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

Balance and Mobility in Older Adults With Hearing Impairment

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.

Study Overview

• Status: Unknown
• Conditions: Hearing Loss; Old Age; Debility; Gait, Unsteady; Balance; Distorted
• Intervention / Treatment: Other: Virtual reality exercise; Other: Vestibular rehabilitation exercise; Other: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity monitoring	Participants will wear sensors over 4 days, registering activity in their own environments	Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
Dizziness Handicap Inventory	25 item-questionnaire that registers limitations due to dizziness. Possible scores range from 0-100, and higher scores indicate more dizziness-related handicap.	Measured at baseline/before intervention and after intervention (6 weeks after baseline)

Collaborators and Investigators

• Sponsor: Western Norway University of Applied Sciences
• Collaborators: Haukeland University Hospital; University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Frailty; Hearing Loss; Deafness; Gait Disorders, Neurologic
• Other Study ID Numbers: 2019/FO243016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No