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

Study Contact Backup

Study Locations

    • 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

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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