Effects of a Wearable-Assisted Walking Program on Longitudinal Trajectories of Cognitive Function and Loneliness in Older Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function Assessed by the Montreal Cognitive Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Outcome assessments were conducted by trained assessors who were not involved in delivering the intervention and did not have access to the randomization sequence.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Wearable-Assisted Walking Program (Behavioral)
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.
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.
干预措施: Wearable-Assisted Walking Program (Behavioral)
结局指标
主要结局
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment
时间窗: 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.
次要结局
- Change in Loneliness Assessed by the 8-item UCLA Loneliness Scale(Baseline, week 4, week 8, and week 12)
- Secondary Outcome Measure(Baseline, week 4, week 8, and week 12)
研究者
CHENG-EN WU
Assistant Professor
National Taiwan College of Performing Arts