The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
Condition: Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This pilot study aims to investigate whether 6 weeks of twice weekly High-intensity Interval
      Training (HIT) results in improvements in disease-specific measures, feelings of general
      well-being, physical fitness and cognitive function in patients with non-alcoholic fatty
      liver disease or non-alcoholic steatohepatitis.
    

Detailed description: 
      The study aims to recruit up to 12 patients diagnosed with non-alcoholic fatty liver disease
      (NAFLD) or non-alcoholic steatohepatitis (NASH) from the liver clinics at Ninewells Hospital,
      Dundee. Suitable patients who give informed consent will be assessed at baseline, again after
      6 weeks of no intervention to act as a control period, and thirdly after 6 weeks of
      twice-weekly high-intensity interval training (HIT).

      Assessments will be performed with the patient fasted overnight, and will involve body
      composition measurements, blood pressure, a venous blood sample for circulating
      triglycerides, fasting glucose, insulin, liver enzymes alanine aminotransferase (ALT) and
      aspartate aminotransferase (AST), and platelets. An oral glucose tolerance test will be
      performed using fingerprick capillary samples. Cognitive function tests for episodic memory,
      executive function and semantic memory will be performed and a questionnaire (SF-36) will be
      used to assess general well-being. Physical fitness will be assessed through a 12-minute walk
      test on a treadmill, which will allow estimation of maximal oxygen uptake capacity (VO2 max),
      and a "get up and go" test will be used to assess physical function.

      The exercise intervention will involve a 2 minute warm-up, cycling at 50 rpm before the
      participants will be asked to cycle at 100rpm and a weight will be added (7% body weight for
      men and 6% body weight for women) as resistance. The sprint will last 6 seconds and the
      participant will be asked to rest for at least 1 minute. This will be repeated for a total of
      5 sprints in sessions 1-3, 6 sprints in session 4, 7 sprints in sessions 5&6, 8 sprints in
      sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12. Exercise heart
      rate will be monitored and recorded.

      At least 3 days after the last HIT session the pre-intervention testing assessment will be
      repeated for a third time.

      Changes in measured variables will be analysed via repeated measures analysis of variance
      (ANOVA) with post-hoc testing of all variables.
    

Intervention name(s): High-intensity Interval Training
Intervention type(s): Other
Intervention description(s): 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12.
Other intervention name(s): Exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High-intensity Interval Training