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Wearable-Assisted Walking for Cognitive Function and Loneliness in Older Adults (WAW-CogLon)

10 de junho de 2026 atualizado por: CHENG-EN WU, National Taiwan College of Performing Arts

Effects of a Wearable-Assisted Walking Program on Longitudinal Trajectories of Cognitive Function and Loneliness in Older Adults: A Randomized Controlled Trial

Participants in the wearable-assisted walking group were asked to walk five days per week for approximately 30 minutes per session at moderate intensity. An Apple Watch was used to monitor daily steps, walking duration, and estimated energy expenditure. Participants also received weekly feedback to support adherence to the walking program. Participants in the usual-care control group were asked to maintain their usual daily activities and not begin any new structured exercise program during the study period.

Cognitive function was measured using the Montreal Cognitive Assessment, and loneliness was measured using the 8-item UCLA Loneliness Scale. Assessments were conducted at baseline and at weeks 4, 8, and 12. The study also explored whether baseline muscle mass and functional mobility were associated with changes in cognitive function and loneliness over time.

Visão geral do estudo

Descrição detalhada

This randomized controlled trial examined longitudinal changes in cognitive function and loneliness during a 12-week wearable-assisted walking intervention. The intervention combined regular moderate-intensity walking with wearable-device monitoring and weekly feedback. The control group received usual care and maintained their normal daily activities.

The primary outcome was cognitive function, measured using the Montreal Cognitive Assessment. The secondary psychosocial outcome was loneliness, measured using the 8-item UCLA Loneliness Scale. Outcomes were assessed at four time points: baseline, week 4, week 8, and week 12. Baseline appendicular skeletal muscle mass index and timed up-and-go performance were also assessed to examine whether muscle health and functional mobility were associated with individual differences in outcome trajectories.

Tipo de estudo

Intervencional

Inscrição (Real)

120

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • New Taipei City, Taiwan, 251301
        • National Taiwan College of Performing Arts

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

  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

Age 65 years or older. Community-dwelling older adults recruited from community-based older adult programs in Taiwan.

Ability to walk independently or with minimal assistance. Willingness to be randomized to either the wearable-assisted walking group or the usual-care control group.

Willingness to wear a wearable device if assigned to the intervention group. Ability to understand the study procedures and complete the cognitive, psychological, and physical assessments.

Provision of written informed consent before enrollment and baseline assessment.

Exclusion Criteria:

Severe cardiovascular disease. Recent fracture or surgery. Severe neurological disorders. Severe cognitive impairment that precluded completion of study assessments. Medical contraindications to moderate-intensity walking. Current enrollment in other structured exercise or rehabilitation programs during the study period.

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: Wearable-Assisted Walking Group
Participants assigned to this group received a 12-week wearable-assisted walking intervention. They were instructed to walk five days per week, with each session lasting approximately 30 minutes at moderate intensity. A commercially available Apple Watch was used to monitor daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence.
The intervention consisted of a 12-week moderate-intensity walking program supported by a commercially available wearable device. Participants were instructed to walk five days per week for approximately 30 minutes per session. Walking intensity was guided by a rating of perceived exertion of 11-13. An Apple Watch was used to record daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence.
Sem intervenção: Usual-Care Control Group
Participants assigned to this group were instructed to maintain their routine daily activities and typical lifestyle throughout the 12-week study period. They were asked not to initiate any new structured exercise or rehabilitation program during the study period. They did not receive wearable devices, structured walking prescriptions, or weekly activity feedback.
Experimental: Behavioral
The intervention consisted of a 12-week moderate-intensity walking program supported by a commercially available wearable device. Participants were instructed to walk five days per week for approximately 30 minutes per session. Walking intensity was guided by a rating of perceived exertion of 11-13. An Apple Watch was used to record daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence.
The intervention consisted of a 12-week moderate-intensity walking program supported by a commercially available wearable device. Participants were instructed to walk five days per week for approximately 30 minutes per session. Walking intensity was guided by a rating of perceived exertion of 11-13. An Apple Watch was used to record daily step counts, walking duration, and estimated caloric expenditure. Weekly feedback was provided through the LINE messaging application and face-to-face check-ins to support self-monitoring, reinforce walking goals, and monitor adherence.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment
Prazo: Baseline, week 4, week 8, and week 12
Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), a brief screening tool that evaluates multiple cognitive domains, including visuospatial ability, executive function, attention, memory, language, abstraction, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Baseline, week 4, week 8, and week 12

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Loneliness Assessed by the 8-item UCLA Loneliness Scale
Prazo: Baseline, week 4, week 8, and week 12
Loneliness was assessed using the 8-item UCLA Loneliness Scale (UCLA-8), which measures subjective feelings of loneliness and perceived social disconnection. Items are rated on a 4-point Likert-type scale, with higher total scores indicating greater loneliness.
Baseline, week 4, week 8, and week 12
Secondary Outcome Measure
Prazo: Baseline, week 4, week 8, and week 12
Loneliness was assessed using the 8-item UCLA Loneliness Scale (UCLA-8), which measures subjective feelings of loneliness and perceived social disconnection. Items are rated on a 4-point Likert-type scale, with higher total scores indicating greater loneliness.
Baseline, week 4, week 8, and week 12

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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 (Real)

1 de janeiro de 2026

Conclusão Primária (Real)

30 de maio de 2026

Conclusão do estudo (Real)

30 de maio de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de junho de 2026

Primeira postagem (Real)

16 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB115-029-B (Outro identificador: Research Ethics Committee Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Plan to Share IPD:

Yes

IPD Sharing Plan Description:

Deidentified individual participant data that underlie the results reported in this study may be made available from the corresponding investigator upon reasonable request. Data sharing will be considered after review of the scientific purpose of the request and approval by the investigator, subject to applicable ethical and privacy regulations.

IPD Sharing Supporting Information Type:

Study Protocol Statistical Analysis Plan

Time Frame:

Data may be available beginning 6 months after publication of the main study results and for 3 years thereafter.

Access Criteria:

Researchers who provide a methodologically sound proposal may request access to deidentified data for academic and non-commercial research purposes. Requests should be directed to the corresponding investigator. Data will be shared only after approval of the request and, where applicable, completion of a data use agreement.

URL:

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Prazo de Compartilhamento de IPD

Data may be available beginning 6 months after publication of the main study results and for 3 years thereafter.

Critérios de acesso de compartilhamento IPD

Researchers who provide a methodologically sound proposal may request access to deidentified data for academic and non-commercial research purposes. Requests should be directed to the corresponding investigator. Data will be shared only after approval of the request and, where applicable, completion of a data use agreement.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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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