The Effect of IoT-based Smart Exercises System in the Senior Adults: Coordination

August 14, 2026 updated by: Li-Chieh Kuo, 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. Participants in the Ctrl group are instructed to perform combined muscle strength and coordination exercises twice weekly, with each session lasting 30 minutes, following an exercise guide recommended by a physical therapist. Participants in the SE group perform combined muscle strength and coordination training using the Smart Exercise System twice weekly, with each session lasting 30 minutes, for 12 weeks. Physical fitness tests, coordination tests, and questionnaires are administered to participants in both groups before and after the 12-week exercise program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants are divided into two groups: (1) the Control (Ctrl) group and (2) the Smart Exercise (SE) group. Participants in both groups are instructed to perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes.

Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.

Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system. The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE). Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.

Physical fitness tests, coordination tests, and questionnaires are administered to participants in both groups before and after the 12-week exercise program. Changes in physical fitness, coordination, and questionnaire outcomes are compared between the two groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
    • Taiwan
      • Tainan, Taiwan, Taiwan, 701
        • Recruiting
        • National Cheng-Kung University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • 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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.
Behavioral: Exercises
Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.
Experimental: Smart Exercise group
Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system. The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE). Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.
Device: Smart Exercise program
Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system. The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE). Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
TUG Manual
Time Frame: baseline
The TUG Manual Test evaluates a senior's attentional control and dynamic balance under a motor dual-task condition. Participants perform the standard Timed Up and Go task-standing, walking three meters, turning, and sitting-while carrying a full glass of water in one hand. Instructors record the time, with scores over 14.5 seconds indicating a high risk of falling.
baseline
TUG Manual
Time Frame: after 12-week intervation
The TUG Manual Test evaluates a senior's attentional control and dynamic balance under a motor dual-task condition. Participants perform the standard Timed Up and Go task-standing, walking three meters, turning, and sitting-while carrying a full glass of water in one hand. Instructors record the time, with scores over 14.5 seconds indicating a high risk of falling.
after 12-week intervation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
BMI
Time Frame: basline
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
basline
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).
after 12-week intervention
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.
baseline
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.
after 12-week intervention
30 second chair stand test
Time Frame: baseline
Number of full stands that can 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 30 seconds with arms folded across chest.
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 TANITA MC-780MA body composition analyzer.
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 TANITA MC-780MA body composition analyzer.
after 12-week intervention
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.
baseline
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.
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
Hand grip strength test
Time Frame: baseline
Hand grip strength test is performed by HandGRIP Dynamometer
baseline
Hand grip strength test
Time Frame: after 12-week intervention
Hand grip strength test is performed by HandGRIP Dynamometer
after 12-week intervention
Extremity strength
Time Frame: baseline
Extremity strength test is performed by handheld dynamometer
baseline
Extremity strength
Time Frame: after 12-week intervention
Extremity strength test is performed by handheld dynamometer
after 12-week intervention
Soda pop coordination
Time Frame: baseline
The Soda Pop Coordination Test assesses manual dexterity and hand-eye coordination. Participants use their dominant hand to flip and reposition three soda cans across six marked points as quickly as possible. Completion time is recorded.
baseline
Soda pop coordination
Time Frame: after 12-week intervention
The Soda Pop Coordination Test assesses manual dexterity and hand-eye coordination. Participants use their dominant hand to flip and reposition three soda cans across six marked points as quickly as possible. Completion time is recorded.
after 12-week intervention
Ruler drop test
Time Frame: baseline
The Ruler Drop Test assesses visual reaction time and hand-eye coordination. Participants catch a ruler dropped without warning using their dominant hand. The falling distance is recorded to calculate reaction time in milliseconds.
baseline
Ruler drop test
Time Frame: after 12-week intervation
The Ruler Drop Test assesses visual reaction time and hand-eye coordination. Participants catch a ruler dropped without warning using their dominant hand. The falling distance is recorded to calculate reaction time in milliseconds.
after 12-week intervation
Box and blocks test
Time Frame: baseline
The Box and Block Test assesses gross manual dexterity and upper-extremity function. Participants transfer blocks across a partition using one hand at a time. The number of blocks transferred within one minute is recorded.
baseline
Box and blocks test
Time Frame: after 12-week intervation
The Box and Block Test assesses gross manual dexterity and upper-extremity function. Participants transfer blocks across a partition using one hand at a time. The number of blocks transferred within one minute is recorded.
after 12-week intervation
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
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.
after 12-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Li-Chieh Kuo, Ph. D., National Cheng-Kung University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-BR-106-072B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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