Real-life Dual-Task Training for Older Adults at Risk to Fall: A Pilot Clinical Trial (REAL-DTT)
Older adults have difficulty optimizing two tasks at once and typically experience greater interference than younger adults when dual-tasking, meaning that there is greater decline in performance of at least one task when comparing single and dual-tasking. Difficulty dual-tasking may actually predict falls in community-dwelling older adults. Dual-task training has been shown to improve cognitive outcomes (attention, memory), motor outcomes (balance, gait), and dual-task performance in older adults; however, most dual-task training involves simulated tasks that do not reflect functional dual tasks in the real world. Greater dual-task improvements could be seen when training functionally specific tasks. One way to increase task specificity is to offer real-life, contextually-relevant, dual-task training embedded in instrumental activities of daily living (IADLs). Therefore, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a real-life dual-task training program for older adults at risk to fall compared to fall prevention education.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Laura A Swink, PhD
- Número de telefone: 9704917915
- E-mail: laura.swink@colostate.edu
Locais de estudo
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Colorado
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Fort Collins, Colorado, Estados Unidos, 80524
- Colorado State University
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Contato:
- Laura Swink, PhD
- Número de telefone: 9704917915
- E-mail: laura.swink@colostate.edu
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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:
- ≥65 years old
- fall risk identified from one of the Centers for Disease Control STEADI Three Key Questions Screen
- ambulatory in the home with or without an assistive device
- fluent in English
Exclusion Criteria:
- clinically meaningful cognitive impairment as evidenced by Montreal Cognitive Assessment Score screening
- unstable cardiac condition (e.g., unstable angina, acute myocarditis, acute pericarditis)
- acute systemic infection
- active cancer treatment
- prisoners
- unable or unwilling to attend assessment or intervention sessions (Colorado State University)
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: Real-life Dual-Task Training
Six real-life dual-task training sessions with explicit focus on motor and cognitive components of instrumental activities of daily living. Training occurs with a licensed occupational therapist, and activity selection and grading is guided by the therapist and participant. |
The intervention is Real-life Dual-Task Training (Real-DTT) which uses instrumental activities of daily living training with explicit focus on the cognitive and motor elements and progressive complexity. A structured debrief is used to determine when to focus attention on cognitive vs. motor tasks in order to reduce fall risk. The Real-DTT sessions will be delivered once a week for 6 weeks and delivered by a licensed occupational therapist. Real-DTT is a modified version of occupational therapy, with a protocol tailored to the participants. |
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Comparador Ativo: Fall Prevention Education
Six guided fall prevention education sessions combining evidence-based fall prevention topics, CDC patient fall prevention handouts, NIH/NCOA fall prevention education resources, and tailored discussion utilizing behavior-change techniques. |
Guided fall prevention education combining evidence-based fall prevention topics, CDC patient fall prevention handouts, NIH/NCOA fall prevention education resources, and tailored discussion utilizing behavior-change techniques. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cognitive Dual-Task Effect
Prazo: Baseline, week 6-7, week 12-14
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Cognitive Dual-task Effect is a percent change from single to dual-tasking: ([dual-task-singletask]/single-task) *100. The cognitive condition is verbal fluency. The dual-task condition combines verbal fluency (cognitive) through the Timed Up & Go dual task. |
Baseline, week 6-7, week 12-14
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Motor Dual-Task Effect
Prazo: Baseline, week 6-7, week 12-14
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Motor Dual-task Effect is calculated as a motor percent changes from single to dual-tasking: ([dual-task-singletask]/single-task) *100. The percent change calculates the difference in time in seconds to complete the Timed Up & Go from single to dual-task. |
Baseline, week 6-7, week 12-14
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Performance-Based Assessment of Self-Care Skills
Prazo: Baseline, week 6-7, week 12-14
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The Performance-Based Assessment of Self-Care Skills (PASS) is a performance-based measure of activity performance. The PASS is validated for individual instrumental activities of daily living (IADLs) and therefore we will use the 14 physical emphasis IADLs, and the 4 cognitive emphasis IADLs. |
Baseline, week 6-7, week 12-14
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Activities-Specific Balance Confidence Scale
Prazo: Baseline, week 6-7, week 12-14
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A standardized 16-item self-report measure of balance confidence, scores range from 0-100% with higher scores indicating greater confidence in balance when performing various functional activities. |
Baseline, week 6-7, week 12-14
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Acceptability of Intervention Measure
Prazo: week 12-14
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The Acceptability of Intervention Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater acceptability. |
week 12-14
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Intervention Appropriateness Measure
Prazo: week 12-14
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The Intervention Appropriateness Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater appropriateness. |
week 12-14
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Feasibility of Intervention Measure
Prazo: week 12-14
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The Feasibility of Intervention Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater feasibility. |
week 12-14
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 8483
- R21AG095443 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
At the study completion, de-identified (i.e., not including name, or any identifying information) demographic data, health information data, self-reported falls data, and performance-based assessment data will be preserved to enable sharing on a repository for transparency and per NIH sharing agreements.
Prazo de Compartilhamento de IPD
Reviewed by NACDA after study completion, data de-identification, and posting. Then NACDA maintains archives permanently.
Critérios de acesso de compartilhamento IPD
NACDA's curation staff performs a reidentification risk and harm risk review of all data to ensure confidentiality is protected in released datasets. Data cleared for public access have minimal reidentification and harm risk, and therefore, no restrictions on access.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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