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

Sponsor
Western Norway University of Applied Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04283279
Collaborator
Haukeland University Hospital (Other), University of Dublin, Trinity College (Other)
60
3
28

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality exercise
  • Other: Vestibular rehabilitation exercise
  • Other: Control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Balance and Mobility in Older Adults With Hearing Impairment
Anticipated Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Short physical performance battery [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]

    Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.

Secondary Outcome Measures

  1. Standing balance - posturography [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]

    Body sway measured on a balance platform, with eyes open/closed and on a firm/compliant surface

  2. Walking balance [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]

    Participants will walk across an electronic walkway that registers steps, for analysis of gait steadiness

  3. The World Health Organisation Disability Assessment Schedule (WHODAS) [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]

    Questionnaire that registers disability across several domains. Possible score range is 0-144, where lower values indicate less disability

Other Outcome Measures

  1. Activity monitoring [Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)]

    Participants will wear sensors over 4 days, registering activity in their own environments

  2. Dizziness Handicap Inventory [Measured at baseline/before intervention and after intervention (6 weeks after baseline)]

    25 item-questionnaire that registers limitations due to dizziness. Possible scores range from 0-100, and higher scores indicate more dizziness-related handicap.

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Western Norway University of Applied Sciences
  • Haukeland University Hospital
  • University of Dublin, Trinity College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bård Bogen, Associate professor, Western Norway University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT04283279
Other Study ID Numbers:
  • 2019/FO243016
First Posted:
Feb 25, 2020
Last Update Posted:
Feb 25, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2020