Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)
This study is currently recruiting participants.
Verified June 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Xiao-Ying Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01418027
First received: August 15, 2011
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
The prevalence of NAFLD is 50-70% in obese. A decrease of calorie intake and increase of physical activity is recommended as an effective approach for NAFLD. The intensive physical activities are usually adopted. However,the effect of moderate physical activities on NAFLD has not been determined. We hypothesized that intensive induced conventional exercise would improve NAFLD better than the lifestyle counseling alone did.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-alcoholic Fatty Liver Disease (NAFLD) |
Other: Intensive exercise Other: Regular exercise |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease |
Resource links provided by NLM:
Further study details as provided by Shanghai Jiao Tong University School of Medicine:
Primary Outcome Measures:
- The change of intrahepatic triglyceride contents [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The change of rate of metabolic syndrome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intensive exercise
The subjects receive an intensive exercise for 6 months and a consequent regular exercise for another 6 months.
|
Other: Intensive exercise
Subects 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 h) 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 regular exercise for 12 months
|
Other: Regular exercise
Subjects receive moderate physical activity(3.0-6.0 MET h)per day for 12 months
|
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- Subjects with NAFLD determined by MRS ;
- Age 40-65 years old;
- Waist circumference＞ 90cm for men and ＞ 85cm for wemen.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418027
Contacts
| Contact: Ma Zhi-Min, MD | 86-592-2137558 | mazhimin01@sina.com |
| Contact: Zhang Hui-Jie, MD | 86-592-2137558 | huijiezhang2005@126.com |
Locations
| China, Fu Jian | |
| The First Hospital Affiliated to Xiamen University | Recruiting |
| Xiamen, Fu Jian, China | |
| Contact: Ma Zhi-Min, MD 86-592-2137558 mazhimin01@sina.com | |
| Contact: Zhang Hui-Jie, MD 86-592-2137558 huijiezhang2005@126.com | |
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
| Principal Investigator: | Xiaoying Li, MD,PhD | Shanghai Jiao Tong University School of Medicine |
More Information
No publications provided
| Responsible Party: | Xiao-Ying Li, Professor, Shanghai Jiao Tong University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01418027 History of Changes |
| Other Study ID Numbers: | CCEMD011 |
| Study First Received: | August 15, 2011 |
| Last Updated: | June 6, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shanghai Jiao Tong University School of Medicine:
|
NAFLD exercise hepatic triglycerides |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013