Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 15, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 1, 2014
August 1, 2014
2.3 years
August 15, 2011
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of intrahepatic triglyceride contents
12 months
Secondary Outcomes (7)
Change of body weight
12 months
Change of waist circumference
12 months
Change of body fat
12 months
Change of abdominal fat
12 montshs
Change of carotid intima-media thickness
12 months
- +2 more secondary outcomes
Study Arms (3)
Intensive exercise
EXPERIMENTALThe subjects receive an intensive exercise for 6 months and a subsequent conventional exercise for another 6 months.
Lifestyle counseling
NO INTERVENTIONSubjects receive a general lifestyle counseling for 12 months
Regular exercise
EXPERIMENTALSubjects receive conventional exercise for 12 months
Interventions
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.
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.
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (1)
The First Hospital Affiliated to Xiamen University
Xiamen, China
Related Publications (1)
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.
PMID: 27379904DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoying Li, MD,PhD
Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 15, 2011
First Posted
August 16, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 1, 2014
Record last verified: 2014-08