Effectiveness of Smart-Assisted Rehabilitation Exercise Training on the Physical and Mental Health of Older Adults in Long-Term Care Facilities
NCT ID: NCT07197528
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2025-02-17
2025-05-18
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
Experimental: Intervention Group Participants will receive a 12-week exercise training program using the smart-assisted rehabilitation system "KNEESUP." The training includes progressive resistance exercises tailored to individual functional abilities, conducted three times per week with two sessions per day. The system provides real-time monitoring, feedback, and remote adjustments by rehabilitation specialists.
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.
Control Group
Participants will receive usual care, including standard daily activities and routine rehabilitation therapies provided by the long-term care facility, without use of the smart-assisted rehabilitation system.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Handgrip strength: \<28 kg for males or \<18 kg for females, or
* Calf circumference (10 cm below the knee): \<34 cm for males or \<33 cm for females.
2. Able to stand with assistive devices (e.g., walker), transfer from bed to chair using a wheelchair, or ambulate independently.
3. Clear consciousness, able to communicate, and able to provide informed consent.
4. Willing to participate and comply with the exercise intervention.
Exclusion Criteria
2. Unsuitable for wearing the device due to any leg-related medical condition.
3. Unable to perform aerobic or resistance training due to neurological or musculoskeletal disorders.
4. History of head injury resulting in cognitive impairments such as memory or attention deficits.
5. Assessed by a rehabilitation specialist as having absolute or relative contraindications to exercise training, such as:
* Severe myocardial ischemia
* Myocardial infarction within the past 6 months
* Unstable angina
* Uncontrolled arrhythmias causing symptoms or hemodynamic instability
* Severe aortic valve stenosis
6. Deemed unsuitable to participate in the study by a rehabilitation specialist due to conditions such as end-stage renal disease requiring dialysis, terminal cancer, or ongoing chemotherapy/radiation therapy.
7. Diagnosed with depression or experienced major life events in the past six months.
8. Fracture, sports injury of the limbs, stroke, dementia, or other major illness within the past six months.
9. Individuals with infectious disease risks.
65 Years
ALL
No
Sponsors
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Tri-Service General Hospital
OTHER
Responsible Party
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ZENG SIOU RONG
Co-Investigator
Locations
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Banqiao Veterans Home of Veterans Affairs Council, R.O.C.
New Taipei City, Banqiao Dist, Taiwan
Countries
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Other Identifiers
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A202405161
Identifier Type: -
Identifier Source: org_study_id
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