Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

10 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

120

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

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

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

Descrizione

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.

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: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Nessun intervento: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Loneliness Assessed by the 8-item UCLA Loneliness Scale
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

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)

1 gennaio 2026

Completamento primario (Effettivo)

30 maggio 2026

Completamento dello studio (Effettivo)

30 maggio 2026

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

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

Descrizione del piano 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:

Leave blank

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

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 .

Prove cliniche su Wearable-Assisted Walking Program

Sottoscrivi