Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT03545802
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2018-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home-HIT and Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-26', 'studyFirstSubmitDate': '2018-05-09', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in maximal aerobic capacity', 'timeFrame': 'change in baseline maximal aerobic capacity at 6 weeks', 'description': 'Maximal aerobic capacity was measured pre and post 6 week training intervention using a MOXUS gas analyser on a stationary cycle ergometer'}, {'measure': 'adherence over the course of the training programme', 'timeFrame': 'adherence to the training programme over the course of the 6 week intervention', 'description': 'session completion rate (adherence) was assessed'}, {'measure': 'Compliance over the course of the training programme', 'timeFrame': 'compliance to the training programme over the course of the 6 week intervention', 'description': 'ability to meet target heart rates (compliance) was assessed'}], 'secondaryOutcomes': [{'measure': 'change in insulin sensitivity', 'timeFrame': 'change in baseline insulin sensitivity at 6 weeks', 'description': 'insulin dose was recorded pre and post training by participants'}, {'measure': 'change in glycaemic control', 'timeFrame': 'change in baseline glycaemic control at 6 weeks', 'description': 'participants recorded their blood glucose concentrations in the first and final weeks of the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1diabetes']}, 'referencesModule': {'references': [{'pmid': '31530660', 'type': 'DERIVED', 'citation': 'Scott SN, Shepherd SO, Andrews RC, Narendran P, Purewal TS, Kinnafick F, Cuthbertson DJ, Atkinson-Goulding S, Noon T, Wagenmakers AJM, Cocks M. A Multidisciplinary Evaluation of a Virtually Supervised Home-Based High-Intensity Interval Training Intervention in People With Type 1 Diabetes. Diabetes Care. 2019 Dec;42(12):2330-2333. doi: 10.2337/dc19-0871. Epub 2019 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to use a multi-disciplinary approach to evaluate a 6-week home-based high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.', 'detailedDescription': 'This study aimed to use a multi-disciplinary approach to evaluate a home-based high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.\n\nEleven individuals with type 1 diabetes (4 men/7 women; age 30±3 years; BMI 27.1±1.2 kg·m-2; V ̇O2peak 32.4±2.1 ml∙kg∙min-1; duration of type 1 diabetes 10±2 years) completed six weeks of Home-HIT. The effect of Home-HIT on V ̇O2peak, blood pressure, insulin dose and glycaemic profile was assessed pre and post-training. Adherence and ability to meet target heart rate (HR) thresholds (compliance) were monitored using a HR monitor and mobile phone application. Change in glycaemia was measured pre, post and 1h post exercise sessions throughout the six-week period. A qualitative online survey was completed post-training.\n\nThis is the first study to combine physiological outcomes with a qualitative evaluation of a training intervention in people with type 1 diabetes. Home-HIT resulted in high adherence alongside increased V ̇O2peak and decreased insulin dose. Because Home-HIT is time-efficient and removes barriers to exercise including fear of hypoglycaemia, it may represent an effective strategy to increase exercise participation in people with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* duration of type 1 diabetes \\>6 months,\n* no significant history of hyper- or hypoglycaemia\n\nExclusion Criteria:\n\n* duration of type 1 diabetes \\<6 months,\n* significant history of hyper- or hypoglycaemia,\n* pregnancy or planning pregnancy,\n* uncontrolled hypertension (\\>180/100 mmHg),\n* angina\n* autonomic neuropathy,\n* taking any medication that affects heart rate (HR)\n* major surgery planned within 6 weeks of the study\n* severe nonproliferative\n* unstable proliferative retinopathy'}, 'identificationModule': {'nctId': 'NCT03545802', 'briefTitle': 'Home-HIT and Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Liverpool John Moores University'}, 'officialTitle': 'A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study', 'orgStudyIdInfo': {'id': 'Home-HIT_T1D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'description': '6 weeks of home-based high intensity interval training', 'interventionNames': ['Behavioral: Home-HIT']}], 'interventions': [{'name': 'Home-HIT', 'type': 'BEHAVIORAL', 'description': 'Participants completed 6 weeks of home-based high-intensity interval training 3 times per week', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L3 3AF', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Liverpool John Moores University', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool John Moores University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer/Senior Lecturer, Principle Investigator', 'investigatorFullName': 'Sam Shepherd', 'investigatorAffiliation': 'Liverpool John Moores University'}}}}