerstone approach for managing NAFLD, detailed exercise prescription guidelines are unavailable. According to World Health Organization (WHO) recommendations, 1 minute of vigorous-intensity physical activity can achieve equivalent health benefits to 2 minutes of moderate-intensity physical activity. It is not known whether this relationship is applicable to exercise prescribed as an adjunct therapy in NAFLD treatment. The answer has public health implications because people living with NAFLD can potentially opt for safe higher-intensity exercise requiring less of a time commitment, whereas those in older age groups or with comorbidities, for whom vigorous exercise is unsuitable, can adopt a moderate-intensity regimen of longer duration to acquire equivalent therapeutic outcomes. Adults with obesity and NAFLD will be randomly allocated to a supervised vigorous- or moderate-intensity walking group or usual care control group. Each exercise group will receive a 16-week intervention comprising three walking sessions weekly, whereas the usual care group will receive general health education as the attention control. The per-session walking time will be 25 minutes for the vigorous group and 50 minutes for the moderate group, equating to the same weekly exercise volume and caloric expenditure for each group according to the WHO's minimum physical activity recommendation. Outcome measures, including liver fat, visceral and body fat, body anthropometry, intervention adherence, psychological measures, health-related quality of life, medication usage, adverse events, habitual physical activity, and diet, will be examined by assessors blinded to the group allocation at baseline, 16 weeks (post-intervention), and 42 weeks (26-week post-intervention follow-up). Data will be analyzed by generalized estimating equations and linear contrasts. The proposed study will provide evidence on the presumed equivalent benefits of vigorous- and moderate-intensity exercise, with a follow-up period allowing assessment of the efficacy, safety, adherence, and sustainability of each. The findings will inform practitioners of the role of exercise intensity in reducing liver fat and refine the exercise guidelines for NAFLD patients.

CONDITIONS

Official Title

Vigorous- Versus Moderate-intensity Exercise to Reduce Liver Fat in Adults With Obesity and NAFLD

Who Can Participate

Age: 18Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cantonese, Mandarin, or English-speaking Chinese
  • Aged between 18 and 69 years
  • Centrally obese with waist circumference of at least 90 cm for males or 80 cm for females
  • Body mass index (BMI) of 23 or higher
  • Diagnosed with non-alcoholic fatty liver disease (NAFLD) defined as over 5% intrahepatic triglycerides
  • Able to perform the prescribed exercise program
  • Both men and women are eligible
Not Eligible

You will not qualify if you...

  • Regular exercise training of more than 3 sessions per week, each over 60 minutes of moderate-intensity exercise, in the past 6 months
  • History of cardiovascular disease, chronic lung or kidney disease, heart failure, cancer, or liver disease other than NAFLD
  • Physical conditions limiting exercise participation such as limb loss
  • Impaired mobility due to chronic diseases like arthritis, neurological, musculoskeletal, or autoimmune diseases
  • Daily smoking habit
  • Excessive alcohol consumption defined as more than 20 g daily for men or more than 10 g daily for women in the past year
  • Use of drugs known to cause liver fat accumulation such as tamoxifen or estrogen
  • Surgery or therapy for morbid obesity in the past 6 months or during the study period, including gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, or dietitian-prescribed dietary programs

AI-Screening

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Trial Site Locations

Total: 1 location

1

LKS Faculty of Medicine

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

P

Parco M Siu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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