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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Upper limb grip strength
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 65 years or older residing in long-term care facilities and diagnosed with sarcopenia, defined as:
- •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.
- •Able to stand with assistive devices (e.g., walker), transfer from bed to chair using a wheelchair, or ambulate independently.
- •Clear consciousness, able to communicate, and able to provide informed consent.
- •Willing to participate and comply with the exercise intervention.
Exclusion Criteria
- •Impaired consciousness.
- •Unsuitable for wearing the device due to any leg-related medical condition.
- •Unable to perform aerobic or resistance training due to neurological or musculoskeletal disorders.
- •History of head injury resulting in cognitive impairments such as memory or attention deficits.
- •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
- •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.
- •Diagnosed with depression or experienced major life events in the past six months.
- •Fracture, sports injury of the limbs, stroke, dementia, or other major illness within the past six months.
- •Individuals with infectious disease risks.
Arms & Interventions
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.
Intervention: Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activity (Behavioral)
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.
Outcomes
Primary Outcomes
Upper limb grip strength
Time Frame: From enrollment to the end of treatment at 12 weeks
Grip strength was assessed using the Jamar 5030J1 analog dynamometer. Participants performed two consecutive grip tests with their dominant hand, and the highest value from the two trials was recorded. Grip strength values indicating possible sarcopenia are \<28 kg for males and \<18 kg for females.
Calf and arm circumferences
Time Frame: From enrollment to the end of treatment at 12 weeks
Calf and arm circumferences will be measured using a tape measure. Calf circumference: measured in a seated position at the widest part of the calf. A value \<34 cm for males and \<33 cm for females indicates risk of sarcopenia. Arm circumference: measured at the midpoint of the non-dominant upper arm. A value ≤28.6 cm for males and ≤27.5 cm for females indicates risk of sarcopenia.
Secondary Outcomes
- Cognitive Function(From enrollment to the end of treatment at 12 weeks.)
- Quality of Life Assessed Using WHOQOL-BREF(From enrollment to the end of treatment at 12 weeks.)
- Range of Motion(From enrollment to the end of treatment at 12 weeks)
- Depressive Symptoms Assessed Using the Chinese Version of the Geriatric Depression Scale-15 (CT-GDS-15)(From enrollment to the end of treatment at 12 weeks.)
- Activities of Daily Living (ADL)(From enrollment to the end of treatment at 12 weeks.)
Investigators
ZENG SIOU RONG
Co-Investigator
Tri-Service General Hospital