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

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ClinicalTrials.gov Identifier: NCT02528305
Recruitment Status : Completed
First Posted : August 19, 2015
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Abertay University
Information provided by (Responsible Party):
Niels Vollaard, University of Bath

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease Other: High-intensity Interval Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: No Masking, this was not possible with this study design.
Primary Purpose: Treatment
Official Title: A Pilot Project to Assess the Effect of High-intensity Interval Training in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: High-intensity Interval Training (HIT)
6 week control period with no intervention then 6 weeks of twice weekly HIT
Other: 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.
Other Name: Exercise




Primary Outcome Measures :
  1. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    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

  2. Oral Glucose Tolerance Test [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    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.

  3. AST: ALT Ratio [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]

    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.


  4. FIB-4 [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]

    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.


  5. Body Fat Mass Estimated Via Bioimpedance [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    total body fat and trunk fat estimated via bioimpedance measured after overnight fast, expressed as percentage

  6. Blood Pressure [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    taken with participant supine, measured on left arm

  7. General Well-being as Assessed by SF-36 Questionnaire [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    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

  8. Short-term Memory Recall [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    testing of verbal word presentation-immediate recall of 10 words (60 seconds for recall) Maximum =10, minimum =0

  9. Estimated VO2 Max [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    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)

  10. Physical Function-"Get up and go" Test [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    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.

  11. Ankle Brachial Pressure Index (ABPI) [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]
    ratio of blood pressure in left arm and right ankle

  12. Long-term Memory Recall [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]

    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


  13. Executive Function (Verbal Fluency Test) [ Time Frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528305


Locations
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United Kingdom
Abertay University
Dundee, United Kingdom, DD1 1HG
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Bath
Abertay University
Investigators
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Principal Investigator: Niels BJ Vollaard, PhD University of Bath

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Responsible Party: Niels Vollaard, Lecturer in Human and Applied Physiology, University of Bath
ClinicalTrials.gov Identifier: NCT02528305     History of Changes
Other Study ID Numbers: 2015CM
First Posted: August 19, 2015    Key Record Dates
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no reason to share the IPD.

Keywords provided by Niels Vollaard, University of Bath:
High-intensity Interval Training

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases