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

NCT ID: NCT04283279

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual reality exercise

20 participants will be randomised to this arm

Group Type: EXPERIMENTAL

Virtual reality exercise

Intervention Type: OTHER

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

20 participants will be randomised to this arm

Group Type: EXPERIMENTAL

Vestibular rehabilitation exercise

Intervention Type: OTHER

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

20 participants will be randomised to this arm

Group Type: OTHER

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Bård Bogen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2019/FO243016

Identifier Type: -

Identifier Source: org_study_id