Hearing Loss, FunctionalWTLNCT02662192
Fitness, Hearing and Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life
A study testing Exercise + health education+ auditory rehabilitation and auditory rehabilitation alone in people with Hearing Loss, Functional, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Functional
- What is being tested?
- Exercise + health education+ auditory rehabilitation and auditory rehabilitation alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- -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)
Show all 11Show fewer
- 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
Who cannot join
- Dementia
- Depression
Trial locations and contacts
1 site in 1 country.
Canada1 site
Southern Medical Program, University of British Columbia Okanagan, 321 Reichwald Health Sciences Center, 1088 Discovery Ave.
Kelowna, British Columbia, V1Z-4C6
About this study
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
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.
Read the 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.
- Conditions
- Hearing Loss, Functional
- Being tested
- Exercise + health education+ auditory rehabilitation, auditory rehabilitation alone
- Medical subject headings
- Hearing Loss, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + health education+ auditory rehabilitationOther
comparison of 3/4 of an hour balance, resistance and strength training, 1 hour health education, 1 hour auditory rehabilitation
auditory rehabilitation aloneOther
10 weeks of one hour per week of group auditory rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Exercise + health education + auditory rehabilitation 10 weeks of exercise, interactive health education, socialization and auditory rehabilitation program Receives: 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 Receives: Other: auditory rehabilitation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional fitness
Gait speed (6 minute walk test: distance in meters walked in 6 minutes)
Measured: 3 months
Secondary outcomes (3)
Psychosocial outcomes
Hearing and health-related quality of life HHIE-25
Measured: 3 months
Physical and behaviour measures
Physical activity: Time spent in moderate-vigorous physical activity: The Actigraph GT3X+ tri-axial waist worn accelerometer (Actigraph, Pensacola, Florida)
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion1 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, FunctionalStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Jones, University of British Columbia
- Investigators
- Charlotte Jones, PhD, MD, Principal investigator, University of British Columbia Okanagan, Kelowna, British Columbia, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662192
- Sponsor's protocol ID
- H15-02319
- Acronym
- WTL
- Status last verified
- Nov 2020
- First submitted
- 14 Jan 2016
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only aggregate data will be shared. Consent form indicates this as well, so participants understand that their individual data will not be shared
Publications
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.
PubMed 30987987Lambert 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.
PubMed 28129779
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02662192
- Acronym / sponsor ID
- WTL / H15-02319
- Conditions
- Hearing Loss, Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise + health education+ auditory rehabilitationExercise + health education + auditory rehabilitation 10 weeks of exercise, interactive health education, socialization and auditory rehabilitation program |
| Auditory rehabilitation alone | Active comparator | Other: auditory rehabilitation aloneauditory rehabilitation alone 1 hour of group auditory rehabilitation once a week for 10 weeks |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- -Gender: Male and female
- 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)
Key exclusion criteria (2 listed)
- Dementia
- Depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise + health education+ auditory rehabilitationcomparison of 3/4 of an hour balance, resistance and strength training, 1 hour health education, 1 hour auditory rehabilitation | Other | Intervention |
| auditory rehabilitation alone10 weeks of one hour per week of group auditory rehabilitation | Other | Auditory rehabilitation alone |
Primary outcome
functional fitness
Time frame: 3 months
Gait speed (6 minute walk test: distance in meters walked in 6 minutes)
3 secondary outcomes
Psychosocial outcomes
Time frame: 3 months
Physical and behaviour measures
Time frame: 3 months
Project evaluation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Background: PubMed 30987987Jones 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.
- Derived from this study: PubMed 28129779Lambert 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.
- Individual participant dataSharing planned: No. Only aggregate data will be shared. Consent form indicates this as well, so participants understand that their individual data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Jones, PhD, MD principal investigator
University of British Columbia Okanagan, Kelowna, British Columbia, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + health education+ auditory rehabilitation and auditory rehabilitation alone in people with Hearing Loss, Functional, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional fitness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662192, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.