Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-30 @ 2:52 AM
Study NCT ID:
NCT07071168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing-physical Activity Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011304', 'term': 'Presbycusis'}], 'ancestors': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-08', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': '7 days', 'description': 'Physical activity levels (objectively): A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count. 44 Physical activity levels (subjectively): will be measured using the Chinese version of the 7-item International Physical Activity Questionnaire, which assesses the durations of time in the past 7 days that respondent stayed sedentary or engaged in ambulatory, moderate or vigorous physical activities. It has good psychometrics at the scale- and subscale- levels and significantly correlated with the objective physical activity measures.'}], 'secondaryOutcomes': [{'measure': 'Loneliness', 'timeFrame': '2 weeks', 'description': "Loneliness will be measured using the 6-item De Jong Gierveld Loneliness Scale (Chinese version).47 It consists of two subscales: emotional loneliness and social loneliness. The scale has been validated and recommended as reliable (Cronbach's a=0.76, the intra-class correlation coefficients ranged from 0.98 to 1.00)."}, {'measure': 'Communication', 'timeFrame': '2 weeks', 'description': 'Communication will be measured using Chinese version of the Hearing Handicap Inventory for the elderly (HHIE)48'}, {'measure': 'Depressive symptoms', 'timeFrame': '2 weeks', 'description': 'Depressive symptoms will be measured by PHQ-9, which is a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression'}, {'measure': 'Cognitive function', 'timeFrame': '2 weeks', 'description': 'Cognitive function will be measured by the Hong Kong-Montreal Cognitive Assessment (HK-MoCA).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Age-Related']}, 'descriptionModule': {'briefSummary': 'Background\n\nBy 2050, approximately 2.5 billion people are expected to experience some degree of age-related hearing loss (ARHL). Greater ARHL is associated with decreased communication, reduced physical activity and social engagement, increased depressive symptoms, cognitive decline and a higher risk of dementia. While previous studies highlight the benefits of combing hearing training and physical activity for older adults with ARHL, existing interventions are very limited. Additionally, the development of previous interventions often lacks end-user involvement, resulting in low adherence.\n\nObjectives\n\nThis study aims to co-design a hearing-physical activity dual-task training app with older adults with ARHL, the potential end-users; to assess the feasibility and acceptability of the app using based on the theoretical framework of acceptability; and to examine its preliminary effects on improving physical activity, communication, loneliness, depressive symptoms and cognitive functions for older adults with age-related hearing loss.\n\nHypothesis to be tested\n\nThe app is feasible and acceptable to participants. Upon completing the 10-week intervention, the intervention group will report significantly greater improvements in physical activity, communication, loneliness, depressive symptoms and cognitive functions than the control group. These findings will support subsequent investigations in a larger-scale randomized controlled trial.\n\nResearch Design and Methods\n\nThis study consists of three phases. Phase 1: co-develop a prototype app that combines hearing and physical activity dual-task trainings, incorporating a music therapy component for older adults with ARHL. Co-design workshops will be conducted following the community-based participatory research methodology, where participants will engage in plenary and breakout sessions. Phase 2: conduct a two-arm, single-blinded, pilot randomized controlled trial. Phase 3: conduct individual semi-structured interviews immediately after the intervention. Four process evaluation outcomes will be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. Participants will include Chinese adults aged 60 years or older, with mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears.\n\nMain outcome measures Physical activity levels.\n\nData analysis\n\nDescriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used.\n\nExpected results\n\nA hearing-physical activity dual-task training app prototype, available in both Cantonese and Mandarin, will be co-designed, tested and refined to a final version. Participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The inclusion criteria are: (1) ethnic Chinese aged 60 years and above living at home; (2) with mild to moderate hearing loss diagnosed by a pure-tone average of 20 to 50 dB across octave frequencies 0.5 to 4kHz in both ears; and (3) no cognitive impairment \\[score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)\\].\n\nThe exclusion criteria include: (1) those with a diagnosis of a major neurocognitive disorder; (2) a history of symptomatic stroke or other disease of the central nervous system; 3) a serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or a visual impairment that would interfere with using app.'}, 'identificationModule': {'nctId': 'NCT07071168', 'briefTitle': 'Hearing-physical Activity Intervention', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Developing A Hearing-physical Activity Dual-task Training App for Older Adults With Hearing Loss: A Mixed Method Study', 'orgStudyIdInfo': {'id': 'P0054427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity group', 'description': 'A hearing-physical activity training', 'interventionNames': ['Behavioral: hearing-physical activity training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'waiting list group', 'interventionNames': ['Behavioral: hearing-physical activity training']}], 'interventions': [{'name': 'hearing-physical activity training', 'type': 'BEHAVIORAL', 'description': 'In this study, the intervention was designed to span 10 weeks. Based on our previous study, participants will attend hearing training 30 minutes/day, 5 days/week, The physical activity program will be performed at moderate intensity, 60 min/day, 3 days/week.39', 'armGroupLabels': ['Control group', 'Physical activity group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ivy Zhao', 'role': 'CONTACT', 'email': 'yan-ivy.zhao@polyu.edu.hk', 'phone': '27664550'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'ZHAO Yan Ivy', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}