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

NCT07197528 | Completed

• 1 other identifier: A202405161
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia in Elderly; Rehabilitation Exercise; Long Term Care

Keywords

sarcopenia; elderly; rehabilitation; Long Term Care

Outcome Measures

Primary Outcomes (2)

• Upper limb grip strength

  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.

  From enrollment to the end of treatment at 12 weeks

• Calf and arm circumferences

  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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (5)

• Range of Motion

  From enrollment to the end of treatment at 12 weeks

• Cognitive Function

  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.

• Quality of Life Assessed Using WHOQOL-BREF

  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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activity

Control Group

NO INTERVENTION

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.

Interventions

Experimental Arm：Smart-assisted rehabilitation exercise system Control Arm：Usual care or routine physical activity BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Banqiao Veterans Home of Veterans Affairs Council, R.O.C.

New Taipei City, Banqiao Dist, 220250, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: September 29, 2025
• Study Start: February 17, 2025
• Primary Completion: May 18, 2025
• Study Completion: May 18, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)