Clinical trial NCT04137939: The Effect of IoT-based Smart Exercises System in the Senior Adults
Official title: Smart Health Care and Innovative Technology Service Model Plan : Development of Innovative Health Promotion System for Senior Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly Exercise
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 30 second chair stand test
timeFrame: baseline
measure: 30 second chair stand test
timeFrame: after 12-week intervention
Secondary outcomes:
measure: BMI
timeFrame: baseline
measure: BMI
timeFrame: after 12-week intervention
measure: SMI
timeFrame: baseline
measure: SMI
timeFrame: after 12-week intervention
measure: Back scratch
timeFrame: baseline
measure: Back scratch
timeFrame: after 12-week intervention
measure: Chair sit-&-reach test
timeFrame: baseline
measure: Chair sit-&-reach test
timeFrame: after 12-week intervention
measure: Six-minute walk test
timeFrame: baseline
measure: Six-minute walk test
timeFrame: after 12-week intervention
measure: 2-minute step test
timeFrame: baseline
measure: 2-minute step test
timeFrame: after 12-week intervention
measure: 8-foot up-&-go test
timeFrame: baseline
measure: 8-foot up-&-go test
timeFrame: after 12-week intervention
measure: Single leg balance with eyes open test
timeFrame: baseline
measure: Single leg balance with eyes open test
timeFrame: after 12-week intervention
measure: Hand grip strength test
timeFrame: baseline
measure: Hand grip strength test
timeFrame: after 12-week intervention
measure: SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)
timeFrame: after 12-week intervention
measure: SOF (Study of Osteoporotic Fractures) frailty index (Questionnaire for physical function and health status)
timeFrame: baseline
measure: SARC-F
timeFrame: after 12-week intervention
measure: SARC-F
timeFrame: baseline
measure: EQ-5D (EuroQol- 5 Dimensions)
timeFrame: baseline
measure: EQ-5D (EuroQol- 5 Dimensions)
timeFrame: after 12-week intervention
measure: QUEST (Questionnaire for satisfaction)
timeFrame: after 12-week intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Li-Chieh Kuo, Ph. D.
role: STUDY_DIRECTOR
References: