- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375888
The Application of an Innovative Reactive Agility Testing System for Assessment in Older Adults With Dynapenia
Before the experiment, the researchers explain the purpose and procedures to the participants. After signing the informed consent form and completing basic personal information, participants perform a 5-minute warm-up. They then practice the test procedure 1-3 times to become familiar with the visual stimuli, followed by a 3-minute rest before the formal experiment.
Body composition and physical performance are assessed using handgrip strength, the five-time sit-to-stand test, and the skeletal muscle mass index.
Fall risk is evaluated using a localized fall risk awareness questionnaire.
Agility is tested using a reaction-based running task. Participants stand in a 1 m × 1 m preparation area, and one of two sensor lights placed 3 meters away lights up randomly. Participants run forward, pass through a photo gate, and touch the light to turn it off. Decision time, movement time, and total time are recorded over 10 trials.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Before the experiment begins, the researchers will first explain the experimental procedures and purpose to the participants. Participants will then complete an informed consent form and provide their basic personal information. After that, participants will perform a 5-minute warm-up exercise.
To familiarize participants with the visual stimuli, they will practice the test procedure one to three times. After the practice session, participants will rest for 3 minutes before the formal experiment begins.
(1) Body Composition and Physical Performance Data
- **Handgrip Strength:** Measured using a handgrip dynamometer. Three trials are performed, and the maximum value is recorded as the handgrip strength.
- **Five-Time Sit-to-Stand Test:** The participant sits on a standard testing chair with the hips and knees flexed at 90 degrees. Without using the hands for assistance, the participant performs five sit-to-stand movements as quickly as possible. The completion time is recorded.
- **Skeletal Muscle Mass Index (SMI):** The participant stands barefoot on the measurement device and holds the hand electrodes to obtain appendicular muscle mass. The appendicular muscle mass is then divided by height squared to calculate the skeletal muscle mass index.
- (2) Fall Risk
Fall risk is assessed using a localized Fall Risk Awareness Scale. A higher score indicates a greater risk of falling and a higher level of fear of falling.
### (3) Agility Test
The participant stands in the preparation area located at the center of the testing field, which measures 1 m × 1 m. One sensor light is placed on each side, each positioned 3 meters away from the preparation area.
After the system is activated, one of the lights will illuminate randomly between 1 and 5 seconds. Once the light turns on, the participant moves forward quickly, passes through a photo gate next to the preparation area, and continues forward until touching the sensor light to turn it off.
The system records:
- **Decision time:** the time from when the light turns on to when the participant passes through the photo gate.
- **Movement time:** the time from passing through the photo gate to touching and turning off the sensor light.
After a total of 10 trials (combined left and right sides), the test ends. Finally, the system calculates the **total time**, which is the sum of the decision time and movement time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Community-dwelling older adults aged 65 years and above
- Able to communicate with the researchers through spoken or written language
- Able to cooperate with all required assessments
Exclusion Criteria:
- Individuals with cognitive impairment
- Individuals who experience chest pain during recent exercise
- Individuals with angina or joint pain
- Individuals with congestive heart failure
- Individuals who have been advised by a physician not to exercise
- Patients with cancer currently receiving chemotherapy or radiotherapy
- Individuals with neuromuscular disorders or musculoskeletal injuries involving the ankle, knee, or hip joints
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Healthy Elderly
Normal muscle mass Normal muscle strength Normal physical performance
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The participant stands in the preparation area located at the center of the testing field, which measures 1 m × 1 m. One sensor light is placed on each side, with each light positioned 3 meters away from the preparation area. After the system is activated, one of the lights will illuminate randomly between 1 and 5 seconds. Once the light turns on, the participant moves forward quickly, passes through a photo gate next to the preparation area, and continues forward until touching the sensor light to turn it off. The system records the time from when the light turns on to when the participant passes through the photo gate, which is defined as the decision time. The time from passing through the photo gate to touching and turning off the sensor light is defined as the movement time. After completing five trials on each side, the test ends. Finally, the system calculates the total time, which is the sum of the decision time and movement time. |
|
Pre sarcopenia
Low muscle mass Normal muscle strength Normal physical performance
|
The participant stands in the preparation area located at the center of the testing field, which measures 1 m × 1 m. One sensor light is placed on each side, with each light positioned 3 meters away from the preparation area. After the system is activated, one of the lights will illuminate randomly between 1 and 5 seconds. Once the light turns on, the participant moves forward quickly, passes through a photo gate next to the preparation area, and continues forward until touching the sensor light to turn it off. The system records the time from when the light turns on to when the participant passes through the photo gate, which is defined as the decision time. The time from passing through the photo gate to touching and turning off the sensor light is defined as the movement time. After completing five trials on each side, the test ends. Finally, the system calculates the total time, which is the sum of the decision time and movement time. |
|
Sarcopenia
Low muscle mass Low muscle strength or low physical performance
|
The participant stands in the preparation area located at the center of the testing field, which measures 1 m × 1 m. One sensor light is placed on each side, with each light positioned 3 meters away from the preparation area. After the system is activated, one of the lights will illuminate randomly between 1 and 5 seconds. Once the light turns on, the participant moves forward quickly, passes through a photo gate next to the preparation area, and continues forward until touching the sensor light to turn it off. The system records the time from when the light turns on to when the participant passes through the photo gate, which is defined as the decision time. The time from passing through the photo gate to touching and turning off the sensor light is defined as the movement time. After completing five trials on each side, the test ends. Finally, the system calculates the total time, which is the sum of the decision time and movement time. |
|
Dynapenia
Normal muscle mass Low muscle strength or low physical performance
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The participant stands in the preparation area located at the center of the testing field, which measures 1 m × 1 m. One sensor light is placed on each side, with each light positioned 3 meters away from the preparation area. After the system is activated, one of the lights will illuminate randomly between 1 and 5 seconds. Once the light turns on, the participant moves forward quickly, passes through a photo gate next to the preparation area, and continues forward until touching the sensor light to turn it off. The system records the time from when the light turns on to when the participant passes through the photo gate, which is defined as the decision time. The time from passing through the photo gate to touching and turning off the sensor light is defined as the movement time. After completing five trials on each side, the test ends. Finally, the system calculates the total time, which is the sum of the decision time and movement time. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decision time
Time Frame: From participant enrollment to the end of testing
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The system records the time from when the light turns on to when the participant passes through the photo gate, which is defined
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From participant enrollment to the end of testing
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movement time
Time Frame: From participant enrollment to the end of testing
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The time from passing through the photo gate to touching and turning off the sensor light
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From participant enrollment to the end of testing
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip Strength
Time Frame: From participant enrollment to the end of testing
|
Measured using a handgrip dynamometer.
Three trials are performed, and the highest value is recorded as handgrip strength.
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From participant enrollment to the end of testing
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Five-Time Sit-to-Stand Test
Time Frame: From participant enrollment to the end of testing
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The participant sits on a standard testing chair with the hips and knees flexed at 90 degrees.
Without using the hands for assistance, the participant performs five sit-to-stand movements as quickly as possible.
The completion time is recorded.
|
From participant enrollment to the end of testing
|
|
Skeletal Muscle Mass Index (SMI)
Time Frame: From participant enrollment to the end of testing
|
The participant stands barefoot on the measurement device and holds the hand electrodes to obtain appendicular muscle mass.
The appendicular muscle mass is then divided by height squared to calculate the skeletal muscle mass index.
|
From participant enrollment to the end of testing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- KMUHIRB-E(I)-20250028 (Other Identifier: Kaohsiung Medical University Chung-Ho Hospital Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Dynapenia
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Kaohsiung Medical UniversityNot yet recruiting
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Université du Québec a MontréalCompletedAging | Dynapenia | Physical Impairment
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Texas Tech University Health Sciences CenterWithdrawnPostmenopausal Women | DynapeniaUnited States
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Dalin Tzu Chi General HospitalBuddhist Dalin Tzu Chi General HospitalNot yet recruitingAbdominal Obesity | Dynapenia
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Duke UniversityDairy Research InstituteCompletedObesity | DynapeniaUnited States
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Federal University of Rio Grande do SulCompletedDynapenia | Functional Disability | Sarcopenia in ElderlyBrazil
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Karolinska InstitutetThe Swedish Research Council; Swedish Research Council for Sport ScienceCompletedSarcopenia | Muscle Strength | Physical Fitness | Dynapenia | Aerobic FitnessSweden
Clinical Trials on Reactive Agility Testing System
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