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

Hearing Loss Clinical Trial

Official title:

Balance and Mobility in Older Adults With Hearing Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04283279
• Other study ID #: 2019/FO243016
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2020
• Source: Western Norway University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Balance; Distorted
• Deafness
• Gait Disorders, Neurologic
• Gait, Unsteady
• Hearing Loss
• Old Age; Debility

Intervention

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.
• 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.
• Control
Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Western Norway University of Applied Sciences	Haukeland University Hospital, University of Dublin, Trinity College

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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	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
Secondary	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
Secondary	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