Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study

Study Overview
=================
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.

Official Title
-----------------
Balance and Mobility in Older Adults With Hearing Impairment

Conditions
-----------------
Hearing Loss, Gait, Unsteady, Balance; Distorted, Old Age; Debility

Intervention / Treatment
-----------------
* Other: Virtual reality exercise
* Other: Vestibular rehabilitation exercise
* Other: Control


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality exercise<br>20 participants will be randomised to this arm | Other: Virtual reality exercise<br>* 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.<br>|
| Experimental: Vestibular rehabilitation exercise<br>20 participants will be randomised to this arm | Other: Vestibular rehabilitation exercise<br>* 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.<br>|
| Other: Control<br>20 participants will be randomised to this arm | Other: Control<br>* Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standing balance - posturography | Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface | 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 | Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness | 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) | Questionnaire that registers disability across several domains. Possible score range is 0-144, where lower values indicate less disability | 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 |