NCT02662192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

January 14, 2016

Last Update Submit

November 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • functional fitness

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

    3 months

Secondary Outcomes (3)

  • Psychosocial outcomes

    3 months

  • Physical and behaviour measures

    3 months

  • Project evaluation

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Exercise + health education+ auditory rehabilitation

Auditory rehabilitation alone

ACTIVE COMPARATOR

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

Other: auditory rehabilitation alone

Interventions

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

Intervention

10 weeks of one hour per week of group auditory rehabilitation

Auditory rehabilitation alone

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Dementia
  • Depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kelowna, British Columbia, V1Z-4C6, Canada

Location

Related Publications (2)

  • 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: 30987987BACKGROUND
  • 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.

MeSH Terms

Conditions

Hearing Loss, Functional

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Charlotte Jones, PhD, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 25, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 15, 2016

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

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

Locations