Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
Study NCT ID:
NCT04133857
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2019-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Effects of HIIT and SSMIT on Intraocular Pressure Among Sedentary Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-15', 'size': 291614, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-17T02:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-17', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in intraocular pressure', 'timeFrame': '30 minutes', 'description': 'changes in intraocular pressure before and after exervcise'}], 'secondaryOutcomes': [{'measure': 'compare which form of exercise (HIIT & SSMIT) is superior in reducing intraocular pressure', 'timeFrame': '30 days', 'description': 'difference in intraocular pressure reduction observed between each exercise protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraocular Pressure']}, 'descriptionModule': {'briefSummary': 'Purpose to study the acute effects of both forms of aerobic exercise (HIIT and SSMIT) on intraocular pressure among healthy sedentary individuals', 'detailedDescription': '40 participants were recruited and divided into 2 groups. Each group performed 2 exercise protocols with a 4 day washout period between them.\n\nThe intraocular pressure was measured before the exercise and after the exercise in 5 minute periods up until 30 minutes post exercise.\n\nThe intraocular pressure was measured using a handheld rebound tonometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all University hospital staff\n\nExclusion Criteria:\n\n* previous ocular trauma\n* surgery in the eligible eye\n* known case of glaucoma or glaucoma suspect (IOP \\> 21mmHg)\n* history of glaucoma laser procedure/surgery within 6 months in eligible eye\n* unable to undergo IOP measurements\n* undiagnosed visual condition\n* any uncontrolled medical condition such as end stage renal failure, uncontrolled diabetes and uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT04133857', 'briefTitle': 'Acute Effects of HIIT and SSMIT on Intraocular Pressure Among Sedentary Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Acute Effects of High Intensity Interval Training (HIIT) and Steady State Moderate Intensity Training (SSMIT) on Intraocular Pressure Among Sedentary Individuals', 'orgStudyIdInfo': {'id': '20171031-5738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'undergo HIIT first then SSMIT protocol', 'interventionNames': ['Other: aerobic exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'undergo SSMIT first then HIIT protocol', 'interventionNames': ['Other: aerobic exercise']}], 'interventions': [{'name': 'aerobic exercise', 'type': 'OTHER', 'description': 'aerobic exercise HIIT : High intensity interval training SSMIT : Steady state moderate intensity training', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Wilayah Perseketuan', 'country': 'Malaysia', 'facility': 'University Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Prof Mohd Nahar Azmi Mohamed', 'investigatorAffiliation': 'University of Malaya'}}}}