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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02662192
Other study ID # H15-02319
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date December 15, 2016

Study information

Verified date November 2020
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. After 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. At 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 15, 2016
Est. primary completion date December 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion criteria: -Gender: Male and female Age limits: - Minimum age: 65 years of age - Maximum age: 90 years of age. - Self-reported diagnosis of hearing loss - Must be independently ambulatory (no use of cane, walker or wheelchair) - Less than150 minutes per week of self-reported physical activity - Healthy enough to participate in the intervention without exacerbating any existing symptomatology - Not having participated in any organized exercise program for at least 6 months - 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 - A Hearing Handicap In the Elderly-25 questionnaire score of 25 > 17 Exclusion Criteria: - Dementia - Depression

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise + health education+ auditory rehabilitation
comparison of 3/4 of an hour balance, resistance and strength training, 1 hour health education, 1 hour auditory rehabilitation
auditory rehabilitation alone
10 weeks of one hour per week of group auditory rehabilitation

Locations

Country Name City State
Canada Southern Medical Program, University of British Columbia Okanagan, 321 Reichwald Health Sciences Center, 1088 Discovery Ave. Kelowna British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary functional fitness Gait speed (6 minute walk test: distance in meters walked in 6 minutes) 3 months
Secondary Psychosocial outcomes Hearing and health-related quality of life HHIE-25 3 months
Secondary Physical and behaviour measures Physical activity: Time spent in moderate-vigorous physical activity: The Actigraph GT3X+ tri-axial waist worn accelerometer (Actigraph, Pensacola, Florida) 3 months
Secondary Project evaluation 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. 3 months
See also
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Withdrawn NCT03511417 - The Effectiveness of Over the Counter Hearing Products for Middle-Aged Adults N/A
Active, not recruiting NCT06176625 - Sight and Hearing Investigation Into Effects on Delirium N/A