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

August 28, 2014 updated by: Xiao-Ying Li, Shanghai Jiao Tong University School of Medicine

Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Xiamen, China
        • The First Hospital Affiliated to Xiamen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Subjects with NAFLD determined by MRS ;
  2. Age 40-65 years old;
  3. Waist circumference> 90cm for men and > 85cm for women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of intrahepatic triglyceride contents
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of body weight
Time Frame: 12 months
12 months
Change of waist circumference
Time Frame: 12 months
12 months
Change of body fat
Time Frame: 12 months
12 months
Change of abdominal fat
Time Frame: 12 montshs
12 montshs
Change of carotid intima-media thickness
Time Frame: 12 months
12 months
Change of cardiovascular risk factors (Blood pressure, lipids, glucose)
Time Frame: 12 months
12 months
Change of insulin resistance
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Xiaoying Li, MD,PhD, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEMD011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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