Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT04053920
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2019-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resistance Exercise Training at Different Intensities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'Knee extensor maximal torque during an isometric MVC'}], 'secondaryOutcomes': [{'measure': 'Vastus lateralis muscle thickness', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'Measured via ultrasound'}, {'measure': 'Muscle strength', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'Knee flexor maximal torque during an isometric MVC'}, {'measure': 'One-repetition maximum', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'leg extension, leg curl, leg press and calf press'}, {'measure': 'Biomechanics during walking and stair climbing', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'Motion analysis'}, {'measure': 'Short performance physical battery test', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'SPPB - balance, walking pace and chair rise'}, {'measure': 'Quality of life measure', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'EQ-5D-5L questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia', 'Frailty', 'Aging']}, 'descriptionModule': {'briefSummary': 'The aim of the current study, therefore, is to determine the feasibility of recruitment and adherence to resistance exercise training interventions performed at low and high loads, to volitional muscular failure, in a trial population that includes both healthy and frail older people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over age of 65 years\n\nExclusion Criteria:\n\n* Current participation in an exercise programme\n* Exercise deemed unsafe by clinical team'}, 'identificationModule': {'nctId': 'NCT04053920', 'briefTitle': 'Resistance Exercise Training at Different Intensities', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study', 'orgStudyIdInfo': {'id': '236559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low load', 'description': 'Training at 30-40% one-repetition maximum (1RM)', 'interventionNames': ['Behavioral: Low Load Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': 'High load', 'description': 'Training at 65-75% one-repetition maximum (1RM)', 'interventionNames': ['Behavioral: High Load Resistance exercise']}], 'interventions': [{'name': 'Low Load Resistance exercise', 'type': 'BEHAVIORAL', 'description': 'leg extension, leg press, leg curl and calf press', 'armGroupLabels': ['Low load']}, {'name': 'High Load Resistance exercise', 'type': 'BEHAVIORAL', 'description': 'leg extension, leg press, leg curl and calf press', 'armGroupLabels': ['High load']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 8TA', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'GRI Clinical Research Facility', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Stuart Gray', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer in Exercise and Metabolic Health', 'investigatorFullName': 'Stuart Gray', 'investigatorAffiliation': 'University of Glasgow'}}}}