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

Non-alcoholic Fatty Liver Disease (NAFLD) Clinical Trial

Official title:

Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418027
• Other study ID #: CCEMD011
• Status: Completed
• Phase: Phase 3
• First received: August 15, 2011
• Last updated: August 28, 2014
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

1. Subjects with NAFLD determined by MRS ;

2. Age 40-65 years old;

3. Waist circumference> 90cm for men and > 85cm for women.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The First Hospital Affiliated to Xiamen University	Xiamen

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of intrahepatic triglyceride contents		12 months	No
Secondary	Change of body weight		12 months	No
Secondary	Change of waist circumference		12 months	No
Secondary	Change of body fat		12 months	No
Secondary	Change of abdominal fat		12 montshs	No
Secondary	Change of carotid intima-media thickness		12 months	No
Secondary	Change of cardiovascular risk factors (Blood pressure, lipids, glucose)		12 months	No
Secondary	Change of insulin resistance		12 months	No