- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07772713
The Effect of IoT-based Smart Exercises System in the Senior Adults: Resistance Band Training System
Smart Health Care and Innovative Technology Service Model Plan: Development of Innovative Health Promotion System for Senior Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 resistance band training twice weekly for 12 weeks, with each session lasting approximately 30 minutes.
Participants in the Ctrl group perform resistance band training according to a paper-based exercise guide. Training completion is recorded by the participants using a paper checklist after each training session. The completed checklists are collected and reviewed by the research team at the end of the study to verify adherence to the prescribed exercise program.
Participants in the SE group perform resistance band training using the Resistance Band Training System. Training sessions and exercise completion are recorded by the system.
Physical fitness tests and questionnaires are administered to participants in both groups before and after the 12-week exercise program. Changes in physical fitness and questionnaire outcomes are evaluated between the two groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Li-Chieh Kuo, Ph. D.
- Phone Number: 886-62353535 Ext. 5908
- Email: jkkuo@mail.ncku.edu.tw
Study Contact Backup
- Name: Chih-Chun Lin, Ph. D.
- Phone Number: 886-62757575 Ext. 58420
- Email: z9902026@email.ncku.edu.tw
Study Locations
-
-
Taiwan
-
Tainan, Taiwan, Taiwan, 701
- Recruiting
- National Cheng Kung University
-
Contact:
- Li-Chieh Kuo, Ph. D.
- Phone Number: 886-62353535 Ext. 5908
- Email: jkkuo@mail.ncku.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Participants in the Ctrl group are instructed to perform resistance band training twice weekly for 12 weeks according to a paper-based exercise guide, with each session lasting approximately 30 minutes.
|
Participants in the Ctrl group are instructed to perform resistance band training twice weekly for 12 weeks according to a paper-based exercise guide, with each session lasting approximately 30 minutes.
|
|
Experimental: Smart Exercise group
Participants in the SE group perform resistance band training using the Resistance Band Training System twice weekly for 12 weeks, with each session lasting approximately 30 minutes.
|
Participants in the SE group perform resistance band training using the Resistance Band Training System twice weekly for 12 weeks, with each session lasting approximately 30 minutes.
Training sessions and exercise completion are recorded by the system.
|
What is the study measuring?
Primary Outcome Measures
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Gait speed
Time Frame: baseline
|
Gait speed test is assessed by 4-meter walk test.
|
baseline
|
|
Gait speed
Time Frame: after 12-week intervention
|
Gait speed test is assessed by 4-meter walk test.
|
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
Investigators
- Study Director: Li-Chieh Kuo, Ph. D., National Cheng-Kung University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B-BR-106-072A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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