Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-04-01 @ 9:15 PM
Study NCT ID:
NCT06849557
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chair-bound Exergaming in Pre-frail/ Frail Older Adults in Nursing Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088544', 'term': 'Exergaming'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'upper extremity endurance', 'timeFrame': 'T0: baseline', 'description': 'upper extremity endurance measured by arm curl test'}, {'measure': 'upper extremity endurance', 'timeFrame': 'T1: 6 week', 'description': 'upper extremity endurance measured by arm curl test'}, {'measure': 'upper extremity endurance', 'timeFrame': 'T2: immediately (1 week) after intervention', 'description': 'upper extremity endurance measured by arm curl test'}, {'measure': 'enjoyment', 'timeFrame': 'T0: baseline', 'description': 'enjoyment of physical activity measured by Physical Activity Enjoyment Scale (PACES)'}, {'measure': 'enjoyment', 'timeFrame': 'T1: 6 week', 'description': 'enjoyment of physical activity measured by Physical Activity Enjoyment Scale (PACES)'}, {'measure': 'enjoyment', 'timeFrame': 'T2: immediately (1 week) after intervention', 'description': 'enjoyment of physical activity measured by Physical Activity Enjoyment Scale (PACES)'}], 'secondaryOutcomes': [{'measure': 'upper extremity strength', 'timeFrame': 'T0: baseline', 'description': 'upper extremity strength measured by handheld dynamometer'}, {'measure': 'upper extremity strength', 'timeFrame': 'T1: 6 week', 'description': 'upper extremity strength measured by handheld dynamometer'}, {'measure': 'upper extremity strength', 'timeFrame': 'T2: immediately (1 week) after intervention', 'description': 'upper extremity strength measured by handheld dynamometer'}, {'measure': 'lung capacity', 'timeFrame': 'T0: baseline', 'description': 'lung capacity measured by peak flow meter'}, {'measure': 'lung capacity', 'timeFrame': 'T1: 6 week', 'description': 'lung capacity measured by peak flow meter'}, {'measure': 'lung capacity', 'timeFrame': 'T2: immediately (1 week) after intervention', 'description': 'lung capacity measured by peak flow meter'}, {'measure': 'sitting balance', 'timeFrame': 'T0: baseline', 'description': 'sitting balance measured by sitting with opened eyes, sitting with closed eyes, sitting with shaking "no" and sitting with lifted leg'}, {'measure': 'sitting balance', 'timeFrame': 'T1: 6 week', 'description': 'sitting balance measured by sitting with opened eyes, sitting with closed eyes, sitting with shaking "no" and sitting with lifted leg'}, {'measure': 'sitting balance', 'timeFrame': 'T2: immediately (1 week) after intervention', 'description': 'sitting balance measured by sitting with opened eyes, sitting with closed eyes, sitting with shaking "no" and sitting with lifted leg'}, {'measure': 'feasibility, acceptability and appropriateness of intervention', 'timeFrame': 'T2: immediately (1 week) after intervention', 'description': 'feasibility, acceptability and appropriateness of intervention measured by questionnaire'}, {'measure': 'mental health', 'timeFrame': 'T0: baseline', 'description': 'mental health measured by Patient Health Questionnaire-4 (PHQ-4), range: 0-12; higher score indicates more psychological distress'}, {'measure': 'mental health', 'timeFrame': 'T1: 6 week', 'description': 'mental health measured by Patient Health Questionnaire-4 (PHQ-4), range: 0-12; higher score indicates more psychological distress'}, {'measure': 'mental health', 'timeFrame': 'T2: immediately (1 week) after intervention', 'description': 'mental health measured by Patient Health Questionnaire-4 (PHQ-4), range: 0-12; higher score indicates more psychological distress'}, {'measure': 'cognitive function', 'timeFrame': 'T0: baseline', 'description': 'cognitive function measured by Montreal Cognitive Assessment (MoCA), range: 0-30; lower score indicates more cognitive impairment.'}, {'measure': 'cognitive function', 'timeFrame': 'T1: 6 week', 'description': 'cognitive function measured by Montreal Cognitive Assessment (MoCA), range: 0-30; lower score indicates more cognitive impairment.'}, {'measure': 'cognitive function', 'timeFrame': 'T2: immediately (1 week) after intervention', 'description': 'cognitive function measured by Montreal Cognitive Assessment (MoCA), range: 0-30; lower score indicates more cognitive impairment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty in Older Adults']}, 'descriptionModule': {'briefSummary': 'This pilot randomized controlled trial is designed to investigate the effectiveness of chair-bound exergaming on improving physical and cognitive function in pre-frail/ frail nursing home residents', 'detailedDescription': 'Objective To explore the effects of the chair-bound exergaming on the enjoyment of physical activity in in pre-frail/ frail nursing home residents.\n\nTo evaluate the effects of the chair-bound exergaming in improving physical and cognitive function in pre-frail/ frail nursing home residents.\n\nResearch plan and methodology Thirty nursing home residents will be recruited from the nursing homes.\n\nAll the eligible participant will be randomly allocated to either one of the following 2 groups (i) Exergaming (intervention group), or (ii) wait list control.\n\n1. Intervention group (exergaming group, ERG) Those allocated to the ERG will receive supervised chair-bound exercise programme for 12 weeks.\n2. Control group (wait list control, CG) Those allocated to the CG will receive supervised chair-bound exercise programme for 12 weeks after post-assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older adults aged 60 years or older living in the nursing homes;\n* pre-frail or frail according to the Fried Frailty Phenotypes;\n* ability to understand and execute instructions; and\n* ability to sit unassisted on a chair or in a wheelchair.\n\nExclusion Criteria:\n\n* no controlled medical diagnosed of severe cardiometabolic, respiratory and musculoskeletal disorders;\n* any conditions that hinder the participation of intervention and assessment; and\n* being involved in any other clinical trials.'}, 'identificationModule': {'nctId': 'NCT06849557', 'briefTitle': 'Chair-bound Exergaming in Pre-frail/ Frail Older Adults in Nursing Home', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Metropolitan University'}, 'officialTitle': 'Effectiveness of Chair-bound Exergaming on Physical and Cognitive Functions in Pre-frail/ Frail Older Adults in Nursing Home: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HE-SF2024/58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Wait-list Control', 'description': 'Wait list control, after post-test, 12 week supervised exercise intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Exergaming', 'description': '12-week exergaming intervention', 'interventionNames': ['Behavioral: Exergaming']}], 'interventions': [{'name': 'Exergaming', 'type': 'BEHAVIORAL', 'description': 'This intervention will last 12 weeks. Frail/ pre-frail participants will engage in supervised chair-bound exergaming.', 'armGroupLabels': ['Exergaming']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Leung', 'role': 'CONTACT', 'phone': '2367 8918'}], 'facility': 'Hiu Kwong (Tak Yue) Nursing Centre', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Bonny YM Wong', 'role': 'CONTACT', 'email': 'bymwong@hkmu.edu.hk', 'phone': '+852 3970-2976'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}