Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT02528305
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2015-08-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'n.vollaard@stir.ac.uk', 'phone': '+441786466488', 'title': 'Dr Niels Vollaard', 'organization': 'University of Striling'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High-intensity Interval Training (HIT)', 'description': '6 week control period with no intervention then 6 weeks of twice weekly HIT\n\nHigh-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.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'notes': 'occurred at home during 6 week period of HIT intervention. Cardiologist concluded HIT had not contributed to his infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '4.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.474', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Oral Glucose Tolerance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '981', 'spread': '136', 'groupId': 'OG000'}, {'value': '1030', 'spread': '182', 'groupId': 'OG001'}, {'value': '1010', 'spread': '247', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.174', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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.', 'unitOfMeasure': 'mmol/L*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'AST: ALT Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.303', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'ratio of liver enzymes aspartate aminotransferase (AST) to alanine aminotransferase (ALT).\n\nused 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.\n\nRatio may rise as fibrosis and cirrhosis develop in viral hepatitis.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'FIB-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.60', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': "calculated from AST, ALT, platelets and participant's age and used to estimate amount of fibrosis in liver.\n\nFib-4 score of \\<1.45 has negative predictive value of 90% for advanced fibrosis.", 'unitOfMeasure': 'Fibrosis Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Body Fat Mass Estimated Via Bioimpedance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'title': 'total fat', 'categories': [{'measurements': [{'value': '29.7', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '29.5', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '28.3', 'spread': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'trunk fat', 'categories': [{'measurements': [{'value': '26.6', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '29.1', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '28.6', 'spread': '5.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.092', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Total body fat'}, {'pValue': '0.101', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Trunk fat'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'total body fat and trunk fat estimated via bioimpedance measured after overnight fast, expressed as percentage', 'unitOfMeasure': 'percentage body fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'title': 'systolic blood pressure', 'categories': [{'measurements': [{'value': '139', 'spread': '18', 'groupId': 'OG000'}, {'value': '142', 'spread': '13', 'groupId': 'OG001'}, {'value': '136', 'spread': '19', 'groupId': 'OG002'}]}]}, {'title': 'diastolic blood pressure', 'categories': [{'measurements': [{'value': '85', 'spread': '13', 'groupId': 'OG000'}, {'value': '87', 'spread': '10', 'groupId': 'OG001'}, {'value': '78', 'spread': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.771', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of systolic blood pressure'}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of diastolic blood pressure'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'taken with participant supine, measured on left arm', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'General Well-being as Assessed by SF-36 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'title': 'Physical Function', 'categories': [{'measurements': [{'value': '79', 'spread': '25', 'groupId': 'OG000'}, {'value': '85', 'spread': '22', 'groupId': 'OG001'}, {'value': '92', 'spread': '16', 'groupId': 'OG002'}]}]}, {'title': 'Social Function', 'categories': [{'measurements': [{'value': '78', 'spread': '31', 'groupId': 'OG000'}, {'value': '82', 'spread': '27', 'groupId': 'OG001'}, {'value': '83', 'spread': '27', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '71', 'spread': '17', 'groupId': 'OG000'}, {'value': '69', 'spread': '20', 'groupId': 'OG001'}, {'value': '77', 'spread': '20', 'groupId': 'OG002'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '78', 'spread': '13', 'groupId': 'OG000'}, {'value': '72', 'spread': '28', 'groupId': 'OG001'}, {'value': '88', 'spread': '16', 'groupId': 'OG002'}]}]}, {'title': 'Change in Health', 'categories': [{'measurements': [{'value': '50', 'spread': '18', 'groupId': 'OG000'}, {'value': '53', 'spread': '15', 'groupId': 'OG001'}, {'value': '67', 'spread': '18', 'groupId': 'OG002'}]}]}, {'title': 'Physical Role Limitation', 'categories': [{'measurements': [{'value': '79', 'spread': '27', 'groupId': 'OG000'}, {'value': '79', 'spread': '31', 'groupId': 'OG001'}, {'value': '90', 'spread': '22', 'groupId': 'OG002'}]}]}, {'title': 'Mental Role Limitation', 'categories': [{'measurements': [{'value': '76', 'spread': '24', 'groupId': 'OG000'}, {'value': '76', 'spread': '34', 'groupId': 'OG001'}, {'value': '81', 'spread': '30', 'groupId': 'OG002'}]}]}, {'title': 'Energy/Vitality', 'categories': [{'measurements': [{'value': '58', 'spread': '18', 'groupId': 'OG000'}, {'value': '56', 'spread': '20', 'groupId': 'OG001'}, {'value': '64', 'spread': '21', 'groupId': 'OG002'}]}]}, {'title': 'Health Perception', 'categories': [{'measurements': [{'value': '58', 'spread': '19', 'groupId': 'OG000'}, {'value': '60', 'spread': '17', 'groupId': 'OG001'}, {'value': '61', 'spread': '17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.099', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Physical Function'}, {'pValue': '0.566', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Social Function'}, {'pValue': '0.246', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Mental Health'}, {'pValue': '0.145', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Pain'}, {'pValue': '0.085', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Change in Health'}, {'pValue': '0.114', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Physical Role Limitation'}, {'pValue': '0.841', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Mental Role Limitation'}, {'pValue': '0.366', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Energy/Vitality'}, {'pValue': '0.745', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For the analysis of Health Perception'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Short-term Memory Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '2', 'groupId': 'OG000'}, {'value': '7', 'spread': '1', 'groupId': 'OG001'}, {'value': '6', 'spread': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.310', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'testing of verbal word presentation-immediate recall of 10 words (60 seconds for recall) Maximum =10, minimum =0', 'unitOfMeasure': 'words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Estimated VO2 Max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '38.5', 'spread': '7.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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)', 'unitOfMeasure': 'millilitres/kilogram/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Physical Function-"Get up and go" Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '6.61', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '6.23', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '5.87', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ankle Brachial Pressure Index (ABPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.793', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'ratio of blood pressure in left arm and right ankle', 'unitOfMeasure': 'ABPI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Long-term Memory Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '1', 'groupId': 'OG000'}, {'value': '5', 'spread': '2', 'groupId': 'OG001'}, {'value': '5', 'spread': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.513', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'testing of verbal word presentation-delayed recall of 10 words 10 minutes after words initially presented (within 60 seconds).\n\nMaximum= 10 words, minimum = no words', 'unitOfMeasure': 'words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Executive Function (Verbal Fluency Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Assessment', 'description': 'on entry to trial'}, {'id': 'OG001', 'title': 'After 6 Week Control Period', 'description': 'repeat assessment after 6 weeks of no intervention'}, {'id': 'OG002', 'title': 'After HIT Assessment', 'description': 'final assessment within 1 week of completing 6 weeks of HIT'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '4', 'groupId': 'OG000'}, {'value': '12', 'spread': '4', 'groupId': 'OG001'}, {'value': '11', 'spread': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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.\n\nBaseline assessment-letter A Post Control assessment -letter S After HIT assessment -letter F', 'unitOfMeasure': 'words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-intensity Interval Training (HIT)', 'description': '6 week control period with no intervention then 6 weeks of twice weekly HIT\n\nHigh-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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'End of Control Period Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'End of Intervention Period Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'High-intensity Interval Training (HIT)', 'description': '6 week control period with no intervention then 6 weeks of twice weekly HIT\n\nHigh-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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'height', 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '0.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'metres', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '3.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'diagnosis', 'classes': [{'title': 'Non-alcoholic Fatty Liver Disease (NAFLD)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Non-alcoholic Steatohepatitis (NASH)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No Masking, this was not possible with this study design.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2015-08-10', 'resultsFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-03', 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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'}, {'measure': 'Oral Glucose Tolerance Test', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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.'}, {'measure': 'AST: ALT Ratio', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'ratio of liver enzymes aspartate aminotransferase (AST) to alanine aminotransferase (ALT).\n\nused 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.\n\nRatio may rise as fibrosis and cirrhosis develop in viral hepatitis.'}, {'measure': 'FIB-4', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': "calculated from AST, ALT, platelets and participant's age and used to estimate amount of fibrosis in liver.\n\nFib-4 score of \\<1.45 has negative predictive value of 90% for advanced fibrosis."}, {'measure': 'Body Fat Mass Estimated Via Bioimpedance', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'total body fat and trunk fat estimated via bioimpedance measured after overnight fast, expressed as percentage'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'taken with participant supine, measured on left arm'}, {'measure': 'General Well-being as Assessed by SF-36 Questionnaire', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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'}, {'measure': 'Short-term Memory Recall', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'testing of verbal word presentation-immediate recall of 10 words (60 seconds for recall) Maximum =10, minimum =0'}, {'measure': 'Estimated VO2 Max', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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)'}, {'measure': 'Physical Function-"Get up and go" Test', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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.'}, {'measure': 'Ankle Brachial Pressure Index (ABPI)', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'ratio of blood pressure in left arm and right ankle'}, {'measure': 'Long-term Memory Recall', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': 'testing of verbal word presentation-delayed recall of 10 words 10 minutes after words initially presented (within 60 seconds).\n\nMaximum= 10 words, minimum = no words'}, {'measure': 'Executive Function (Verbal Fluency Test)', 'timeFrame': 'Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks', 'description': '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.\n\nBaseline assessment-letter A Post Control assessment -letter S After HIT assessment -letter F'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High-intensity Interval Training'], 'conditions': ['Non-alcoholic Steatohepatitis', 'Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nAssessments 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.\n\nThe 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.\n\nAt least 3 days after the last HIT session the pre-intervention testing assessment will be repeated for a third time.\n\nChanges in measured variables will be analysed via repeated measures analysis of variance (ANOVA) with post-hoc testing of all variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis\n* attending a specialist liver clinic at Ninewells Hospital, Dundee\n\nExclusion Criteria:\n\n* unstable cardiovascular disease\n* uncontrolled arrhythmias\n* structural cardiac abnormalities\n* uncontrolled diabetes\n* other uncontrolled metabolic abnormalities\n* severe orthopaedic condition that would prohibit exercise\n* severe pulmonary condition that would prohibit exercise\n* any other poorly controlled medical condition.\n* resting systolic blood pressure above 160 mm Hg\n* resting diastolic blood pressure above 90 mm Hg\n* symptomatic postural drop in blood pressure greater than 20 mm Hg'}, 'identificationModule': {'nctId': 'NCT02528305', 'briefTitle': 'The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Bath'}, 'officialTitle': 'A Pilot Project to Assess the Effect of High-intensity Interval Training in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis', 'orgStudyIdInfo': {'id': '2015CM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity Interval Training (HIT)', 'description': '6 week control period with no intervention then 6 weeks of twice weekly HIT', 'interventionNames': ['Other: High-intensity Interval Training']}], 'interventions': [{'name': 'High-intensity Interval Training', 'type': 'OTHER', 'otherNames': ['Exercise'], 'description': '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.', 'armGroupLabels': ['High-intensity Interval Training (HIT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 1HG', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Abertay University', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Niels BJ Vollaard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bath'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no reason to share the IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bath', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abertay University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Human and Applied Physiology', 'investigatorFullName': 'Niels Vollaard', 'investigatorAffiliation': 'University of Bath'}}}}