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Completed

NCT Number: NCT07698912

The Effects of an AIoT-Based Exercise System on Frail Older Adults

This clinical trial aims to evaluate the effectiveness of an Artificial Intelligence of Things (AIoT)-based feedback assistive strengthening ergometer (AIFASE) exercise system on frail older adults in geriatric wards. Baseline assessments will include physical fitness, functional performance, and frailty severity. Muscle strength of the major muscle groups in the upper and lower extremities will be evaluated at both baseline and post-intervention. Throughout the intervention, exercise-related data, including exercise duration, workload, heart rate, rate of perceived exertion (RPE), and blood oxygen saturation (SpO2) will be continuously and simultaneously collected for analysis.

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Key information

Conditions

Frail Older Adults Behavior Frailty Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, Taiwan, 704

About this study

At baseline, participants will undergo a personal health assessment and physical fitness evaluation. The personal health assessment includes collection of demographic information, past medical history, general health status, and clinical frailty scale. Physical fitness assessment consists of handgrip strength, Timed Up and Go test and 4-meter walk test. These baseline assessments will be used to individualize and guide the AIFASE exercise program.

Following the baseline assessment, the intervention group will undergo training using an AIFASE exercise system. Muscle strength of the major muscle groups in the upper and lower extremities (elbow flexors, elbow extensors, knee flexors, and knee extensors) will be evaluated at both baseline and post-intervention.

During the exercise sessions, exercise-related metrics, including workload, cadence (revolutions per minute, RPM), exercise duration, heart rate, and rate of perceived exertion (RPE), and blood oxygen saturation (SpO2) will be continuously recorded in real time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult over 65 years old
  • The Clinical Frailty Scale (CFS) score of 3 to 7 (hospitalized patients)

Exclusion criteria

  • Limb disability or joint deformation
  • Admission to the intensive care unit, scheduled surgery, anticipated discharge within three days, medical contraindications to physical activity, or enrollment in hospice care.

Treatment and study plan

AIoT-based Feedback Assistive Strengthening Ergometer

Device

The system provides individualized exercise programs based on baseline physical fitness levels and dynamically adjusts the training intensity according to physiological feedback. The system also continuously records exercise-related device data, personal physiological parameters.

Primary outcomes

  1. Muscle strength of knee extensors

    Time frame: baseline

    Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.

  2. Muscle strength of knee extensors

    Time frame: through study completion, an average of 13 days

    Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.

Secondary outcomes

  1. Timed Up and Go test (TUG)

    Time frame: basline

    Number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.

  2. Gait speed (4-meter walk test)

    Time frame: baseline

    To measure the gait speed when participants walk across the test zone (4 meter).

  3. Clinical Frailty Scale (CFS)

    Time frame: baseline

    Clinical Frailty Scale (CFS), a validated 9-point instrument in which a score of 1 indicates very fit status and a score of 9 indicates terminal illness.

  4. Short Portable Mental Status Questionnaire (SPMSQ)

    Time frame: baseline

    The questionnaire is a brief 10-item clinical tool to quickly assess cognitive impairment in older adults. It evaluates short- and long-term memory, orientation, information about current events, and mathematical capacity.

  5. Geriatric Depression Scale (GDS-5)

    Time frame: baseline

    The survey is a brief 5 questions to quickly assess depression, with scores ≥2 indicating possible depressive disorder in older adults.

  6. Activities of Daily Living (ADLs)

    Time frame: baseline

    The ability to maintain daily living is evaluated by personal hygiene, dressing, eating, toileting, and mobility.

  7. Activities of Daily Living (ADLs)

    Time frame: through study completion, an average of 13 days

    The ability to maintain daily living is evaluated by personal hygiene, dressing, eating, toileting, and mobility.

  8. EQ-5D (EuroQol- 5 Dimensions)

    Time frame: baseline

    EQ-5D is a standardized instrument with 5-item questionnaire for measuring generic health status. EQ-5D was first introduced in 1990 by the EuroQol Group. In which health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333(having extreme problems in all dimensions).

  9. Mini Nutritional Assessment-Short Form (MNA-SF)

    Time frame: baseline

    The nutritional status is evaluated by food intake, weight loss, mobility, stress, neuropsychology, and mobility. The scores less than 7 indicated malnutrition.

  10. Muscle strength of elbow flexors

    Time frame: baseline

    Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.

  11. Muscle strength of elbow flexors

    Time frame: through study completion, an average of 13 days

    Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.

  12. Muscle strength of elbow extensors

    Time frame: baseline

    Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.

  13. Muscle strength of elbow extensors

    Time frame: through study completion, an average of 13 days

    Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.

  14. Muscle strength of knee flexors

    Time frame: baseline

    Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.

  15. Muscle strength of knee flexors

    Time frame: through study completion, an average of 13 days

    Muscle strength of elbow flexors is assessed using a MicroFET2 handheld dynamometer.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

AIoT-Based Ergometer for Early Rehabilitation in Geriatric Wards: Supporting Physical Recovery in Frail Older Adult

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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