Exercise to Improve Balance in Older Adults With Hearing Impairment - a Proof-of-concept Study
24 de fevereiro de 2020 atualizado 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.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Antecipado)
60
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
70 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Outro: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Short physical performance battery
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Standing balance - posturography
Prazo: 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
Prazo: 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)
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Activity monitoring
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de maio de 2020
Conclusão Primária (Antecipado)
31 de dezembro de 2021
Conclusão do estudo (Antecipado)
1 de setembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
22 de dezembro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de fevereiro de 2020
Primeira postagem (Real)
25 de fevereiro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de fevereiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de fevereiro de 2020
Última verificação
1 de fevereiro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2019/FO243016
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