Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
24. Februar 2020 aktualisiert von: Bård Bogen, Western Norway University of Applied Sciences
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.
Studienübersicht
Status
Unbekannt
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
60
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
70 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Virtual reality exercise
20 participants will be randomised to this arm
|
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
|
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.
|
|
Sonstiges: Control
20 participants will be randomised to this arm
|
Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Short physical performance battery
Zeitfenster: 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.
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Standing balance - posturography
Zeitfenster: 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
|
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
Zeitfenster: 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
|
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)
Zeitfenster: 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
|
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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Activity monitoring
Zeitfenster: 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
|
Measured as change from baseline/before intervention to after intervention (6 weeks after baseline)
|
|
Dizziness Handicap Inventory
Zeitfenster: 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.
|
Measured at baseline/before intervention and after intervention (6 weeks after baseline)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. Mai 2020
Primärer Abschluss (Voraussichtlich)
31. Dezember 2021
Studienabschluss (Voraussichtlich)
1. September 2022
Studienanmeldedaten
Zuerst eingereicht
22. Dezember 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Februar 2020
Zuerst gepostet (Tatsächlich)
25. Februar 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. Februar 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Februar 2020
Zuletzt verifiziert
1. Februar 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2019/FO243016
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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