Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
Primary Purpose
Hearing Loss, Gait, Unsteady, Balance; Distorted
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual reality exercise
Vestibular rehabilitation exercise
Control
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Hearing threshold above 30 dB
Exclusion Criteria:
- Inability to give informed consent,
- Inability to speak Scandinavian languages or English
- Diseases with severe motor impairments (such as mb Parkinsons)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Virtual reality exercise
Vestibular rehabilitation exercise
Control
Arm Description
20 participants will be randomised to this arm
20 participants will be randomised to this arm
20 participants will be randomised to this arm
Outcomes
Primary Outcome Measures
Short physical performance battery
Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.
Secondary Outcome Measures
Standing balance - posturography
Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface
Walking balance
Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness
The World Health Organisation Disability Assessment Schedule (WHODAS)
Questionnaire that registers disability across several domains. Possible score range is 0-144, where lower values indicate less disability
Full Information
NCT ID
NCT04283279
First Posted
December 22, 2019
Last Updated
February 24, 2020
Sponsor
Western Norway University of Applied Sciences
Collaborators
Haukeland University Hospital, University of Dublin, Trinity College
1. Study Identification
Unique Protocol Identification Number
NCT04283279
Brief Title
Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
Official Title
Balance and Mobility in Older Adults With Hearing Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Norway University of Applied Sciences
Collaborators
Haukeland University Hospital, University of Dublin, Trinity College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Study design:
This is an experimental (exercise) study with follow-ups three and twelve months after exercise completion.
Participants:
Participants will be recruited from two instances:
"Praksisnett", which is a collaboration between GPs and researchers in Bergen, Norway, where GPs recruit potential participants to research projects.
The Ear, Nose, Throat department at Haukeland University Hospital (Bergen), who provide service to older adults with hearing impairment. The aim is to include 60 patients into three intervention arms: i) virtual reality exercises, ii) vestibular rehabilitation exercises and usual care
Intervention arms:
Virtual reality exercises: Participants will exercise in virtual environments twice weekly. The choice of environments/tasks will be individualized, and progress from sitting/standing exercises, to doing exercises while walking on a treadmill. The aim is to perform cognitive and motor tasks simultanously.
Vestibular rehabilitation exercises: This is an exercise approach that has been used in clinical groups, such as patients with vestibular disorders and traumatic brain injury. The aim is to perform movements/exercises where the participant is exposed gradually to movements that may be provocative for the vestibular system.
The exercises will be done in a movement lab at Western Norway University of Applied Sciences. Participants will be randomised to either of the three intervention arms using a computerized procedure. Neither participants, testers or deliverers of the intervention will be blinded. Testers and intervention deliverers will be physiotherapists, students enrolled in a master program in clinical physiotherapy and bachelor students in physiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Gait, Unsteady, Balance; Distorted, Old Age; Debility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality exercise
Arm Type
Experimental
Arm Description
20 participants will be randomised to this arm
Arm Title
Vestibular rehabilitation exercise
Arm Type
Experimental
Arm Description
20 participants will be randomised to this arm
Arm Title
Control
Arm Type
Other
Arm Description
20 participants will be randomised to this arm
Intervention Type
Other
Intervention Name(s)
Virtual reality exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vestibular rehabilitation exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active
Primary Outcome Measure Information:
Title
Short physical performance battery
Description
Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.
Time Frame
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 Outcome Measure Information:
Title
Standing balance - posturography
Description
Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface
Time Frame
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
Title
Walking balance
Description
Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness
Time Frame
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
Title
The World Health Organisation Disability Assessment Schedule (WHODAS)
Description
Questionnaire that registers disability across several domains. Possible score range is 0-144, where lower values indicate less disability
Time Frame
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 Pre-specified Outcome Measures:
Title
Activity monitoring
Description
Participants will wear sensors over 4 days, registering activity in their own environments
Time Frame
Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
Title
Dizziness Handicap Inventory
Description
25 item-questionnaire that registers limitations due to dizziness. Possible scores range from 0-100, and higher scores indicate more dizziness-related handicap.
Time Frame
Measured at baseline/before intervention and after intervention (6 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hearing threshold above 30 dB
Exclusion Criteria:
Inability to give informed consent,
Inability to speak Scandinavian languages or English
Diseases with severe motor impairments (such as mb Parkinsons)
12. IPD Sharing Statement
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Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
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