Feasibility of VIIT in Adults With NASH
Completed · Not applicable
Conditions studied: Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Liver Diseases
In brief
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 machine and provide blood samples before and afterwards. The results of this study will provide the foundation for future research on the role of VIIT in treating NASH.
Key facts
- Study ID
- NCT03861819
- Run by
- Duke University
- People needed
- 24
- Starts
- 2018-01-01
- Expected to finish
- 2018-12-07
- Last updated by the study team
- 2019-03-04
Who can join
Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Duke Integrative Medicine — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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