Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 6:08 PM
Study NCT ID:
NCT05741957
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2023-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Liver Fat', 'timeFrame': 'Baseline and 4 months (post-intervention)', 'description': 'Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel.'}], 'secondaryOutcomes': [{'measure': 'Change in Liver Fat', 'timeFrame': 'Baseline and 10 months (follow-up)', 'description': 'Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel.'}, {'measure': 'Change in Abdominal Visceral Fat', 'timeFrame': 'Baseline, 4 months (post-intervention), and 10 months (follow-up)', 'description': 'Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI).'}, {'measure': 'Change in Body Fat', 'timeFrame': 'Baseline, 4 months (post-intervention), and 10 months (follow-up)', 'description': 'Total body fat mass will be assessed using dual-energy x-ray absorptiometry (DXA).'}, {'measure': 'Change in Body Mass Index', 'timeFrame': 'Baseline, 4 months (post-intervention), and 10 months (follow-up)', 'description': 'Weight and height will be assessed using a calibrated electronic digital weighing scale and a stadiometer, respectively.'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline, 4 months (post-intervention), and 10 months (follow-up)', 'description': 'Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1 cm on bare skin.'}, {'measure': 'Change in Maximal Oxygen Consumption', 'timeFrame': 'Baseline, 4 months (post-intervention), and 10 months (follow-up)', 'description': 'Maximal oxygen consumption will be assessed using the modified Bruce protocol.'}, {'measure': 'Change in Physical Component Summary Score of the 12-Item Short-Form Health Survey', 'timeFrame': 'Baseline, 4 months (post-intervention), and 10 months (follow-up)', '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.'}, {'measure': 'Change in Mental Component Summary Score of the 12-Item Short-Form Health Survey', 'timeFrame': 'Baseline, 4 months (post-intervention), and 10 months (follow-up)', '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.'}, {'measure': 'Number of Adverse Events', 'timeFrame': 'Baseline, 4 months (post-intervention), and 10 months (follow-up)', 'description': 'Adverse events related or unrelated to the intervention will be assessed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Alcoholic Fatty Liver Disease', 'Overweight', 'Central Obesity', 'Obesity', 'Adults', 'Aerobic Exercise', 'Exercise Frequency'], 'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Obesity']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cantonese, Mandarin, or English speaking Chinese;\n2. Aged 18-69;\n3. Male or female;\n4. Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23;\n5. With NAFLD (defined as \\>5% intrahepatic triglycerides assessed by 1H-MRS);\n6. Willing to participate in exercise training to improve NAFLD.\n\nExclusion Criteria:\n\n1. Regular exercise training (\\>3 sessions of \\>60 min of moderate-intensity exercise training weekly) in the past 6 months;\n2. Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD;\n3. Somatic conditions that limit exercise participation (e.g., limb loss);\n4. Impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases);\n5. Daily smoking habit;\n6. Excess alcohol consumption (daily ≥20 g of alcohol for men and ≥10 g for women) in the past 1 year;\n7. Consumption of certain drugs (e.g., tamoxifen and estrogen) known to be secondary causes of steatosis;\n8. 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);\n9. Physical changes that considerably affect body composition and weight (e.g., anorexia nervosa, bulimia nervosa, prolonged gastrointestinal and digestive disorders) during the study period.'}, 'identificationModule': {'nctId': 'NCT05741957', 'briefTitle': 'Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HKU-NFF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Once-a-week Exercise', 'description': 'Once-a-week vigorous-intensity exercise for 4 months.', 'interventionNames': ['Behavioral: Once-a-week Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Thrice-a-week Exercise', 'description': 'Thrice-a-week vigorous-intensity exercise for 4 months.', 'interventionNames': ['Behavioral: Thrice-a-week Exercise']}, {'type': 'OTHER', 'label': 'Usual Care Control', 'description': 'Bi-weekly health education for 4 months.', 'interventionNames': ['Other: Usual Care Control']}], 'interventions': [{'name': 'Once-a-week Exercise', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Once-a-week Exercise']}, {'name': 'Thrice-a-week Exercise', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Thrice-a-week Exercise']}, {'name': 'Usual Care Control', 'type': 'OTHER', '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.', 'armGroupLabels': ['Usual Care Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Parco M. Siu, PhD', 'role': 'CONTACT', 'email': 'pmsiu@hku.hk', 'phone': '2831 5262'}, {'name': 'Joshua Bernal, BSc', 'role': 'CONTACT', 'email': 'jdkb9701@connect.hku.hk', 'phone': '2831 5258'}, {'name': 'Parco M. Siu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joshua Bernal, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teryn Ng, BENS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'LKS Faculty of Medicine', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Parco M. Siu, PhD', 'role': 'CONTACT', 'email': 'pmsiu@hku.hk', 'phone': '2831 5262'}], 'overallOfficials': [{'name': 'Parco M. Siu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LKS Faculty of Medicine, The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months and ending 3 years following the publication of the article.', 'ipdSharing': 'YES', '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Division Head', 'investigatorFullName': 'Parco M. Siu, PhD', 'investigatorAffiliation': 'The University of Hong Kong'}}}}