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Feasibility of VIIT in Adults With NASH

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ClinicalTrials.gov Identifier: NCT03861819
Recruitment Status : Completed
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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 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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis Liver Diseases Behavioral: Vigorous-intensity interval training (VIIT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of Vigorous-Intensity Interval Training in Adults With Nonalcoholic Steatohepatitis
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 7, 2018
Actual Study Completion Date : December 7, 2018


Arm Intervention/treatment
Experimental: VIIT Intervention
This is a single-arm trial. The intervention itself proceeds as follows: After approximately 5 minutes of warmup subjects will perform 10 intervals of VIIT: 30 seconds of vigorous intensity exercise followed by 60 seconds of rest. Rated Perceived Exertion (RPE) will be rated by 15-point Borg scale; should correspond to HR/10 at end of each interval. The subject will self-adjust the intensity of the exercise bouts and will be encouraged by the researcher to achieve the desired intensity. The exercise session will finish with a short cool-down period and will last no more than 25 minutes in total.
Behavioral: Vigorous-intensity interval training (VIIT)
Subjects will be fitted with a heart rate monitor around the chest and a baseline 4ml blood sample will be drawn. Vigorous intensity interval training will correspond to heart rate (HR) range of 80-90% of heart rate at age-predicted heart rate maximum (220-age). After approximately 5 minutes of warmup subjects will perform 10 intervals of VIIT: 30 seconds of vigorous intensity exercise followed by 60 seconds of rest. Rated Perceived Exertion (RPE) will be rated by 15-point Borg scale; should correspond to HR/10 at end of each interval. The subject will self-adjust the intensity of the exercise bouts and will be encouraged by the researcher to achieve the desired intensity. The exercise session will finish with a short cool-down period and will last no more than 25 minutes in total. A 4ml blood sample will be drawn immediately following the exercise session and 2-hours after exercise cessation.




Primary Outcome Measures :
  1. Feasibility as measured by adherence to the intervention. [ Time Frame: Feasibility will be assessed after all subjects have completed the study, after a 12-month recruiting period. ]
    This study is designed to assess the feasibility of a VIIT intervention for adults with NASH-related fibrosis. Adherence will be measured as the % of subjects who are able to achieve the protocol target of 80% of their max heart rate during the intervention.

  2. Feasibility as measured by ease of recruiting [ Time Frame: Feasibility will be assessed after all subjects have completed the study, after a 12-month recruiting period. ]
    This study is designed to assess the feasibility of a VIIT intervention for adults with NASH-related fibrosis. Ease of recruiting will be determined by assessing whether the accrual target was met within the 12-month recruitment timeline.


Secondary Outcome Measures :
  1. Change in myokine response [ Time Frame: Secondary outcome measures will be assessed immediately post-exercise and 2-hours following exercise. ]
    The secondary outcome will be the change is 1L-6 and IL-8 cytokine response before and after the intervention.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861819


Locations
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United States, North Carolina
Duke Integrative Medicine
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03861819     History of Changes
Other Study ID Numbers: Pro00087286
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases