Clinical trial NCT04283279: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Gait, Unsteady
Balance; Distorted
Old Age; Debility
Lead sponsor: Western Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: University of Dublin, Trinity College
First posted: 2020-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Short physical performance battery
timeFrame: 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:
measure: Standing balance - posturography
timeFrame: 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
measure: Walking balance
timeFrame: 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
measure: The World Health Organisation Disability Assessment Schedule (WHODAS)
timeFrame: 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:
measure: Activity monitoring
timeFrame: Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
measure: Dizziness Handicap Inventory
timeFrame: Measured at baseline/before intervention and after intervention (6 weeks after baseline)
Locations:
Study officials:
References: