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Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiao-Ying Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01418027
First received: August 15, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Non-alcoholic Fatty Liver Disease (NAFLD)
Other: Intensive exercise
Other: Conventional exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Change of intrahepatic triglyceride contents [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of body weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change of waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change of body fat [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change of abdominal fat [ Time Frame: 12 montshs ] [ Designated as safety issue: No ]
  • Change of carotid intima-media thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change of cardiovascular risk factors (Blood pressure, lipids, glucose) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change of insulin resistance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: August 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive exercise
The subjects receive an intensive exercise for 6 months and a subsequent conventional exercise for another 6 months.
Other: Intensive exercise
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.
No Intervention: Lifestyle counseling
Subjects receive a general lifestyle counseling for 12 months
Experimental: Regular exercise
Subjects receive conventional exercise for 12 months
Other: Conventional exercise
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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Subjects with NAFLD determined by MRS ;
  2. Age 40-65 years old;
  3. Waist circumference> 90cm for men and > 85cm for women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418027

Locations
China
The First Hospital Affiliated to Xiamen University
Xiamen, China
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Xiaoying Li, MD,PhD Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Xiao-Ying Li, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01418027     History of Changes
Other Study ID Numbers: CCEMD011
Study First Received: August 15, 2011
Last Updated: August 28, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
NAFLD
exercise
hepatic triglycerides

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on November 27, 2014