- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137939
The Effect of IoT-based Smart Exercises System in the Senior Adults
December 17, 2025 updated by: National Cheng-Kung University Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 exercise, heart rate of user and revolutions per minute (RPM) of the ergometer is detected per second.
After each session of exercise, the rating of perceived exertion (RPE) of user is also inquired and recorded.
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li-Chieh Kuo, Ph. D.
- Phone Number: 5908 886-62353535
- Email: jkkuo@mail.ncku.edu.tw
Study Contact Backup
- Name: Chih-Chun Lin, Ph. D.
- Phone Number: 58420 886-62757575
- Email: z9902026@email.ncku.edu.tw
Study Locations
-
-
Taiwan
-
Tainan, Taiwan, Taiwan, 701
- Recruiting
- National Cheng-Kung University
-
Contact:
- Li-Chieh Kuo, Ph. D.
- Phone Number: 5908 886-62353535
- Email: jkkuo@mail.ncku.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Ctrl group is instructed to maintain their original daily life
|
|
|
Experimental: Smart Exercise group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30 second chair stand test
Time Frame: baseline
|
number of full stands that can be completed in 30 seconds with arms folded across chest.
|
baseline
|
|
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.
|
after 12-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: baseline
|
Participant's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI) .
|
baseline
|
|
BMI
Time Frame: after 12-week intervention
|
Participant's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI) .
|
after 12-week intervention
|
|
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 bioelectrical impedance analysis.
|
baseline
|
|
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 bioelectrical impedance analysis.
|
after 12-week intervention
|
|
Back scratch
Time Frame: baseline
|
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.
|
baseline
|
|
Back scratch
Time Frame: after 12-week intervention
|
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.
|
after 12-week intervention
|
|
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.
|
baseline
|
|
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.
|
after 12-week intervention
|
|
Six-minute walk test
Time Frame: baseline
|
To walk as much as possible within six minutes and measure the total distance traveled.
|
baseline
|
|
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.
|
after 12-week intervention
|
|
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.
|
baseline
|
|
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.
|
after 12-week intervention
|
|
8-foot up-&-go test
Time Frame: baseline
|
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.
|
baseline
|
|
8-foot up-&-go test
Time Frame: after 12-week intervention
|
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.
|
after 12-week intervention
|
|
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.
|
baseline
|
|
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.
|
after 12-week intervention
|
|
Hand grip strength test
Time Frame: baseline
|
hand grip strength test is performed by HandGRIP Dynamometer to detect the grip strength
|
baseline
|
|
Hand grip strength test
Time Frame: after 12-week intervention
|
hand grip strength test is performed by HandGRIP Dynamometer to detect the grip strength
|
after 12-week intervention
|
|
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.
|
baseline
|
|
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.
|
after 12-week intervention
|
|
SARC-F
Time Frame: baseline
|
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.
|
baseline
|
|
SARC-F
Time Frame: after 12-week intervention
|
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.
|
after 12-week intervention
|
|
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).
|
baseline
|
|
EQ-5D (EuroQol- 5 Dimensions)
Time Frame: after 12-week intervention
|
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).
|
after 12-week intervention
|
|
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
|
after 12-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Li-Chieh Kuo, Ph. D., National Cheng-Kung University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2019
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Study Registration Dates
First Submitted
September 11, 2019
First Submitted That Met QC Criteria
October 22, 2019
First Posted (Actual)
October 24, 2019
Study Record Updates
Last Update Posted (Estimated)
December 24, 2025
Last Update Submitted That Met QC Criteria
December 17, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- B-BR-106-072
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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