Non-alcoholic SteatohepatitisNCT02528305
The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
A study testing High-intensity Interval Training in people with Non-alcoholic Steatohepatitis and Non-alcoholic Fatty Liver Disease, run by University of Bath at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
- What is being tested?
- High-intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
- attending a specialist liver clinic at Ninewells Hospital, Dundee
Who cannot join
- unstable cardiovascular disease
- uncontrolled arrhythmias
- structural cardiac abnormalities
- uncontrolled diabetes
- other uncontrolled metabolic abnormalities
- severe orthopaedic condition that would prohibit exercise
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Abertay University
Dundee, DD1 1HG
Ninewells Hospital
Dundee, DD1 9SY
About this study
Official title: A Pilot Project to Assess the Effect of High-intensity Interval Training in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
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.
Read the 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.
- Being tested
- High-intensity Interval Training
- Keywords
- High-intensity Interval Training
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity Interval TrainingOther
Also called Exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity Interval Training (HIT) | Experimental | 6 week control period with no intervention then 6 weeks of twice weekly HIT Receives: Other: High-intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Blood Pressure
taken with participant supine, measured on left arm
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Abertay University
- Responsible party
- Principal investigator, Niels Vollaard, University of Bath
- Investigators
- Niels BJ Vollaard, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528305
- Sponsor's protocol ID
- 2015CM
- Status last verified
- May 2018
- First submitted
- 10 Aug 2015
- Last updated
- 4 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is no reason to share the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Project to Assess the Effect of High-intensity Interval Training in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
- ClinicalTrials.gov ID
- NCT02528305
- Acronym / sponsor ID
- 2015CM
- Keywords
- High-intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Abertay University
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 4 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-intensity Interval Training (HIT) | Experimental | Other: High-intensity Interval Training6 week control period with no intervention then 6 weeks of twice weekly HIT |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
- attending a specialist liver clinic at Ninewells Hospital, Dundee
Key exclusion criteria (11 listed)
- unstable cardiovascular disease
- uncontrolled arrhythmias
- structural cardiac abnormalities
- uncontrolled diabetes
- other uncontrolled metabolic abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity Interval TrainingAlso: Exercise2 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 | High-intensity Interval Training (HIT) |
Primary outcome
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
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.
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.
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.
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
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
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
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
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)
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.
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no reason to share the IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels BJ Vollaard, PhD principal investigator
University of Bath
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity Interval Training in people with Non-alcoholic Steatohepatitis and Non-alcoholic Fatty Liver Disease, run by University of Bath at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) (time frame: Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.