Elderly ExerciseNCT04137939
The Effect of IoT-based Smart Exercises System in the Senior Adults
A study testing smart exercise system in people with Elderly Exercise, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Subjects are divided into two groups, (1) Control (Ctrl) and (2) Smart Exercise (SE) group. Ctrl group are instructed to maintain their daily life. SE participants are instructed to do exercise with smart exercise system twice per week for 12 weeks. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly Exercise
- What is being tested?
- smart exercise system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2019to 31 Aug 2027
- 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
- Healthy volunteers accepted
- 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
National Cheng-Kung University
Tainan, Taiwan, 701
Li-Chieh Kuo, Ph. D., 886-62353535 ext. 5908, jkkuo@mail.ncku.edu.tw
About this study
Official title: Smart Health Care and Innovative Technology Service Model Plan : Development of Innovative Health Promotion System for Senior Adults
Subjects are divided into two groups, (1) Control (Ctrl) and (2) Smart Exercise (SE) group. Ctrl group are instructed to maintain their daily life. SE participants are instructed to do exercise with smart exercise system twice per week for 12 weeks. The physical fitness tests and questionnaire of both group are performed before and after the 12-week exercise program.
Read the detailed description
The smart exercise system contain an upper extremity cycle ergometer (UEE) and a lower extremity cycle ergometer (LEE). SE group are instructed to do once session of UEE and once session of LEE per week, 30 minute per session, lasting for 12 weeks. Before each exercise, the physiological parameter are measured to ensure safety. 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.
- Conditions
- Elderly Exercise
- Being tested
- smart exercise system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart exercise systemDevice
The smart exercise system contains an upper extremity ergometer (UEE) and a lower extremity ergometer (LEE). The revolutions per minute (RPM) of the ergometer are instructed to maintain in 55-65. The resistance of UEE is set from level 1 at the first session, and adjusted by rating of perceived exertion (RPE) of each user after each end of the session. The resistance of LEE is set from level 2 at the first session, and adjusted by rating of perceived exertion (RPE) of each user after each end of the session. 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 |
|---|---|---|
| Control group | No intervention | Ctrl group is instructed to maintain their original daily life |
| Smart Exercise group | Experimental | SE group are instructed to perform one session of upper extremity ergometer and one session of lower extremity ergometer in a week, 30 minute per session, lasting for 12 weeks. Receives: Device: smart 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 be completed in 30 seconds with arms folded across chest.
Measured: baseline
30 second chair stand test
number of full stands that can be completed in 30 seconds with arms folded across chest.
Measured: after 12-week intervention
Secondary outcomes (25)
BMI
Participant's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI) .
Measured: baseline
BMI
Participant's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI) .
Measured: after 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 bioelectrical impedance analysis.
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 bioelectrical impedance analysis.
Measured: after 12-week intervention
Back scratch
Back scratch: with one hand reaching over the 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 the shoulder and one up the middle of the back, the distance(cm) between extended middle fingers is recorded.
Measured: after 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: after 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: after 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: after 12-week intervention
8-foot up-&-go test
8-foot up-\&-go test: number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
Measured: baseline
8-foot up-&-go test
8-foot up-\&-go test: number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
Measured: after 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: after 12-week intervention
Hand grip strength test
hand grip strength test is performed by HandGRIP Dynamometer to detect the grip strength
Measured: baseline
Hand grip strength test
hand grip strength test is performed by HandGRIP Dynamometer to detect the grip strength
Measured: after 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: after 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
SARC-F
The SARC-F questionnaire is a Fast diagnostic test for SARCopenia. The questionnaire contains five items, which are Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls. The scores range from 0 to 10, with 0 to 2 points for each component. Score equal to or greater than 4 is predictive of sarcopenia and poor outcomes.
Measured: after 12-week intervention
SARC-F
The SARC-F questionnaire is a Fast diagnostic test for SARCopenia. The questionnaire contains five items, which are Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls. The scores range from 0 to 10, with 0 to 2 points for each component. Score equal to or greater than 4 is predictive of sarcopenia and poor outcomes.
Measured: baseline
EQ-5D (EuroQol- 5 Dimensions)
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).
Measured: baseline
EQ-5D (EuroQol- 5 Dimensions)
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).
Measured: after 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: after 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start15 Jul 2019
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Chieh Kuo, National Cheng-Kung University Hospital
- Investigators
- Li-Chieh Kuo, Ph. D., Study director, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137939
- Sponsor's protocol ID
- B-BR-106-072
- Status last verified
- Dec 2025
- First submitted
- 11 Sep 2019
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin CC, Lin YS, Yeh CH, Huang CC, Kuo LC, Su FC. An Exergame-Integrated IoT-Based Ergometer System Delivers Personalized Training Programs for Older Adults and Enhances Physical Fitness: A Pilot Randomized Controlled Trial. Gerontology. 2023;69(6):768-782. doi: 10.1159/000526951. Epub 2023 Jan 6.
PubMed 36617413
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Health Care and Innovative Technology Service Model Plan : Development of Innovative Health Promotion System for Senior Adults
- ClinicalTrials.gov ID
- NCT04137939
- Acronym / sponsor ID
- B-BR-106-072
- Conditions
- Elderly Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Oct 2019 (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.
Subjects are divided into two groups, (1) Control (Ctrl) and (2) Smart Exercise (SE) group. Ctrl group are instructed to maintain their daily life. SE participants are instructed to do exercise with smart exercise system twice per week for 12 weeks. The physical fitness tests and questionnaire of both group are performed before and after the 12-week exercise program.
Detailed description
The smart exercise system contain an upper extremity cycle ergometer (UEE) and a lower extremity cycle ergometer (LEE). SE group are instructed to do once session of UEE and once session of LEE per week, 30 minute per session, lasting for 12 weeks. Before each exercise, the physiological parameter are measured to ensure safety. 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Ctrl group is instructed to maintain their original daily life |
| Smart Exercise group | Experimental | Device: smart exercise systemSE group are instructed to perform one session of upper extremity ergometer and one session of lower extremity ergometer in a week, 30 minute per session, lasting for 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| smart exercise systemThe smart exercise system contains an upper extremity ergometer (UEE) and a lower extremity ergometer (LEE). The revolutions per minute (RPM) of the ergometer are instructed to maintain in 55-65. The resistance of UEE is set from level 1 at the first session, and adjusted by rating of perceived exertion (RPE) of each user after each end of the session. The resistance of LEE is set from level 2 at the first session, and adjusted by rating of perceived exertion (RPE) of each user after each end of the session. The system also continuously records exercise-related device data, personal physiological parameters, and facial action units in a structured and systematic manner. | Device | Smart Exercise group |
Primary outcome
30 second chair stand test
Time frame: baseline
number of full stands that can be completed in 30 seconds with arms folded across chest.
30 second chair stand test
Time frame: after 12-week intervention
number of full stands that can be completed in 30 seconds with arms folded across chest.
25 secondary outcomes
BMI
Time frame: baseline
BMI
Time frame: after 12-week intervention
SMI
Time frame: baseline
SMI
Time frame: after 12-week intervention
Back scratch
Time frame: baseline
Back scratch
Time frame: after 12-week intervention
Chair sit-&-reach test
Time frame: baseline
Chair sit-&-reach test
Time frame: after 12-week intervention
Six-minute walk test
Time frame: baseline
Six-minute walk test
Time frame: after 12-week intervention
2-minute step test
Time frame: baseline
2-minute step test
Time frame: after 12-week intervention
8-foot up-&-go test
Time frame: baseline
8-foot up-&-go test
Time frame: after 12-week intervention
Single leg balance with eyes open test
Time frame: baseline
Single leg balance with eyes open test
Time frame: after 12-week intervention
Hand grip strength test
Time frame: baseline
Hand grip strength test
Time frame: after 12-week intervention
SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)
Time frame: after 12-week intervention
SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)
Time frame: baseline
SARC-F
Time frame: after 12-week intervention
SARC-F
Time frame: baseline
EQ-5D (EuroQol- 5 Dimensions)
Time frame: baseline
EQ-5D (EuroQol- 5 Dimensions)
Time frame: after 12-week intervention
QUEST (Questionnaire for satisfaction)
Time frame: after 12-week intervention
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 8 Jul 2026.
- Derived from this study: PubMed 36617413Lin CC, Lin YS, Yeh CH, Huang CC, Kuo LC, Su FC. An Exergame-Integrated IoT-Based Ergometer System Delivers Personalized Training Programs for Older Adults and Enhances Physical Fitness: A Pilot Randomized Controlled Trial. Gerontology. 2023;69(6):768-782. doi: 10.1159/000526951. Epub 2023 Jan 6.
Related trials for Elderly Exercise
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
RecruitingPhase 2/3
Partner4Exercise Study
Cancer
Not yet recruiting
Smart Sock for Monitoring Walking and Supporting Physical Activity in Older Adults: A Family-Supported Feasibility Study
Walking Mesh
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.
Li-Chieh Kuo, Ph. D. study director
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smart exercise system in people with Elderly Exercise, run by National Cheng-Kung University Hospital 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 8 Jul 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 Li-Chieh Kuo, Ph. D. (886-62353535 ext. 5908, jkkuo@mail.ncku.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?
On the ClinicalTrials.gov record for NCT04137939, which also lists 1 linked publication.
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 8 Jul 2026.