Back to resultsOptimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Once-a-week Exercise
Thrice-a-week Exercise
Usual Care Control
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Non-Alcoholic Fatty Liver Disease, Overweight, Central Obesity, Obesity, Adults, Aerobic Exercise, Exercise Frequency
Eligibility Criteria
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.
Sites / Locations
- LKS Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Once-a-week Exercise
Thrice-a-week Exercise
Usual Care Control
Arm Description
Once-a-week vigorous-intensity exercise for 4 months.
Thrice-a-week vigorous-intensity exercise for 4 months.
Bi-weekly health education for 4 months.
Outcomes
Primary Outcome Measures
Change in Liver Fat
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
Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel.
Change in Abdominal Visceral Fat
Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI).
Change in Body Fat
Total body fat mass will be assessed using dual-energy x-ray absorptiometry (DXA).
Change in Body Mass Index
Weight and height will be assessed using a calibrated electronic digital weighing scale and a stadiometer, respectively.
Change in Waist Circumference
Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1 cm on bare skin.
Change in Maximal Oxygen Consumption
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
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
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
Adverse events related or unrelated to the intervention will be assessed.
Full Information
NCT ID
NCT05741957
First Posted
February 13, 2023
Last Updated
May 9, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05741957
Brief Title
Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Obesity
Keywords
Non-Alcoholic Fatty Liver Disease, Overweight, Central Obesity, Obesity, Adults, Aerobic Exercise, Exercise Frequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Once-a-week Exercise
Arm Type
Experimental
Arm Description
Once-a-week vigorous-intensity exercise for 4 months.
Arm Title
Thrice-a-week Exercise
Arm Type
Experimental
Arm Description
Thrice-a-week vigorous-intensity exercise for 4 months.
Arm Title
Usual Care Control
Arm Type
Other
Arm Description
Bi-weekly health education for 4 months.
Intervention Type
Behavioral
Intervention Name(s)
Once-a-week Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Thrice-a-week Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care Control
Intervention Description
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 Outcome Measure Information:
Title
Change in Liver Fat
Description
Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel.
Time Frame
Baseline and 4 months (post-intervention)
Secondary Outcome Measure Information:
Title
Change in Liver Fat
Description
Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel.
Time Frame
Baseline and 10 months (follow-up)
Title
Change in Abdominal Visceral Fat
Description
Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI).
Time Frame
Baseline, 4 months (post-intervention), and 10 months (follow-up)
Title
Change in Body Fat
Description
Total body fat mass will be assessed using dual-energy x-ray absorptiometry (DXA).
Time Frame
Baseline, 4 months (post-intervention), and 10 months (follow-up)
Title
Change in Body Mass Index
Description
Weight and height will be assessed using a calibrated electronic digital weighing scale and a stadiometer, respectively.
Time Frame
Baseline, 4 months (post-intervention), and 10 months (follow-up)
Title
Change in Waist Circumference
Description
Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1 cm on bare skin.
Time Frame
Baseline, 4 months (post-intervention), and 10 months (follow-up)
Title
Change in Maximal Oxygen Consumption
Description
Maximal oxygen consumption will be assessed using the modified Bruce protocol.
Time Frame
Baseline, 4 months (post-intervention), and 10 months (follow-up)
Title
Change in Physical Component Summary Score of the 12-Item Short-Form Health Survey
Description
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.
Time Frame
Baseline, 4 months (post-intervention), and 10 months (follow-up)
Title
Change in Mental Component Summary Score of the 12-Item Short-Form Health Survey
Description
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.
Time Frame
Baseline, 4 months (post-intervention), and 10 months (follow-up)
Title
Number of Adverse Events
Description
Adverse events related or unrelated to the intervention will be assessed.
Time Frame
Baseline, 4 months (post-intervention), and 10 months (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parco M. Siu, PhD
Phone
2831 5262
Email
pmsiu@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parco M. Siu, PhD
Organizational Affiliation
LKS Faculty of Medicine, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKS Faculty of Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parco M. Siu, PhD
Phone
2831 5262
Email
pmsiu@hku.hk
First Name & Middle Initial & Last Name & Degree
Joshua Bernal, BSc
Phone
2831 5258
Email
jdkb9701@connect.hku.hk
First Name & Middle Initial & Last Name & Degree
Parco M. Siu, PhD
First Name & Middle Initial & Last Name & Degree
Joshua Bernal, BSc
First Name & Middle Initial & Last Name & Degree
Teryn Ng, BENS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.
IPD Sharing Time Frame
Beginning 3 months and ending 3 years following the publication of the article.
IPD Sharing Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.
Learn more about this trial
Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease
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