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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 3

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Treatments: Other: Conventional exercise; Other: Intensive exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01418027

CCEMD011

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

Intensive exercise

Experimental group

Description:

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

Treatment:

Other: Intensive exercise

Lifestyle counseling

No Intervention group

Description:

Subjects receive a general lifestyle counseling for 12 months

Regular exercise

Experimental group

Description:

Subjects receive conventional exercise for 12 months

Treatment:

Other: Conventional exercise