National Taiwan College of Performing Arts
New Taipei City, 251301, Taiwan
Completed
NCT Number: NCT07650292
Wearable-Assisted Walking for Cognitive Function and Loneliness in Older Adults
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.
Completed
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Notify MeKey information
Age range
65 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Wearable-Assisted Walking Program
BehavioralThe 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.
Primary outcomes
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Change in Cognitive Function Assessed by the Montreal Cognitive Assessment
Time frame: 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.
Secondary outcomes
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Change in Loneliness Assessed by the 8-item UCLA Loneliness Scale
Time frame: 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.
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Secondary Outcome Measure
Time frame: 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.
Sponsors and collaborators
Lead sponsor
National Taiwan College of Performing Arts
Other
Registry information
Official study title
Effects of a Wearable-Assisted Walking Program on Longitudinal Trajectories of Cognitive Function and Loneliness in Older Adults: A Randomized Controlled Trial
Acronym: WAW-CogLon
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jun 16, 2026
- Registry last updated
- Jun 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.