Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
Balance and Mobility in Older Adults With Hearing Impairment
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Hearing impairment is common in older adults, and recent research points to associations between hearing impairment and balance/mobility. The association may be due to more attentional resources being used to compensate for the sensory loss, with less resources available for maintaining balance. The aim of this projects is therefore to investigate whether an exercise program with focus on motor-cognitive tasks is feasible for older adults with hearing impairment. The study is meant as a proof-of-concept study, where trialling will be evaluated, and results will be used to inform the design of a larger and adequately powered study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2019
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedFebruary 25, 2020
February 1, 2020
1.7 years
December 22, 2019
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Short physical performance battery
Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.
Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
Secondary Outcomes (3)
Standing balance - posturography
Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
Walking balance
Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
The World Health Organisation Disability Assessment Schedule (WHODAS)
Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention
Other Outcomes (2)
Activity monitoring
Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
Dizziness Handicap Inventory
Measured at baseline/before intervention and after intervention (6 weeks after baseline)
Study Arms (3)
Virtual reality exercise
EXPERIMENTAL20 participants will be randomised to this arm
Vestibular rehabilitation exercise
EXPERIMENTAL20 participants will be randomised to this arm
Control
OTHER20 participants will be randomised to this arm
Interventions
Participants will do exercises in a virtual environment, solving tasks that require cognitive efforts and motor/balance efforts. The virtual environment/tasks will be delivered through a head-mounted display ("goggles"). Difficulty will progress from standing/sitting, to walking on a treadmill. The environments that will be used will be both over-the-counter environments, as well as in-house designed environments.
Vestibular rehabilitation exercises focus on head and eyes movements, as well as whole-body movements. The aim is to facilitate the use of other sensory organs than the vestibular organs, which will also be relevant to persons who are not receiving sufficient sensory information from the auditory system. The exercises will progress as tolerated, under careful supervision of trained therapists.
Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active
Eligibility Criteria
You may qualify if:
- Hearing threshold above 30 dB
You may not qualify if:
- Inability to give informed consent,
- Inability to speak Scandinavian languages or English
- Diseases with severe motor impairments (such as mb Parkinsons)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Western Norway University of Applied Scienceslead
- Haukeland University Hospitalcollaborator
- University of Dublin, Trinity Collegecollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
December 22, 2019
First Posted
February 25, 2020
Study Start
May 1, 2020
Primary Completion
December 31, 2021
Study Completion
September 1, 2022
Last Updated
February 25, 2020
Record last verified: 2020-02