NCT07197528

Effectiveness of Smart-Assisted Rehabilitation Exercise Training on the Physical and Mental Health of Older Adults in Long-Term Care Facilities

Effectiveness of Precision Rehabilitative Exercise Training on Sarcopenia, Joint Range of Motion, Cognitive Function, Activities of Daily Living, Quality of Life, and Mood Status in Elderly Residents of Long-Term Care Facilities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the effectiveness of a smart-assisted rehabilitation system on the physical and mental health of elderly residents in long-term care facilities through exercise training. The specific aim of this study is to investigate the effects of a 12-week exercise training program using a smart-assisted rehabilitation system on sarcopenia, joint range of motion, cognitive function, activities of daily living, functional status, quality of life, and emotional well-being among institutionalized older adults. Participants will be divided into an experimental group and a control group for comparison to assess whether the intervention improves outcomes such as sarcopenia, joint mobility, cognitive function, daily living abilities, overall functional status, quality of life, and emotional state. Participants in the experimental group will receive the "KNEESUP" smart medical rehabilitation system, provided by a co-investigator. A rehabilitation physician will design an individualized, progressive exercise program. The intervention is planned for 12 weeks, with a frequency of 3 days per week, 2 sessions per day, totaling 72 sessions.

Detailed description

This clinical trial aims to evaluate the effectiveness of a 12-week exercise intervention using an intelligent rehabilitation assistance system (KNEESUP) in improving the physical and mental health of institutionalized older adults with sarcopenia in long-term care facilities. With the rapid aging of the population, long-term care institutions have become crucial in supporting the quality of life for older adults. Residents in these settings often face compounded challenges, including chronic illnesses, reduced physical function, cognitive decline, and psychosocial issues such as loneliness and depression. These conditions increase the burden on healthcare systems and care staff. While exercise interventions are known to be effective in promoting physical and mental well-being in older adults, traditional standardized programs may lack individualization and precision. This study introduces a smart rehabilitation system that combines wearable technology and personalized exercise prescriptions designed by a physical medicine and rehabilitation physician. The system allows real-time monitoring and feedback, which enhances safety, motivation, and adherence. The intervention aligns with trends in post-pandemic digital health solutions and aims to integrate medical technology into routine elder care. Study Design A randomized controlled trial will be conducted. Eligible participants (aged ≥65 with sarcopenia, able to stand with assistance or walk with/without aid, and cognitively intact) will be randomly assigned to either an intervention or control group in a 1:1 ratio. The sample size was calculated using G\*Power, estimating 42 participants to account for a 20% dropout rate. Intervention group: Receives a 12-week progressive resistance training program using the KNEESUP smart rehabilitation system. Training will occur 3 times per week, twice per day, totaling 72 sessions. Exercises include lower-limb strengthening through progressive stages (bed, seated, and standing), designed by a team of multidisciplinary experts and monitored via wearable sensors. Control group: Continues routine care and usual physical activity without additional intervention. Outcome Measures Participants will be assessed pre- and post-intervention on the following variables: Sarcopenia indicators: Grip strength, limb circumference Joint range of motion: Measured with goniometer (upper limbs) and the KNEESUP system (lower limbs) Cognitive function: Short Portable Mental Status Questionnaire (SPMSQ) Daily living function: Barthel Index Functional status: Comprehensive Geriatric Assessment (CGA) Quality of life: WHOQOL-BREF (Taiwan version) Emotional state: Geriatric Depression Scale (GDS-15) Basic demographic and lifestyle data: Age, sex, education, comorbidities, social support, and physical activity habits Statistical Analysis Data will be analyzed using SPSS. Descriptive statistics (mean, SD, percentage) and inferential statistics (independent t-tests, chi-square tests, ANOVA, and generalized estimating equations \[GEE\]) will be used to assess within-group and between-group differences, and group × time interaction effects. Significance is set at α = 0.05. Data Management and Confidentiality All data will be anonymized. Paper and electronic data will be securely stored and encrypted. Data will be destroyed 5 years after study completion. Only authorized personnel will have access. Ethical Considerations The study has IRB approval and informed consent will be obtained from all participants or their legal guardians. Risks (e.g., muscle soreness or fatigue) will be mitigated with one-on-one supervision. Emergency procedures and referral systems are in place if adverse events occur. Expected Impact This study is expected to provide evidence supporting the feasibility and effectiveness of smart rehabilitation systems in long-term care. It may serve as a model for future eldercare strategies, inform policy, and contribute to the development of precision geriatric rehabilitation approaches.

Conditions

• Sarcopenia in Elderly
• Rehabilitation Exercise
• Long Term Care

Interventions

Type	Name	Description
BEHAVIORAL	Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activity	Interventions Behavioral: Smart-assisted rehabilitation exercise system ("KNEESUP") A wearable smart-assisted rehabilitation system providing personalized, progressive lower limb resistance training for elderly residents with sarcopenia in long-term care institutions. The system includes real-time monitoring, feedback, and remote adjustment by rehabilitation specialists. Unlike traditional programs, it integrates sensor technology to track knee joint angles and exercise performance, enabling precise and adaptive training. Other: Usual care / routine physical activity Participants follow standard daily activities and rehabilitation provided by the long-term care facility, without the smart-assisted rehabilitation system.

Timeline

• Start date: 2025-02-17
• Primary completion: 2025-05-18
• Completion: 2025-05-18
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: Taiwan