Clinical trial NCT02662192: Fitness, Hearing and Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life
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
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Functional
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: functional fitness
timeFrame: 3 months
Secondary outcomes:
measure: Psychosocial outcomes
timeFrame: 3 months
measure: Physical and behaviour measures
timeFrame: 3 months
measure: Project evaluation
timeFrame: 3 months
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Southern Medical Program, University of British Columbia Okanagan, 321 Reichwald Health Sciences Center, 1088 Discovery Ave.
state: British Columbia
Study officials:
affiliation: University of British Columbia Okanagan, Kelowna, British Columbia, Canada
name: Charlotte Jones, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.