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Wearable-Assisted Walking for Cognitive Function and Loneliness in Older Adults

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07650292
Acronym
WAW-CogLon
Enrollment
120
Registered
2026-06-16
Start date
2026-01-01
Completion date
2026-05-30
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conditions or Focus of Study: Cognitive Function Loneliness Aging Physical Activity

Keywords

Conditions or Focus of Study:, Cognitive Function, Loneliness

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALWearable-Assisted Walking Program

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.

Sponsors

National Taiwan College of Performing Arts
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Masking description

Outcome assessments were conducted by trained assessors who were not involved in delivering the intervention and did not have access to the randomization sequence.

Intervention model description

Participants were randomly assigned in a 1:1 ratio to either a wearable-assisted walking intervention group or a usual-care control group. The intervention lasted 12 weeks, and outcomes were assessed at baseline, week 4, week 8, and week 12.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive Function Assessed by the Montreal Cognitive AssessmentBaseline, week 4, week 8, and week 12Cognitive 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.

Secondary

MeasureTime frameDescription
Change in Loneliness Assessed by the 8-item UCLA Loneliness ScaleBaseline, week 4, week 8, and week 12Loneliness 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.
Secondary Outcome MeasureBaseline, week 4, week 8, and week 12Loneliness 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026