Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT03599934
Status:
COMPLETED
Last Update Posted:
2021-11-18
First Post:
2018-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Home Exercise on Reducing Falls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-17', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fall', 'timeFrame': '1.5 years', 'description': 'Prospective fall data will be collected through telephone follow-up for 1.5 year'}], 'secondaryOutcomes': [{'measure': 'Handgrip strength', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'Hand grip strength will be assessed by handheld dynamometer'}, {'measure': 'Functional lower body strength', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'Five-time sit-to-stand test will be used to assess lower body strength'}, {'measure': 'Single leg standing balance', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'Single leg standing balance of both legs will be assessed'}, {'measure': '10-meter walk test', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'The usual walking speed on a 10-meter walkway'}, {'measure': 'Timed-up and Go test', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'The time required to stand up from a chair, walk 3-m, return, and sit down, in comfortable speed'}, {'measure': 'Timed-up and Go test with dual-task', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'The timed-up and Go test would be tested while asking the participants to do serial-3-subtraction'}, {'measure': 'Montreal Cognitive Assessment 5-minute protocol', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'A standardized cognitive test'}, {'measure': 'Activity level', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'Selected participants will be asked to wear an activity tracker for 7 days to examine their activity level'}, {'measure': 'Fall risk', 'timeFrame': 'Baseline and follow-up assessment at 6-month', 'description': 'Physiological Profile Assessment (PPA) will be used to assess fall risk'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly', 'Exercise', 'Fall', 'Home safety'], 'conditions': ['Fall']}, 'descriptionModule': {'briefSummary': 'This proposed randomized controlled trial aims to study the long-term compliance of the LiFE program and its combined effects with a home safety visit on fall prevention in community-dwelling older fallers.', 'detailedDescription': 'This will be a single-blinded randomized controlled trial. The subjects will be randomly assigned to the LiFE exercise plus home safety assessment group, or the control group by a computer program operated by an independent researcher. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 60 or older\n* able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3\n* able to walk for ≥ 10 meters\n* history of falls in the past 12 months\n* living in the community\n* without MCI or dementia according to the 5-minute Montreal Cognitive assessment\n* have a moderate fall risk or above as assessed by the Physiological Profile Assessment\n* able to understand Chinese.\n\nExclusion Criteria:\n\n* blindness\n* diagnosis of mental disorders (e.g., severe depression, schizophrenia)\n* any contraindications to exercise (e.g. unstable angina).'}, 'identificationModule': {'nctId': 'NCT03599934', 'briefTitle': 'Effect of Home Exercise on Reducing Falls', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'The Effect of Lifestyle-integrated Functional Exercise Plus a Home Safety Visit on Reducing Falls in Community Older Fallers: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2017.400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LiFE training and home safety assessment', 'description': 'The participants will receive Lifestyle Integrated Functional Exercise Program and Home safety assessment', 'interventionNames': ['Other: Lifestyle integrated functional exercise program', 'Other: Home safety assessment']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will continue their usual daily routine.'}], 'interventions': [{'name': 'Lifestyle integrated functional exercise program', 'type': 'OTHER', 'description': 'Lifestyle-integrated exercise training targeting to improve strength and balance. Strategy to embed the exercise in the daily activity would also be taught so that the life exercise can be performed at any time of the day. The exercise would be taught in 6 home visits over 6-months.', 'armGroupLabels': ['LiFE training and home safety assessment']}, {'name': 'Home safety assessment', 'type': 'OTHER', 'description': 'Home safety assessment and modification that targets to reduce environmental risk factors of falls.', 'armGroupLabels': ['LiFE training and home safety assessment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Timothy Kwok, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Timothy Kwok', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}