- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01910740
Mobility in Older People (MOVE)
Optimising Rehabilitation Outcomes in Frail Older Adults: Effects of Increasing the Amount of Physical Activity
The main aim of this study is to investigate whether increasing the amount of physical activity in frail older people during hospital based rehabilitation is associated with better mobility outcomes compared to usual care. A second aim is to investigate whether this physical activity intervention is associated with improvements in health related quality of life. Finally we plan to investigate whether increasing the amount of physical activity during rehabilitation is cost effective, measured from a health system perspective, compared with usual care.
Older people receiving inpatient rehabilitation will be randomly assigned to an intervention group, who will receive extra physical activity on weekdays and weekends or a control group, who will receive additional activities based on social interaction. The activity sessions will be individualized to the particular participant. Both groups of people will be assessed at baseline, discharge from hospital and at 6 months following discharge. The intervention group will be provided with one or two extra sessions on weekdays and two extra sessions on weekends for the duration of their rehabilitation stay. To account for the extra physiotherapy time that the intervention group receives, the people in the control group will spend the same amount of time performing other activities, such as cards, board games or reading, whilst seated. To ensure the safety of the participants in this study, each physical activity session will be supervised by either a physiotherapist or allied health assistant.
Hypothesis 1: The primary hypothesis is that, compared with usual care, increasing the amount of physical activity in frail older people during rehabilitation will lead to more optimal mobility at discharge, as measured by gait speed.
Secondary hypotheses are that, compared with usual care, increasing the amount of physical activity during rehabilitation will:
Hypothesis 2: lead to significantly greater improvements in mobility and function both at discharge and six months following discharge.
Hypothesis 3: lead to better quality of life six months following hospital discharge, measured using the EuroQol Health (EQ5D) Questionnaire and the EuroQol-Visual Analogue Scale (EQ-VAS).
Hypothesis 4: be cost effective compared to usual care
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Victoria
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Heidelberg, Victoria, Austrália, 3084
- Heidelberg Repatriation Hospital, Austin Health
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- over 60 years of age
- a goal of admission is to 'improve weight-bearing mobility or improve walking' as determined by either the admission referral or the treating therapist
Exclusion Criteria:
- specific medical restrictions that limit mobilisation (e.g. non weight bearing)
- if already enrolled in a different Randomised Controlled Trial
- previously enrolled in the current trial
- the primary reason for admission is awaiting a residential care placement
- the primary reason for admission is for carer training
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Enhanced Physical Activity
Participants in the Enhanced Physical Activity group will receive a program of enhanced physical activity in addition to the usual care.
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Individually tailored programs focused on increasing the amount of time participants spend performing mobility activities, particularly standing and walking in the late afternoons and evenings and on weekends.
These participants will be provided with one or two extra sessions on weekdays and two extra sessions on weekend days for the duration of their rehabilitation stay.
Therapy provided by a multidisciplinary team which includes physiotherapy and occupational therapy on weekdays with other allied health input (eg speech pathology, social work) as indicated.
Medical and nursing care is also provided seven days a week.
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Comparador Ativo: Usual Care
The Usual Care group will receive usual therapy provided by a multidisciplinary team and social interaction.
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Therapy provided by a multidisciplinary team which includes physiotherapy and occupational therapy on weekdays with other allied health input (eg speech pathology, social work) as indicated.
Medical and nursing care is also provided seven days a week.
To control for the extra hours of physical activity that the experimental group receives, participants in the control group shall have additional activities such as card and board games, conversation or reading as well as upper limb exercises and other physical activities that have minimal impact on ambulant mobility.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Gait Velocity
Prazo: Discharge (Average Duration of Hospital Stay is 3 weeks)
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Gait velocity will be measured using the 6 metre walk test
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Discharge (Average Duration of Hospital Stay is 3 weeks)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Gait Velocity
Prazo: 6 Months Follow Up (post discharge)
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Gait velocity will be measured using the 6 metre walk test
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6 Months Follow Up (post discharge)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Meg Morris, PhD, La Trobe University
Publicações e links úteis
Publicações Gerais
- Said CM, McGinley JL, Szoeke C, Workman B, Hill KD, Wittwer JE, Woodward M, Liew D, Churilov L, Bernhardt J, Morris ME. Factors associated with improved walking in older people during hospital rehabilitation: secondary analysis of a randomized controlled trial. BMC Geriatr. 2021 Jan 31;21(1):90. doi: 10.1186/s12877-021-02016-0.
- Said CM, Morris ME, McGinley JL, Szoeke C, Workman B, Liew D, Hill K, Woodward M, Wittwer JE, Churilov L, Ventura C, Bernhardt J. Evaluating the effects of increasing physical activity to optimize rehabilitation outcomes in hospitalized older adults (MOVE Trial): study protocol for a randomized controlled trial. Trials. 2015 Jan 15;16:13. doi: 10.1186/s13063-014-0531-y.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- NHMRC - 1042680
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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