Fitness, Hearing and Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life

NCT ID: NCT02662192

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hearing Loss, Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Exercise + health education + auditory rehabilitation 10 weeks of exercise, interactive health education, socialization and auditory rehabilitation program

Group Type EXPERIMENTAL

Exercise + health education+ auditory rehabilitation

Intervention Type OTHER

comparison of 3/4 of an hour balance, resistance and strength training, 1 hour health education, 1 hour auditory rehabilitation

Auditory rehabilitation alone

auditory rehabilitation alone

1 hour of group auditory rehabilitation once a week for 10 weeks

Group Type ACTIVE_COMPARATOR

auditory rehabilitation alone

Intervention Type OTHER

10 weeks of one hour per week of group auditory rehabilitation

Interventions

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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

Intervention Type OTHER

auditory rehabilitation alone

10 weeks of one hour per week of group auditory rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Jones

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlotte Jones, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia Okanagan, Kelowna, British Columbia, Canada

Locations

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Southern Medical Program, University of British Columbia Okanagan, 321 Reichwald Health Sciences Center, 1088 Discovery Ave.

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 30987987 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28129779 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H15-02319

Identifier Type: -

Identifier Source: org_study_id