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

NCT02528305 | Completed Results

• 1 other identifier: 2015CM
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease

Keywords

High-intensity Interval Training

Outcome Measures

Primary Outcomes (13)

• Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  calculation of insulin resistance via formula: fasting insulin (mIU/L) x fasting glucose (mg/dL)/405 normal insulin resistance -HOMA score \<3 moderate insulin resistance -HOMA score 3-5 severe insulin resistance -HOMA score \>5 Assessed at baseline, after 6 week control period and within 1 week of completing 6 weeks HIT

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Oral Glucose Tolerance Test

  measurement of capillary samples for glucose at time 0, followed by every 20 minutes for 2 hours following ingestion of 75g glucose. Results graphed against time, then area under the curve calculated for each of the 3 assessments.

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• AST: ALT Ratio

  ratio of liver enzymes aspartate aminotransferase (AST) to alanine aminotransferase (ALT). used as a diagnostic aid e.g. AST:ALT of more than 2:1 is characteristic of alcoholic liver disease whereas fatty steatosis and many other causes of liver disease, ratio is less than or equal to 1. Ratio may rise as fibrosis and cirrhosis develop in viral hepatitis.

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• FIB-4

  calculated from AST, ALT, platelets and participant's age and used to estimate amount of fibrosis in liver. Fib-4 score of \<1.45 has negative predictive value of 90% for advanced fibrosis.

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Body Fat Mass Estimated Via Bioimpedance

  total body fat and trunk fat estimated via bioimpedance measured after overnight fast, expressed as percentage

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Blood Pressure

  taken with participant supine, measured on left arm

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• General Well-being as Assessed by SF-36 Questionnaire

  Assessment of: physical functioning, social functioning, mental health, pain, change in health, physical role limitation, mental role limitation, energy and vitality, health perception over preceding 4 weeks (other than change in health, which is a comparison to health the preceding year), expressed as a transformed score range 0-100, with a higher score indicating better function/freedom from pain etc

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Short-term Memory Recall

  testing of verbal word presentation-immediate recall of 10 words (60 seconds for recall) Maximum =10, minimum =0

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Estimated VO2 Max

  VO2 max estimated via submaximal exercise test-submaximal treadmill walking test Calculated via formula: VO2max= 15.1+21.8 x speed (miles per hour) - 0.327 x heart rate (beats per minute) - 0.263 x speed x age (years) + 0.00504 x heart rate x age + 5.98 x gender (0=female, 1=male)

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Physical Function-"Get up and go" Test

  participant will be timed standing up from chair unaided,walking 30m, turning round and returning to a seated position on the chair, the average time of 3 attempts will be recorded.

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Ankle Brachial Pressure Index (ABPI)

  ratio of blood pressure in left arm and right ankle

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Long-term Memory Recall

  testing of verbal word presentation-delayed recall of 10 words 10 minutes after words initially presented (within 60 seconds). Maximum= 10 words, minimum = no words

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

• Executive Function (Verbal Fluency Test)

  written verbal fluency test: participant asked to write down as many English words as possible within 60 seconds, starting with a particular letter of the alphabet, excluding proper nouns or plurals. Baseline assessment-letter A Post Control assessment -letter S After HIT assessment -letter F

  Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks

Study Arms (1)

High-intensity Interval Training (HIT)

EXPERIMENTAL

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

Other: High-intensity Interval Training

Interventions

High-intensity Interval Training 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.

Also known as: Exercise

High-intensity Interval Training (HIT)

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead
• Abertay University: collaborator

Study Sites (2)

Abertay University

Dundee, DD1 1HG, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

High-Intensity Interval Training; Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr Niels Vollaard
• Organization: University of Striling

n.vollaard@stir.ac.uk

+441786466488

Study Officials

• Niels BJ Vollaard, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking, this was not possible with this study design.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Human and Applied Physiology

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 19, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 4, 2018
• Results First Posted: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)