The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis

NCT ID: NCT02528305

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-intensity Interval Training (HIT)

6 week control period with no intervention then 6 weeks of twice weekly HIT

Group Type: EXPERIMENTAL

High-intensity Interval Training

Intervention Type: OTHER

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.

Interventions

High-intensity Interval Training

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.

Intervention Type: OTHER

Other Intervention Names

Exercise

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abertay University

OTHER

Sponsor Role: collaborator

University of Bath

OTHER

Sponsor Role: lead

Responsible Party

Niels Vollaard

Lecturer in Human and Applied Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niels BJ Vollaard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bath

Locations

Abertay University

Dundee, , United Kingdom

Ninewells Hospital

Dundee, , United Kingdom

Countries

United Kingdom

Other Identifiers

2015CM

Identifier Type: -

Identifier Source: org_study_id