Wearable-Assisted Walking for Cognitive Function and Loneliness in Older Adults (WAW-CogLon)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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New Taipei City, Tchaj-wan, 251301
- National Taiwan College of Performing Arts
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Žádný zásah: 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.
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Experimentální: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Cognitive Function Assessed by the Montreal Cognitive Assessment
Časové okno: Baseline, week 4, week 8, and week 12
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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.
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Baseline, week 4, week 8, and week 12
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Loneliness Assessed by the 8-item UCLA Loneliness Scale
Časové okno: Baseline, week 4, week 8, and week 12
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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.
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Baseline, week 4, week 8, and week 12
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Secondary Outcome Measure
Časové okno: Baseline, week 4, week 8, and week 12
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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.
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Baseline, week 4, week 8, and week 12
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IRB115-029-B (Jiný identifikátor: Research Ethics Committee Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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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Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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