Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT05551000
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2022-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional vs Traditional Training in Older Women's Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mobility test', 'timeFrame': 'Day 1', 'description': 'Chair-sit-and-reach and back scratch test (Cm)'}, {'measure': 'Mobility test', 'timeFrame': '2 months', 'description': 'Chair-sit-and-reach and back scratch test (Cm)'}, {'measure': 'Y-Balance Test', 'timeFrame': 'Day 1', 'description': 'Measure balance performance (Cm)'}, {'measure': 'Y-Balance Test', 'timeFrame': '2 months', 'description': 'Measure balance performance (Cm)'}, {'measure': 'Strength Test', 'timeFrame': 'Day 1', 'description': 'Chair stand and Arm curl test (Repetitions)'}, {'measure': 'Functional Strength Test', 'timeFrame': '2 months', 'description': 'Chair stand and Arm curl test (Repetitions)'}, {'measure': 'Time up-and-go test', 'timeFrame': 'Day 1', 'description': 'Measure agility (Secounds)'}, {'measure': 'Time up-and-go test', 'timeFrame': '2 months', 'description': 'Measure agility (Secounds)'}, {'measure': '6-minute walking test', 'timeFrame': 'Day 1', 'description': 'Measure walking distance (Meters)'}, {'measure': '6-minute walking test', 'timeFrame': '2 months', 'description': 'Measure walking distance (Meters)'}, {'measure': 'SF-36 questionnaire', 'timeFrame': '1 day', 'description': "Measure the participant's Health-related quality of life"}], 'secondaryOutcomes': [{'measure': 'SF-36 questionnaire', 'timeFrame': '2 months', 'description': "Measure the participant's Health-related quality of life"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Performance Enhancement']}, 'descriptionModule': {'briefSummary': 'This study investigates how balance, mobility, strength, gait speed, and health-related quality of life in older adults (65+) are affected after an 8-week training period using the Norwegian national concept for older adults, Strong and Steady, compared to a modified version that incorporates functional training variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderlies aged 65 to 75 years old.\n* Have been participating and physical training for at least six months before the start of the intervention.\n* The participants must be highly motivated for the project, which will be measured using the likard scale.\n\nExclusion Criteria:\n\n* Illness or injury within the last three months.\n* Do not have the ability to complete the test battery concerning set minimum criteria'}, 'identificationModule': {'nctId': 'NCT05551000', 'briefTitle': "Functional vs Traditional Training in Older Women's Health", 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Effects of Functional and Traditional Groups Class Training on Function and Health Among Female Older Adults: A Cluster-Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '438956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This group will use a functional training system developed specifically for elderlies to improve everyday movements, physical strength and balance.', 'interventionNames': ['Other: Experimental, comparator and control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive control', 'description': 'This group will use a general training system developed for elderlies to improve everyday movements, physical strength and balance.', 'interventionNames': ['Other: Experimental, comparator and control']}, {'type': 'NO_INTERVENTION', 'label': 'Negative control', 'description': 'Control group: A group that is not treated.'}], 'interventions': [{'name': 'Experimental, comparator and control', 'type': 'OTHER', 'description': 'To quantify the effect of a training intervention for elderlies on improved range of motion, dynamic balance, gait speed, gait coordination, everyday movements and strength compared to a training group from the Norwegian elderly concept "Stærk og Stødig" and a control group.', 'armGroupLabels': ['Intervention', 'Positive control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7714', 'city': 'Steinkjer', 'country': 'Norway', 'facility': 'SSA Steinkjer', 'geoPoint': {'lat': 64.01487, 'lon': 11.49537}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Research Council of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D. candidate', 'investigatorFullName': 'Lasse Engberg Treu Lassen', 'investigatorAffiliation': 'Aalborg University'}}}}