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

24 de febrero de 2020 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

60

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

70 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otro: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Short physical performance battery
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Standing balance - posturography
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Activity monitoring
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de mayo de 2020

Finalización primaria (Anticipado)

31 de diciembre de 2021

Finalización del estudio (Anticipado)

1 de septiembre de 2022

Fechas de registro del estudio

Enviado por primera vez

22 de diciembre de 2019

Primero enviado que cumplió con los criterios de control de calidad

24 de febrero de 2020

Publicado por primera vez (Actual)

25 de febrero de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de febrero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

24 de febrero de 2020

Última verificación

1 de febrero de 2020

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Virtual reality exercise

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