Clinical trial NCT02528305: The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
Official title: A Pilot Project to Assess the Effect of High-intensity Interval Training in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Steatohepatitis
Non-alcoholic Fatty Liver Disease
Keywords: High-intensity Interval Training
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: Abertay University
First posted: 2015-08-19
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
* attending a specialist liver clinic at Ninewells Hospital, Dundee

Exclusion Criteria:

* unstable cardiovascular disease
* uncontrolled arrhythmias
* structural cardiac abnormalities
* uncontrolled diabetes
* other uncontrolled metabolic abnormalities
* severe orthopaedic condition that would prohibit exercise
* severe pulmonary condition that would prohibit exercise
* any other poorly controlled medical condition.
* resting systolic blood pressure above 160 mm Hg
* resting diastolic blood pressure above 90 mm Hg
* symptomatic postural drop in blood pressure greater than 20 mm Hg

Primary outcomes:
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Oral Glucose Tolerance Test
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: AST: ALT Ratio
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: FIB-4
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Body Fat Mass Estimated Via Bioimpedance
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Blood Pressure
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: General Well-being as Assessed by SF-36 Questionnaire
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Short-term Memory Recall
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Estimated VO2 Max
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Physical Function-"Get up and go" Test
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Ankle Brachial Pressure Index (ABPI)
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Long-term Memory Recall
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
measure: Executive Function (Verbal Fluency Test)
timeFrame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Abertay University
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
Study officials:
affiliation: University of Bath
name: Niels BJ Vollaard, PhD
role: PRINCIPAL_INVESTIGATOR
References: