- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02528305
The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
A Pilot Project to Assess the Effect of High-intensity Interval Training in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dundee, United Kingdom, DD1 9SY
- Ninewells Hospital
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Dundee, United Kingdom, DD1 1HG
- Abertay University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-intensity Interval Training (HIT)
6 week control period with no intervention then 6 weeks of twice weekly HIT
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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Oral Glucose Tolerance Test
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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.
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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AST: ALT Ratio
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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
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FIB-4
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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
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Body Fat Mass Estimated Via Bioimpedance
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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total body fat and trunk fat estimated via bioimpedance measured after overnight fast, expressed as percentage
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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Blood Pressure
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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taken with participant supine, measured on left arm
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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General Well-being as Assessed by SF-36 Questionnaire
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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Short-term Memory Recall
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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testing of verbal word presentation-immediate recall of 10 words (60 seconds for recall) Maximum =10, minimum =0
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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Estimated VO2 Max
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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)
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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Physical Function-"Get up and go" Test
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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.
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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Ankle Brachial Pressure Index (ABPI)
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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ratio of blood pressure in left arm and right ankle
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Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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Long-term Memory Recall
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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
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Executive Function (Verbal Fluency Test)
Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Niels BJ Vollaard, PhD, University of Bath
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015CM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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