Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-01 @ 4:56 PM
Study NCT ID:
NCT02662192
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2016-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fitness, Hearing and Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006315', 'term': 'Hearing Loss, Functional'}], 'ancestors': [{'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'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-13', 'size': 179963, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-10-03T06:14', 'hasProtocol': False}, {'date': '2015-10-08', 'size': 169055, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-04T13:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2016-01-14', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional fitness', 'timeFrame': '3 months', 'description': 'Gait speed (6 minute walk test: distance in meters walked in 6 minutes)'}], 'secondaryOutcomes': [{'measure': 'Psychosocial outcomes', 'timeFrame': '3 months', 'description': 'Hearing and health-related quality of life HHIE-25'}, {'measure': 'Physical and behaviour measures', 'timeFrame': '3 months', 'description': 'Physical activity: Time spent in moderate-vigorous physical activity: The Actigraph GT3X+ tri-axial waist worn accelerometer (Actigraph, Pensacola, Florida)'}, {'measure': 'Project evaluation', 'timeFrame': '3 months', 'description': 'Satisfaction with the Auditory Rehabilitation, health education and exercise sessions. Confidence in being able to maintain their newly acquired communication strategies and exercise regime. Comments on how the program could be improved.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Functional']}, 'referencesModule': {'references': [{'pmid': '30987987', 'type': 'BACKGROUND', 'citation': 'Jones CA, Siever J, Knuff K, Van Bergen C, Mick P, Little J, Jones G, Murphy MA, Kurtz D, Miller H. Walk, Talk and Listen: a pilot randomised controlled trial targeting functional fitness and loneliness in older adults with hearing loss. BMJ Open. 2019 Apr 14;9(4):e026169. doi: 10.1136/bmjopen-2018-026169.'}, {'pmid': '28129779', 'type': 'DERIVED', 'citation': "Lambert J, Ghadry-Tavi R, Knuff K, Jutras M, Siever J, Mick P, Roque C, Jones G, Little J, Miller H, Van Bergen C, Kurtz D, Murphy MA, Jones CA. Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial. Trials. 2017 Jan 28;18(1):47. doi: 10.1186/s13063-017-1792-z."}]}, 'descriptionModule': {'briefSummary': 'This study examines the effect of an exercise and health education/auditory rehabilitation and socialization intervention on functional fitness, hearing handicap and psychosocial distress measures in older adults with hearing loss.', 'detailedDescription': 'Hearing loss is associated with functional fitness declines and increased risk for isolation, dementia, depression, falls, hospitalization and premature mortality. No studies have determined the effect of an exercise intervention on these measures in older adults with hearing loss.\n\nAfter baseline assessment of function fitness and several psychosocial measures, 60 older adults with hearing loss will be randomized into a 10 week exercise, health education, socialization and auditory rehabilitation program or auditory rehabilitation alone. The exercise program consists of 3/4 of an hour strengthening and resistance training followed by 30 minutes of group walking. The educational session content is determined by participants and is interactive and may include such topics as wills and probate, diabetes treatment, healthy exercise etc. The 3/4 of an hour auditory rehabilitation sessions are modified from an online program and will include interactive sessions on education about hearing and hearing devices/technologies, psychosocial support and enhancing communication skills.\n\nAt the end of the 10 week intervention the assessments of functional fitness and psychosocial measures will be repeated. The group that was randomized to the auditory rehabilitation alone will then be offered the exercise program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n-Gender: Male and female\n\nAge limits:\n\n* Minimum age: 65 years of age\n* Maximum age: 90 years of age.\n* Self-reported diagnosis of hearing loss\n* Must be independently ambulatory (no use of cane, walker or wheelchair)\n* Less than150 minutes per week of self-reported physical activity\n* Healthy enough to participate in the intervention without exacerbating any existing symptomatology\n* Not having participated in any organized exercise program for at least 6 months\n* Availability and willingness to attend at least 80% of the 10 week intervention sessions in addition to baseline and final assessments. -Be English speaking and able to sign written informed consent\n* A Hearing Handicap In the Elderly-25 questionnaire score of 25 \\> 17\n\nExclusion Criteria:\n\n* Dementia\n* Depression'}, 'identificationModule': {'nctId': 'NCT02662192', 'acronym': 'WTL', 'briefTitle': 'Fitness, Hearing and Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Targeting Functional Fitness, Hearing and Health-Related Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life, A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H15-02319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Exercise + health education + auditory rehabilitation 10 weeks of exercise, interactive health education, socialization and auditory rehabilitation program', 'interventionNames': ['Other: Exercise + health education+ auditory rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Auditory rehabilitation alone', 'description': 'auditory rehabilitation alone\n\n1 hour of group auditory rehabilitation once a week for 10 weeks', 'interventionNames': ['Other: auditory rehabilitation alone']}], 'interventions': [{'name': 'Exercise + health education+ auditory rehabilitation', 'type': 'OTHER', 'description': 'comparison of 3/4 of an hour balance, resistance and strength training, 1 hour health education, 1 hour auditory rehabilitation', 'armGroupLabels': ['Intervention']}, {'name': 'auditory rehabilitation alone', 'type': 'OTHER', 'description': '10 weeks of one hour per week of group auditory rehabilitation', 'armGroupLabels': ['Auditory rehabilitation alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1Z-4C6', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Southern Medical Program, University of British Columbia Okanagan, 321 Reichwald Health Sciences Center, 1088 Discovery Ave.', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}], 'overallOfficials': [{'name': 'Charlotte Jones, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia Okanagan, Kelowna, British Columbia, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only aggregate data will be shared. Consent form indicates this as well, so participants understand that their individual data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Charlotte Jones', 'investigatorAffiliation': 'University of British Columbia'}}}}