Back to resultsCombined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)
Primary Purpose
Non-alcoholic Fatty Liver Disease (NAFLD)
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Intensive exercise
Conventional exercise
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease (NAFLD) focused on measuring NAFLD, exercise, hepatic triglycerides
Eligibility Criteria
- Subjects with NAFLD determined by MRS ;
- Age 40-65 years old;
- Waist circumference> 90cm for men and > 85cm for women.
Sites / Locations
- The First Hospital Affiliated to Xiamen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
Intensive exercise
Lifestyle counseling
Regular exercise
Arm Description
The subjects receive an intensive exercise for 6 months and a subsequent conventional exercise for another 6 months.
Subjects receive a general lifestyle counseling for 12 months
Subjects receive conventional exercise for 12 months
Outcomes
Primary Outcome Measures
Change of intrahepatic triglyceride contents
Secondary Outcome Measures
Change of body weight
Change of waist circumference
Change of body fat
Change of abdominal fat
Change of carotid intima-media thickness
Change of cardiovascular risk factors (Blood pressure, lipids, glucose)
Change of insulin resistance
Full Information
NCT ID
NCT01418027
First Posted
August 15, 2011
Last Updated
August 28, 2014
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01418027
Brief Title
Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)
Official Title
Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In the present study we aim to compare the effect of intensive and conventional exercise interventions on NAFLD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease (NAFLD)
Keywords
NAFLD, exercise, hepatic triglycerides
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive exercise
Arm Type
Experimental
Arm Description
The subjects receive an intensive exercise for 6 months and a subsequent conventional exercise for another 6 months.
Arm Title
Lifestyle counseling
Arm Type
No Intervention
Arm Description
Subjects receive a general lifestyle counseling for 12 months
Arm Title
Regular exercise
Arm Type
Experimental
Arm Description
Subjects receive conventional exercise for 12 months
Intervention Type
Other
Intervention Name(s)
Intensive exercise
Intervention Description
Subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption for 30 minutes each day, five days a week, totally for 6 months.Subsequently, moderate physical activity(3.0-6.0 MET s) at 150 min/wk for 6 months.
Intervention Type
Other
Intervention Name(s)
Conventional exercise
Intervention Description
Subjects receive moderate physical activity(3.0-6.0 MET s) at 150 min/wk(30 min per day, five days a week) for 12 months.
Primary Outcome Measure Information:
Title
Change of intrahepatic triglyceride contents
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of body weight
Time Frame
12 months
Title
Change of waist circumference
Time Frame
12 months
Title
Change of body fat
Time Frame
12 months
Title
Change of abdominal fat
Time Frame
12 montshs
Title
Change of carotid intima-media thickness
Time Frame
12 months
Title
Change of cardiovascular risk factors (Blood pressure, lipids, glucose)
Time Frame
12 months
Title
Change of insulin resistance
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects with NAFLD determined by MRS ;
Age 40-65 years old;
Waist circumference> 90cm for men and > 85cm for women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoying Li, MD,PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital Affiliated to Xiamen University
City
Xiamen
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
27379904
Citation
Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.
Results Reference
derived
Learn more about this trial
Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)
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