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NCT Number: NCT04137939

The Effect of IoT-based Smart Exercises System in the 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.

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Key information

Conditions

Elderly Exercise

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University

Tainan, Taiwan, 701

Location status: Recruiting

Location contact

Li-Chieh Kuo, Ph. D.

CONTACT

[email protected]

886-62353535 ext. 5908

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smart exercise system

Device

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.

Primary outcomes

  1. 30 second chair stand test

    Time frame: baseline

    number of full stands that can be completed in 30 seconds with arms folded across chest.

  2. 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.

Secondary outcomes

  1. BMI

    Time frame: baseline

    Participant's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI) .

  2. 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) .

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Six-minute walk test

    Time frame: baseline

    To walk as much as possible within six minutes and measure the total distance traveled.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Hand grip strength test

    Time frame: baseline

    hand grip strength test is performed by HandGRIP Dynamometer to detect the grip strength

  18. Hand grip strength test

    Time frame: after 12-week intervention

    hand grip strength test is performed by HandGRIP Dynamometer to detect the grip strength

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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).

  24. 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).

  25. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Chun Lin, Ph. D.

CONTACT

[email protected]

886-62757575 ext. 58420

Li-Chieh Kuo, Ph. D.

CONTACT

[email protected]

886-62353535 ext. 5908

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Smart Health Care and Innovative Technology Service Model Plan : Development of Innovative Health Promotion System for Senior Adults

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2019
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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