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CompletedNCT01418027Updated Sep 1, 2014

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

A Phase 3 interventional study of Intensive exercise and Conventional exercise in Non-alcoholic Fatty Liver Disease (NAFLD), sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-09-01.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Non-alcoholic Fatty Liver Disease (NAFLD)

Keywords

  • NAFLD
  • exercise
  • hepatic triglycerides
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 220 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    Intensive exercise

    The subjects receive an intensive exercise for 6 months and a subsequent conventional exercise for another 6 months.

    Other: Intensive exercise

  • 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

Interventions

  • OtherIntensive 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.

  • OtherConventional 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.

06

What researchers measure

Primary outcomes

  1. Change of intrahepatic triglyceride contents

    Time frame: 12 months

Secondary outcomes

  1. Change of body weight

    Time frame: 12 months

  2. Change of waist circumference

    Time frame: 12 months

  3. Change of body fat

    Time frame: 12 months

  4. Change of abdominal fat

    Time frame: 12 montshs

  5. Change of carotid intima-media thickness

    Time frame: 12 months

  6. Change of cardiovascular risk factors (Blood pressure, lipids, glucose)

    Time frame: 12 months

  7. Change of insulin resistance

    Time frame: 12 months

07

Study locations

1 site
  • The First Hospital Affiliated to Xiamen University
    Xiamen, China
08

References and documents

Publications

  • 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. PubMed 27379904 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01418027
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Xiao-Ying Li (Professor, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Aug 16, 2011
Start date
Aug 2011
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Sep 1, 2014

Study contacts

Xiaoying Li, MD,PhD
principal investigator · Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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