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

Primary Purpose

Hearing Loss, Functional

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise + health education+ auditory rehabilitation
auditory rehabilitation alone
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hearing Loss, Functional

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Auditory rehabilitation alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

functional fitness
Gait speed (6 minute walk test: distance in meters walked in 6 minutes)

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2016
Last Updated
November 4, 2020
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02662192
Brief Title
Fitness, Hearing and Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life
Acronym
WTL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Functional

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Exercise + health education + auditory rehabilitation 10 weeks of exercise, interactive health education, socialization and auditory rehabilitation program
Arm Title
Auditory rehabilitation alone
Arm Type
Active Comparator
Arm Description
auditory rehabilitation alone 1 hour of group auditory rehabilitation once a week for 10 weeks
Intervention Type
Other
Intervention Name(s)
Exercise + health education+ auditory rehabilitation
Intervention Description
comparison of 3/4 of an hour balance, resistance and strength training, 1 hour health education, 1 hour auditory rehabilitation
Intervention Type
Other
Intervention Name(s)
auditory rehabilitation alone
Intervention Description
10 weeks of one hour per week of group auditory rehabilitation
Primary Outcome Measure Information:
Title
functional fitness
Description
Gait speed (6 minute walk test: distance in meters walked in 6 minutes)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Psychosocial outcomes
Description
Hearing and health-related quality of life HHIE-25
Time Frame
3 months
Title
Physical and behaviour measures
Description
Physical activity: Time spent in moderate-vigorous physical activity: The Actigraph GT3X+ tri-axial waist worn accelerometer (Actigraph, Pensacola, Florida)
Time Frame
3 months
Title
Project evaluation
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Jones, PhD, MD
Organizational Affiliation
University of British Columbia Okanagan, Kelowna, British Columbia, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Medical Program, University of British Columbia Okanagan, 321 Reichwald Health Sciences Center, 1088 Discovery Ave.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Z-4C6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
30987987
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.
Results Reference
background
PubMed Identifier
28129779
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.
Results Reference
derived

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

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