ExerciseNCT07779824
The Effect of an AIoT-Based Smart Exercise System in Older Adults
A study testing AIoT-based cycle ergometer exercise system in people with Exercise and Seniors, run by I-Shou University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- AIoT-based cycle ergometer exercise system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Limb disability or joint deformation
- History of cardiovascular disease
- Lost balance due to dizziness in the past 12 months
- Cognitive deficits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
I-Shou University
Kaohsiung City, 824
Chih-Chun Lin, +886-76151100 Ext. 7566, chihchunlin@isu.edu.tw
About this study
Official title: Development of a Precision Exercise System for Older Adults and People With Stroke Using Deep Learning and Facial Action Units
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.
Read the detailed description
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.
- Being tested
- AIoT-based cycle ergometer exercise system
- Keywords
- Seniors, Exercise, facial action unit
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIoT-based cycle ergometer exercise systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AIoT-based Exercise | Experimental | Seniors participants will undergo a 12-week AIoT-based cycle ergometer exercise program. Receives: Device: AIoT-based cycle ergometer exercise system |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 second chair stand test
Number of full stands that can completed in 30 seconds with arms folded across chest.
Measured: baseline
30 second chair stand test
Number of full stands that can be completed 30 seconds with arms folded across chest.
Measured: Within 7 days after completion of the 12-week intervention
Secondary outcomes (29)
BMI
Sarcopenia weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
Measured: baseline
BMI
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
Measured: Within 7 days after completion of the 12-week intervention
Up and Go test
Number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
Measured: baseline
Up and Go test
Number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
Measured: Within 7 days after completion of the 12-week intervention
Six-minute walk test
To walk as much as possible within six minutes and measure the total distance traveled.
Measured: baseline
Six-minute walk test
To walk as much as possible within six minutes and measure the total distance traveled.
Measured: Within 7 days after completion of the 12-week intervention
SMI
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.
Measured: baseline
SMI
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.
Measured: Within 7 days after completion of the 12-week intervention
Back scratch
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.
Measured: baseline
Back scratch
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.
Measured: Within 7 days after completion of the 12-week intervention
Chair sit-&-reach test
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.
Measured: baseline
Chair sit-&-reach test
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.
Measured: Within 7 days after completion of the 12-week intervention
2-minute step test
2-minute step test is to complete steps in 2 minutes. Number of full steps completed in 2 minutes is recorded.
Measured: baseline
2-minute step test
2-minute step test is to complete steps in 2 minutes. Number of full steps completed in 2 minutes is recorded.
Measured: Within 7 days after completion of the 12-week intervention
Single leg balance with eyes open test
Participant is instructed to stand by one leg with eye open, the number of seconds is recorded.
Measured: baseline
Single leg balance with eyes open test
Participant is instructed to stand by one leg with eye open, the number of seconds is recorded.
Measured: Within 7 days after completion of the 12-week intervention
Hand grip strength test
Hand grip strength test is performed by HandGRIP Dynamometer
Measured: baseline
Hand grip strength test
Hand grip strength test is performed by HandGRIP Dynamometer
Measured: Within 7 days after completion of the 12-week intervention
SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)
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.
Measured: baseline
SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)
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.
Measured: Within 7 days after completion of the 12-week intervention
SARC-F
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.
Measured: baseline
SARC-F
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.
Measured: Within 7 days after completion of the 12-week intervention
EQ-5D (EuroQol- 5 Dimensions)
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.
Measured: baseline
EQ-5D (EuroQol- 5 Dimensions)
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.
Measured: Within 7 days after completion of the 12-week intervention
QUEST (Questionnaire for satisfaction)
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.
Measured: Within 7 days after completion of the 12-week intervention
System Usability Scale (SUS)
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.
Measured: Within 7 days after completion of the 12-week intervention
Facial Movement
Facial movement will be recorded by video during exercise.
Measured: Periprocedural
Heart Rate
Heart rate is monitored continuously during exercise sessions.
Measured: Periprocedural
Rating of perceived exertion
Rating of perceived exertion is assessed during exercise sessions to characterize participants' perceived exercise intensity.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 Feb 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I-Shou University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Responsible party
- Principal investigator, Chih-Chun Lin, I-Shou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779824
- Sponsor's protocol ID
- EMRP-114-162A
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy and confidentiality restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Precision Exercise System for Older Adults and People With Stroke Using Deep Learning and Facial Action Units
- ClinicalTrials.gov ID
- NCT07779824
- Acronym / sponsor ID
- EMRP-114-162A
- Keywords
- Seniors, Exercise, facial action unit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- I-Shou UniversityUniversity, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIoT-based Exercise | Experimental | Device: AIoT-based cycle ergometer exercise systemSeniors participants will undergo a 12-week AIoT-based cycle ergometer exercise program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Limb disability or joint deformation
- History of cardiovascular disease
- Lost balance due to dizziness in the past 12 months
- Cognitive deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIoT-based cycle ergometer exercise systemAIoT-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. | Device | AIoT-based Exercise |
Primary outcome
30 second chair stand test
Time frame: baseline
Number of full stands that can completed in 30 seconds with arms folded across chest.
30 second chair stand test
Time frame: Within 7 days after completion of the 12-week intervention
Number of full stands that can be completed 30 seconds with arms folded across chest.
29 secondary outcomes
BMI
Time frame: baseline
BMI
Time frame: Within 7 days after completion of the 12-week intervention
Up and Go test
Time frame: baseline
Up and Go test
Time frame: Within 7 days after completion of the 12-week intervention
Six-minute walk test
Time frame: baseline
Six-minute walk test
Time frame: Within 7 days after completion of the 12-week intervention
SMI
Time frame: baseline
SMI
Time frame: Within 7 days after completion of the 12-week intervention
Back scratch
Time frame: baseline
Back scratch
Time frame: Within 7 days after completion of the 12-week intervention
Chair sit-&-reach test
Time frame: baseline
Chair sit-&-reach test
Time frame: Within 7 days after completion of the 12-week intervention
2-minute step test
Time frame: baseline
2-minute step test
Time frame: Within 7 days after completion of the 12-week intervention
Single leg balance with eyes open test
Time frame: baseline
Single leg balance with eyes open test
Time frame: Within 7 days after completion of the 12-week intervention
Hand grip strength test
Time frame: baseline
Hand grip strength test
Time frame: Within 7 days after completion of the 12-week intervention
SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)
Time frame: baseline
SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)
Time frame: Within 7 days after completion of the 12-week intervention
SARC-F
Time frame: baseline
SARC-F
Time frame: Within 7 days after completion of the 12-week intervention
EQ-5D (EuroQol- 5 Dimensions)
Time frame: baseline
EQ-5D (EuroQol- 5 Dimensions)
Time frame: Within 7 days after completion of the 12-week intervention
QUEST (Questionnaire for satisfaction)
Time frame: Within 7 days after completion of the 12-week intervention
System Usability Scale (SUS)
Time frame: Within 7 days after completion of the 12-week intervention
Facial Movement
Time frame: Periprocedural
Heart Rate
Time frame: Periprocedural
Rating of perceived exertion
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to privacy and confidentiality restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIoT-based cycle ergometer exercise system in people with Exercise and Seniors, run by I-Shou University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Chun Lin (+886-76151100 Ext. 7566, chihchunlin@isu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 second chair stand test (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.