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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04137939
Enrollment
400
Registered
2019-10-24
Start date
2019-07-15
Completion date
2027-08-31
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Exercise

Brief 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. 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.

Interventions

DEVICEsmart exercise system

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.

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
30 second chair stand testbaselinenumber of full stands that can be completed in 30 seconds with arms folded across chest.

Secondary

MeasureTime frameDescription
BMIbaselineParticipant's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI) .
SMIbaselineSkeletal 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.
Back scratchbaselineBack 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.
Chair sit-&-reach testbaselineFrom 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.
Six-minute walk testbaselineTo walk as much as possible within six minutes and measure the total distance traveled.
2-minute step testbaseline2-minute step test is to complete steps in 2 minutes. Number of full steps completed in 2 minutes is recorded.
8-foot up-&-go testbaseline8-foot up-\&-go test: number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
Single leg balance with eyes open testbaselineParticipant is instructed to stand by one leg with eye open, the number of seconds is recorded.
Hand grip strength testbaselinehand grip strength test is performed by HandGRIP Dynamometer to detect the grip strength
SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)after 12-week interventionRisk 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.
SARC-Fafter 12-week interventionThe 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.
EQ-5D (EuroQol- 5 Dimensions)baselineEQ-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).
QUEST (Questionnaire for satisfaction)after 12-week interventionThe 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

Countries

Taiwan

Contacts

CONTACTLi-Chieh Kuo, Ph. D.
jkkuo@mail.ncku.edu.tw886-62353535
CONTACTChih-Chun Lin, Ph. D.
z9902026@email.ncku.edu.tw886-62757575
STUDY_DIRECTORLi-Chieh Kuo, Ph. D.

National Cheng-Kung University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026