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Structured Self-Talk and Wearable-Assisted Walking for Physical Activity and Function in Older Adults

11 de agosto de 2026 atualizado por: CHENG-EN WU

Effects of Integrating Self-Talk Strategies With Wearable Technology on Physical Activity, Functional Performance, and Psychological Determinants in Community-Dwelling Older Adults: A Randomized Controlled Trial

The goal of this randomized clinical trial was to examine whether adding structured self-talk to wearable-assisted walking could support physical activity and physical function in community-dwelling older adults. The study also examined whether wearable-assisted walking provided benefits compared with a walking program without wearable feedback.

Participants were randomly assigned to one of three groups for 12 weeks: (1) wearable-assisted walking combined with structured self-talk, (2) wearable-assisted walking without structured self-talk, or (3) a walking-only active control condition. All groups followed the same moderate-intensity walking schedule.

The main questions were whether wearable-assisted walking was associated with better physical activity and functional performance than walking alone, and whether adding structured self-talk provided additional benefits beyond wearable-assisted walking. Physical activity, functional performance, and other protocol-specified health-related measures were assessed before and after the intervention.

Visão geral do estudo

Descrição detalhada

This was a 12-week, three-arm, parallel-group randomized controlled trial conducted in community-dwelling older adults. Sixty participants were allocated in a 1:1:1 ratio to an integrated intervention group, a technology-assisted group, or an active control group.

All three groups followed the same moderate-intensity walking prescription consisting of three 30-minute sessions per week for 12 weeks, with exercise intensity guided by a rating of perceived exertion of 11-13. The integrated intervention group used a wearable activity device that provided real-time activity feedback and also received structured self-talk training. The self-talk component was designed to help participants use task-focused and motivational statements during walking and progressed from awareness and instruction to regulation and self-directed use over the intervention period.

The technology-assisted group followed the same walking prescription and used the same wearable activity device but did not receive structured self-talk training. The active control group followed the same walking prescription without wearable feedback or structured self-talk and recorded exercise participation using a paper-based log.

Assessments were conducted at baseline and after completion of the 12-week intervention. Outcome assessors were blinded to group allocation. The study was designed to distinguish the effects associated with wearable-assisted walking from any additional effects associated with adding structured self-talk.

Tipo de estudo

Intervencional

Inscrição (Real)

60

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

    • 臺灣省
      • Taipei, 臺灣省, Taiwan, 244
        • Senior Community Activity Center

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:

-

Inclusion Criteria:

Aged 65 years or older. Community-dwelling and independent in activities of daily living. Able to ambulate safely without physical assistance; use of a cane was permitted.

Cleared for participation in moderate-intensity physical activity using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).

Montreal Cognitive Assessment (MoCA) score of 24 or higher. Sufficient literacy and communication ability in Chinese to understand study instructions and complete study procedures.

Access to a smartphone and an internet connection. Able to independently perform basic smartphone and wearable-device operations, including charging the wearable device.

Willing to wear the study wearable device and comply with the intervention procedures.

Exclusion Criteria:

A medically treated fall within the previous 3 months. A major cardiovascular event within the previous 6 months. Lower-extremity surgery within the previous 6 months. Severe neuromuscular disease that could interfere with safe participation or outcome assessment.

Severe visual or auditory impairment that could interfere with communication or study assessments.

Use of medications known to substantially affect cognitive function or muscle performance.

Concurrent participation in another structured exercise or rehabilitation program.

A medical contraindication to moderate-intensity exercise, including unstable chronic medical conditions as determined by a healthcare professional.

Severe psychiatric disorder or cognitive impairment that could interfere with adherence to study procedures.

Exclusion Criteria:

-

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: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Integrated Intervention Group
Participants received a 12-week moderate-intensity walking program combined with wearable-based activity feedback and structured self-talk training. Walking was prescribed three times per week for 30 minutes per session at a rating of perceived exertion of 11-13. The wearable device provided real-time step feedback and haptic alerts. Structured self-talk training was provided weekly and progressed through awareness, acquisition, regulation, and maintenance stages.
Participants performed moderate-intensity walking three times per week for 30 minutes per session over 12 weeks. Exercise intensity was prescribed at a rating of perceived exertion (RPE) of 11-13. This standardized walking program was provided to participants in all three study groups.
A wrist-worn wearable activity device was used to provide real-time step feedback and haptic vibration alerts during the 12-week walking intervention. The device was used as a behavioral feedback tool to support walking participation. Data from the intervention wearable device were not used as the research outcome measure.
Participants received weekly structured self-talk training throughout the 12-week intervention. The training was delivered by trained instructors and progressed through four stages: awareness, acquisition, regulation, and maintenance. Participants were taught to use structured motivational and instructional self-talk during walking and in response to wearable-generated feedback. Standardized scripts and fidelity checklists were used to support consistent intervention delivery.
Comparador Ativo: Technology-Assisted Group
Participants received the same 12-week moderate-intensity walking program and used the same wearable device for real-time activity feedback but did not receive structured self-talk training. Brief weekly contacts were limited to device operation, battery status, and wearing compliance and did not include psychological strategy training.
Participants performed moderate-intensity walking three times per week for 30 minutes per session over 12 weeks. Exercise intensity was prescribed at a rating of perceived exertion (RPE) of 11-13. This standardized walking program was provided to participants in all three study groups.
A wrist-worn wearable activity device was used to provide real-time step feedback and haptic vibration alerts during the 12-week walking intervention. The device was used as a behavioral feedback tool to support walking participation. Data from the intervention wearable device were not used as the research outcome measure.
Comparador Ativo: Active Control Group
Participants received the same 12-week moderate-intensity walking program without wearable-based activity feedback or structured self-talk training. Participants recorded the date, duration, and rating of perceived exertion of each walking session using a paper-based exercise log.
Participants performed moderate-intensity walking three times per week for 30 minutes per session over 12 weeks. Exercise intensity was prescribed at a rating of perceived exertion (RPE) of 11-13. This standardized walking program was provided to participants in all three study groups.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Time Spent in Moderate-to-Vigorous Physical Activity
Prazo: Baseline and 12 weeks
Time spent in moderate-to-vigorous physical activity was assessed using a research-grade ActiGraph triaxial accelerometer during 7-day monitoring periods at baseline and after the 12-week intervention.
Baseline and 12 weeks
Average Daily Step Count
Prazo: Baseline and 12 weeks
Average daily step count was measured using a research-grade ActiGraph triaxial accelerometer worn on the non-dominant wrist. Daily steps were summarized across valid monitoring days at baseline and after the 12-week intervention. Higher values indicate greater daily physical activity.
Baseline and 12 weeks
Five-Times Sit-to-Stand
Prazo: Baseline and 12 weeks
Lower-extremity functional performance was assessed using the five-times sit-to-stand test. Completion time was recorded in seconds, with shorter times indicating better performance.
Baseline and 12 weeks
Handgrip Strength
Prazo: Baseline and 12 weeks
Upper-extremity muscle strength was assessed using dominant-hand grip strength. Strength was recorded in kilograms, with higher values indicating greater grip strength.
Baseline and 12 weeks
Timed Up and Go
Prazo: Baseline and 12 weeks
Dynamic balance and mobility were assessed using the Timed Up and Go test. Completion time was recorded in seconds, with shorter times indicating better performance.
Baseline and 12 weeks
Appendicular Skeletal Muscle Mass Index
Prazo: Baseline and 12 weeks
Appendicular skeletal muscle mass index (ASMI) was assessed using an InBody 370S bioelectrical impedance analyzer and calculated as appendicular skeletal muscle mass divided by height squared (kg/m²). Higher values indicate greater appendicular muscle mass relative to height.
Baseline and 12 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Exercise Self-Efficacy
Prazo: Baseline and 12 weeks
Exercise self-efficacy was assessed using the Exercise Self-Efficacy Scale (ESES), which evaluates confidence in continuing exercise under challenging situations. Higher scores indicate greater exercise self-efficacy.
Baseline and 12 weeks
Exercise Motivation / Behavioral Regulation
Prazo: Baseline and 12 weeks
Exercise motivation and internalization were assessed using a behavioral regulation in exercise questionnaire to evaluate the degree of autonomous motivation toward exercise.
Baseline and 12 weeks

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: CHENG-EN WU, phd, National Taiwan College of Performing Arts

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)

15 de março de 2026

Conclusão Primária (Real)

30 de junho de 2026

Conclusão do estudo (Real)

30 de junho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

11 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de agosto de 2026

Primeira postagem (Real)

17 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be made publicly available because the informed consent obtained for this study did not include unrestricted public sharing of individual-level participant data. De-identified aggregate data may be provided upon reasonable request, subject to applicable ethical and institutional requirements.

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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