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

NCT ID: NCT01418027

Last Updated: 2014-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease (NAFLD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive exercise

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

Group Type EXPERIMENTAL

Intensive exercise

Intervention Type OTHER

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.

Lifestyle counseling

Subjects receive a general lifestyle counseling for 12 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Regular exercise

Subjects receive conventional exercise for 12 months

Group Type EXPERIMENTAL

Conventional exercise

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xiao-Ying Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoying Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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The First Hospital Affiliated to Xiamen University

Xiamen, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 27379904 (View on PubMed)

Other Identifiers

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CCEMD011

Identifier Type: -

Identifier Source: org_study_id

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