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

November 4, 2020 updated by: Charlotte Jones, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Z-4C6
        • Southern Medical Program, University of British Columbia Okanagan, 321 Reichwald Health Sciences Center, 1088 Discovery Ave.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Exercise + health education + auditory rehabilitation 10 weeks of exercise, interactive health education, socialization and auditory rehabilitation program
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
Active Comparator: Auditory rehabilitation alone

auditory rehabilitation alone

1 hour of group auditory rehabilitation once a week for 10 weeks
Other: auditory rehabilitation alone
10 weeks of one hour per week of group auditory rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional fitness
Time Frame: 3 months
Gait speed (6 minute walk test: distance in meters walked in 6 minutes)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial outcomes
Time Frame: 3 months
Hearing and health-related quality of life HHIE-25
3 months
Physical and behaviour measures
Time Frame: 3 months
Physical activity: Time spent in moderate-vigorous physical activity: The Actigraph GT3X+ tri-axial waist worn accelerometer (Actigraph, Pensacola, Florida)
3 months
Project evaluation
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Charlotte Jones, PhD, MD, University of British Columbia Okanagan, Kelowna, British Columbia, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 15, 2016

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H15-02319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only aggregate data will be shared. Consent form indicates this as well, so participants understand that their individual data will not be shared

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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