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.

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.

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.

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

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.

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