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

11 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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:

-

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Time Spent in Moderate-to-Vigorous Physical Activity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Exercise Self-Efficacy
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: CHENG-EN WU, phd, National Taiwan College of Performing Arts

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 marzo 2026

Completamento primario (Effettivo)

30 giugno 2026

Completamento dello studio (Effettivo)

30 giugno 2026

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 agosto 2026

Primo Inserito (Effettivo)

17 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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