- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04880057
Agility Training on Executive Function, Dual Task Performance and Brain Activation in Healthy Adults
Effects of Agility Training on Executive Function, Dual Task Performance and Brain Activation in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yanci Liu, Ph.D
- Phone Number: 0233668135
- Email: yanciliu@ntu.edu.tw
Study Locations
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-
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
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Contact:
- Yanci Liu, PHD
- Phone Number: 0233668135
- Email: yanciliu@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- (1) age between 20 to 30 years, and (2) ability to walk 20 meters independently without an assistive device.
Exclusion Criteria:
- (1) overweight (BMI>24), (2) any smoker or alcohol abusers, (3) suffering from chronic diseases that loss of control, (4) Unstable physiological conditions, such as abnormal signs like high blood pressure, headache, dyspnea, fever, etc., (5) any neuromuscular or cardiopulmonary diseases that would influent the exercise performance, and (6) suffering from diseases which exercises are their contraindications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Resistance+Aerobic training group
Resistance+Aerobic training group (RAeT) RAeT includes resistance training (RT) program and aerobic training (AeT) program.
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The RT focuses on lower extremity workout, including leg press, hamstring curls, and calf raises. The participants start with intensity at 12 RM and finished with intensity at 8 RM after 3 weeks. There are 8 repetitions, 2 sets for each action. It will take 15 minutes to complete RT. The AeT is composed by cycling on stationary bikes in the first week, stepping on steppers in 2nd week, and running on treadmills in the last week. Participants are asked to wear a portable heart rate monitor throughout the experiments. They have to maintain their heart rates in 60%-75% of predicted maximal heart rate (moderate intensity exercise), which has been shown to be benefit on cognition[3]. It took the participants 25 minutes to complete AeT.
Other Names:
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Experimental: Agility training group
Agility training
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AT program consists of three parts: technical drills, pattern running and reactive agility training.
There will be nine sessions over 3 weeks and progress the intensity, complexity or velocity every week.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Executive function- N-back task (3-back)
Time Frame: Change from Baseline score at 3 weeks
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N-back task (3-back) is used to measure working memory
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Change from Baseline score at 3 weeks
|
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Executive function- N-back task (3-back)
Time Frame: Change from Baseline score at 7 weeks
|
N-back task (3-back) is used to measure working memory
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Change from Baseline score at 7 weeks
|
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Executive function- Stroop test
Time Frame: Change from Baseline score at 3 weeks
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Stroop test is used to measure the selective attention and conflict resolution.
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Change from Baseline score at 3 weeks
|
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Executive function- Stroop test
Time Frame: Change from Baseline score at 7 weeks
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Stroop test is used to measure the selective attention and conflict resolution.
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Change from Baseline score at 7 weeks
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Executive function- Wisconsin card sort test
Time Frame: Change from Baseline score at 3 weeks
|
Wisconsin card sort test is an easy way to assess the ability of mental set shifting.
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Change from Baseline score at 3 weeks
|
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Executive function- Wisconsin card sort test
Time Frame: Change from Baseline score at 7 weeks
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Wisconsin card sort test is an easy way to assess the ability of mental set shifting.
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Change from Baseline score at 7 weeks
|
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Single walking performance- Walking speed
Time Frame: Change from Baseline cadence at 3 weeks
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The unit is length (cm) per seconds
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Change from Baseline cadence at 3 weeks
|
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Single walking performance- Walking speed
Time Frame: Change from Baseline cadence at 7 weeks
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The unit is length (cm) per seconds
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Change from Baseline cadence at 7 weeks
|
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Single walking performance- Cadence
Time Frame: Change from Baseline cadence at 3 weeks
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The unit is steps per minutes
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Change from Baseline cadence at 3 weeks
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Single walking performance- Cadence
Time Frame: Change from Baseline cadence at 7 weeks
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The unit is steps per minutes
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Change from Baseline cadence at 7 weeks
|
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Single walking performance- Stride length
Time Frame: Change from Baseline cadence at 3 weeks
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The unit is cm
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Change from Baseline cadence at 3 weeks
|
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Single walking performance- Stride length
Time Frame: Change from Baseline cadence at 7 weeks
|
The unit is cm
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Change from Baseline cadence at 7 weeks
|
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Single walking performance- Step duration
Time Frame: Change from Baseline cadence at 3 weeks
|
The unit is seconds
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Change from Baseline cadence at 3 weeks
|
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Single walking performance- Step duration
Time Frame: Change from Baseline cadence at 7 weeks
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The unit is seconds
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Change from Baseline cadence at 7 weeks
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Dual task walking performance- Walking speed
Time Frame: Change from Baseline cadence at 3 weeks
|
The unit is length (cm) per seconds
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Change from Baseline cadence at 3 weeks
|
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Dual task walking performance- Walking speed
Time Frame: Change from Baseline cadence at 7 weeks
|
The unit is length (cm) per seconds
|
Change from Baseline cadence at 7 weeks
|
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Dual task walking performance- Cadence
Time Frame: Change from Baseline cadence at 3 weeks
|
The unit is steps per minutes
|
Change from Baseline cadence at 3 weeks
|
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Dual task walking performance- Cadence
Time Frame: Change from Baseline cadence at 7 weeks
|
The unit is steps per minutes
|
Change from Baseline cadence at 7 weeks
|
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Dual task walking performance- Stride length
Time Frame: Change from Baseline cadence at 3 weeks
|
The unit is cm
|
Change from Baseline cadence at 3 weeks
|
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Dual task walking performance- Stride length
Time Frame: Change from Baseline cadence at 7 weeks
|
The unit is cm
|
Change from Baseline cadence at 7 weeks
|
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Dual task walking performance- Step duration
Time Frame: Change from Baseline cadence at 3 weeks
|
The unit is seconds
|
Change from Baseline cadence at 3 weeks
|
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Dual task walking performance- Step duration
Time Frame: Change from Baseline cadence at 7 weeks
|
The unit is seconds
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Change from Baseline cadence at 7 weeks
|
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Dual task walking performance- the correct rates of arithmetic task
Time Frame: Change from Baseline cadence at 3 weeks
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The participants will be instructed to subtract by 7 serially from a 3-digit number while walking at their fastest speed in dual task walking condition
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Change from Baseline cadence at 3 weeks
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Dual task walking performance- the correct rates of arithmetic task
Time Frame: Change from Baseline cadence at 7 weeks
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The participants will be instructed to subtract by 7 serially from a 3-digit number while walking at their fastest speed in dual task walking condition
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Change from Baseline cadence at 7 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Brain activities over premotor cortex- Executive function
Time Frame: Change from Baseline at 3 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
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Change from Baseline at 3 weeks
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Brain activities over premotor cortex- Executive function
Time Frame: Change from Baseline at 7 weeks
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A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
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Change from Baseline at 7 weeks
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Brain activities over supplementary motor area- Executive function
Time Frame: Change from Baseline at 3 weeks
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A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
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Change from Baseline at 3 weeks
|
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Brain activities over supplementary motor area- Executive function
Time Frame: Change from Baseline at 7 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 7 weeks
|
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Brain activities over primary motor cortex- Executive function
Time Frame: Change from Baseline at 3 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 3 weeks
|
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Brain activities over primary motor cortex- Executive function
Time Frame: Change from Baseline at 7 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
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Change from Baseline at 7 weeks
|
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Brain activities over premotor cortex- Single walking
Time Frame: Change from Baseline at 3 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
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Change from Baseline at 3 weeks
|
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Brain activities over premotor cortex- Single walking
Time Frame: Change from Baseline at 7 weeks
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A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 7 weeks
|
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Brain activities over supplementary motor area- Single walking
Time Frame: Change from Baseline at 3 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 3 weeks
|
|
Brain activities over supplementary motor area- Single walking
Time Frame: Change from Baseline at 7 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 7 weeks
|
|
Brain activities over primary motor cortex - Single walking
Time Frame: Change from Baseline at 3 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 3 weeks
|
|
Brain activities over primary motor cortex - Single walking
Time Frame: Change from Baseline at 7 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 7 weeks
|
|
Brain activities over premotor cortex- Dual task walking
Time Frame: Change from Baseline at 3 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 3 weeks
|
|
Brain activities over premotor cortex- Dual task walking
Time Frame: Change from Baseline at 7 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 7 weeks
|
|
Brain activities over supplementary motor area- Dual task walking
Time Frame: Change from Baseline at 3 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 3 weeks
|
|
Brain activities over supplementary motor area- Dual task walking
Time Frame: Change from Baseline at 7 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 7 weeks
|
|
Brain activities over primary motor cortex - Dual task walking
Time Frame: Change from Baseline at 3 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 3 weeks
|
|
Brain activities over primary motor cortex - Dual task walking
Time Frame: Change from Baseline at 7 weeks
|
A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
|
Change from Baseline at 7 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 202103055RINB
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.
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