Status:
COMPLETED
Feasibility of VIIT in Adults With NASH
Lead Sponsor:
Duke University
Conditions:
Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic Fatty Liver
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether patients with stage 1-3 NASH-related fibrosis are able to complete a single vigorous-intensity interval training (VIIT) session on an indoor rowing ma...
Detailed Description
Background \& Significance: The increasing prevalence of obesity and diabetes has prompted a global epidemic of nonalcoholic fatty liver disease affecting 15-30% of the general population. Of those w...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Ages 18-59
- Histologically confirmed nonalcoholic steatohepatitis and fibrosis (stage 1-3) from liver biopsy
- Able to row on an indoor rowing apparatus
- Not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week)
- Not actively trying to lose weight through a dietary approach
- No absolute contra-indications to exercise: recent (\<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection
- No other form of chronic liver disease (as confirmed by serology and histology)
- No liver cirrhosis (stage 4 fibrosis on liver biopsy) or a clinical diagnosis of cirrhosis as ascertained by a hepatologist
- No coronary artery disease or chronic obstructive pulmonary disease.
- No diagnosis of malignancy (except non-melanoma skin cancer)
- No past or present history of portal hypertension (esophageal varices, ascites, hepatic encephalopathy)
- No use of immunosuppression or chronic nonsteroidal anti-inflammatory medication
- No more than 14 drinks per week (if male) or 7 drinks a week (if female) in the last 2 years
- Cognitively able to provide consent
- Able to read, write, and understand English
- Transportation to the exercise and testing facility
Exclusion
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03861819
Start Date
January 1 2018
End Date
December 7 2018
Last Update
March 4 2019
Active Locations (1)
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1
Duke Integrative Medicine
Durham, North Carolina, United States, 27705