N/A
N=12
The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
Non-alcoholic Steatohepatitis · Non-alcoholic Fatty Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT02528305 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
May 2018
Primary outcome: Primary: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) — 6.9; 9.6; 7.0 units on a scale — p=0.474
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-intensity Interval Training (Other)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Bath
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) |
6.9; 9.6; 7.0 | 0.474 |
| PRIMARY Oral Glucose Tolerance Test |
981; 1030; 1010 | 0.174 |
| PRIMARY AST: ALT Ratio |
0.5; 0.5; 0.5 | 0.303 |
| PRIMARY FIB-4 |
0.68; 0.60; 0.60 | 0.023 sig |
| PRIMARY Body Fat Mass Estimated Via Bioimpedance |
29.7; 29.5; 28.3; 26.6; 29.1; 28.6 | 0.092 |
| PRIMARY Blood Pressure |
139; 142; 136; 85; 87; 78 | 0.771 |
| PRIMARY General Well-being as Assessed by SF-36 Questionnaire |
79; 85; 92; 78; 82; 83 | 0.099 |
| PRIMARY Short-term Memory Recall |
6; 7; 6 | 0.310 |
| PRIMARY Estimated VO2 Max |
34.9; 37.6; 38.5 | <0.001 sig |
| PRIMARY Physical Function-"Get up and go" Test |
6.61; 6.23; 5.87 | 0.005 sig |
| PRIMARY Ankle Brachial Pressure Index (ABPI) |
1.15; 1.08; 1.13 | 0.793 |
| PRIMARY Long-term Memory Recall |
4; 5; 5 | 0.513 |
| PRIMARY Executive Function (Verbal Fluency Test) |
8; 12; 11 | 0.009 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02528305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.