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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741957
• Other study ID #: HKU-NFF
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: Parco M. Siu, PhD
• Phone: 2831 5262
• Email: pmsiu[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
Hong Kong	LKS Faculty of Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)