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NCT Number: NCT07779824

The Effect of an AIoT-Based Smart Exercise System in Older Adults

This clinical trial aims to evaluate the effectiveness of an artificial intelligence of things (AIoT)-based exercise system for seniors. Participants will undergo a 12-week AIoT-based cycle ergometer training program. Physical fitness and functional performance will be assessed at baseline and after completion of the intervention. Throughout the intervention, exercise-related data, including exercise duration, workload, heart rate, oxygen consumption, perceived exertion, and facial expressions, will be continuously and simultaneously collected for analysis.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I-Shou University

Kaohsiung City, 824, Taiwan

Location status: Recruiting

Location contact

Chih-Chun Lin

CONTACT

[email protected]

+886-76151100 Ext. 7566

About this study

At baseline (Week 0), participants will undergo a personal health assessment and physical fitness evaluation. The health assessment includes the collection of demographic information, medical history, and general health status. The physical fitness assessment includes measurement of body composition, muscle strength, balance, flexibility, walking speed, and other relevant physical fitness measures.

Following the baseline assessment, the participants will undergo the exercise program based on an AIoT-based exercise system twice weekly for 12 weeks. blood pressure will assessed before each exercise for safety concern. At Week 13, participants will undergo the same evaluations conducted at baseline. In addition, a user experience questionnaire will be administered.

During the exercise sessions, exercise-related metrics, including workload, cadence (revolutions per minute, RPM), exercise duration, heart rate, and facial action units (AUs), will be continuously recorded in real time. Ratings of perceived exertion will also be collected at regular intervals throughout the exercise sessions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult over 50 years old
  • No significant limb disability or joint deformation
  • No history of cardiovascular disease
  • Never lost balance due to dizziness in the past 12 months

Exclusion criteria

  • Limb disability or joint deformation
  • History of cardiovascular disease
  • Lost balance due to dizziness in the past 12 months
  • Cognitive deficits

Treatment and study plan

AIoT-based cycle ergometer exercise system

Device

AIoT-based cycle ergometer exercise system The system also continuously records exercise-related device data, personal physiological parameters, and facial action units in a structured and systematic manner.

Primary outcomes

  1. 30 second chair stand test

    Time frame: baseline

    Number of full stands that can completed in 30 seconds with arms folded across chest.

  2. 30 second chair stand test

    Time frame: after 12-week intervention

    Number of full stands that can be completed 30 seconds with arms folded across chest.

Secondary outcomes

  1. BMI

    Time frame: baseline

    Sarcopenia weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).

  2. BMI

    Time frame: after 12-week intervention

    Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).

  3. Up and Go test

    Time frame: baseline

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

  4. Up and Go test

    Time frame: after 12-week intervention

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

  5. Six-minute walk test

    Time frame: baseline

    To walk as much as possible within six minutes and measure the total distance traveled.

  6. Six-minute walk test

    Time frame: after 12-week intervention

    To walk as much as possible within six minutes and measure the total distance traveled.

  7. SMI

    Time frame: baseline

    Skeletal muscle mass index (SMI), which is the sum of the muscle masses of the four limbs as appendicular skeletal mass (ASM) in kilograms divided by the square of height in meters, is detected by TANITA MC-780MA body composition analyzer.

  8. SMI

    Time frame: after 12-week intervention

    Skeletal muscle mass index (SMI), which is the sum of the muscle masses of the four limbs as appendicular skeletal mass (ASM) in kilograms divided by the square of height in meters, is detected by TANITA MC-780MA body composition analyzer.

  9. Back scratch

    Time frame: baseline

    Back scratch with one hand reaching over shoulder and one up the middle of the back, the distance (cm) between extended middle fingers is recorded.

  10. Back scratch

    Time frame: after 12-week intervention

    Back scratch with one hand reaching over shoulder and one up the middle of the back, the distance (cm) between extended middle fingers is recorded.

  11. Chair sit-&-reach test

    Time frame: baseline

    From a sitting position at front of chair, with leg extended and hands reaching toward toes, the distance (cm) between extended fingers and tip of toe is recorded.

  12. Chair sit-&-reach test

    Time frame: after 12-week intervention

    From a sitting position at front of chair, with leg extended and hands reaching toward toes, the distance (cm) between extended fingers and tip of toe is recorded.

  13. 2-minute step test

    Time frame: baseline

    2-minute step test is to complete steps in 2 minutes. Number of full steps completed in 2 minutes is recorded.

  14. 2-minute step test

    Time frame: after 12-week intervention

    2-minute step test is to complete steps in 2 minutes. Number of full steps completed in 2 minutes is recorded.

  15. Single leg balance with eyes open test

    Time frame: baseline

    Participant is instructed to stand by one leg with eye open, the number of seconds is recorded.

  16. Single leg balance with eyes open test

    Time frame: after 12-week intervention

    Participant is instructed to stand by one leg with eye open, the number of seconds is recorded.

  17. Hand grip strength test

    Time frame: baseline

    Hand grip strength test is performed by HandGRIP Dynamometer

  18. Hand grip strength test

    Time frame: after 12-week intervention

    Hand grip strength test is performed by HandGRIP Dynamometer

  19. SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)

    Time frame: baseline

    Risk factors for fractures and falls and has grown to look at various determinants of successful aging. Three questions about frailty and two questions about depression.

  20. SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)

    Time frame: after 12-week intervention

    Risk factors for fractures and falls and has grown to look at various determinants of successful aging. Three questions about frailty and two questions about depression.

  21. SARC-F

    Time frame: baseline

    The SARC-F questionnaire is a Fast diagnostic test for SARCopenia that assesses strength, assistance in walking, rising from a chair, climbing stairs, and falls. Scores range from 0 to 10, with scores ≥4 indicating a higher risk of sarcopenia.

  22. SARC-F

    Time frame: after 12-week intervention

    The SARC-F questionnaire is a Fast diagnostic test for SARCopenia that assesses strength, assistance in walking, rising from a chair, climbing stairs, and falls. Scores range from 0 to 10, with scores ≥4 indicating a higher risk of sarcopenia.

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

    Time frame: baseline

    The EQ-5D is a standardized questionnaire that assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher scores indicate greater health problems.

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

    Time frame: after 12-week intervention

    The EQ-5D is a standardized questionnaire that assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher scores indicate greater health problems.

  25. QUEST (Questionnaire for satisfaction)

    Time frame: after 12-week intervention

    The 8 items of the questionnaire included Dimensions, Weight, Ease in Adjusting, Safety and Security, Durability, Ease of Use, Comfortable, and Effectiveness. Each item employed a 5-point scale, with 1-point representing not satisfied at all, and 5-point representing very satisfied. Evaluation of Satisfaction with Assistive Technology.

  26. System Usability Scale (SUS)

    Time frame: after 12-week intervention

    The System Usability Scale (SUS) is a reliable, 10-item Likert-scale questionnaire utilized to provide a global evaluation of a system's usability and user-friendliness. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate better system usability.

  27. Facial Movement

    Time frame: Periprocedural

    Facial movement will be recorded by video during exercise.

  28. Heart Rate

    Time frame: Periprocedural

    Heart rate is monitored continuously during exercise sessions.

  29. Rating of perceived exertion

    Time frame: Periprocedural

    Rating of perceived exertion is assessed during exercise sessions to characterize participants' perceived exercise intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Chien-Yu Hsu

CONTACT

[email protected]

+886-76151100 Ext. 7597

Chih-Chun Lin

CONTACT

[email protected]

+886-76151100 Ext. 7566

Sponsors and collaborators

Lead sponsor

I-Shou University

Other

Collaborators

  • National Cheng-Kung University Hospital

Registry information

Official study title

Development of a Precision Exercise System for Older Adults and People With Stroke Using Deep Learning and Facial Action Units

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 21, 2026
Registry last updated
Aug 21, 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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