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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04880057
Other study ID # 202103055RINB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2, 2021
Est. completion date March 31, 2023

Study information

Verified date June 2022
Source National Taiwan University Hospital
Contact Yanci Liu, Ph.D
Phone 0233668135
Email yanciliu@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the effect of agility training on executive function, dual task walking and brain activation in healthy adults. Participants (N=70) will be randomly assigned to resistance+aerobic training group (RAeT) or agility training group (AT). Participants in RAeT (n=35) will receive 15-minute lower extremity workout first and then 25-minute moderate intensity (60-75% predicted maximal heart rate) aerobic training. Participants in AT (n=35) will do the agility exercise program consisting of technical drills, pattern running and reactive agility training. The intervention will be twelve-time group intervention (3-5persons) in four weeks, 50 minutes per session (5-minute warmup, 40- minute main training, 5-minute cool-down). Participants will undergo three measurement time points (pre-, post-intervention and one month follow-up). Outcome measures will include executive function (N-back test, stroop test and Wisconsin card sort test), single and dual task walking performance and brain activity (fNIRS on prefrontal cortex, supplementary motor area and premotor cortex). Two-way analysis of variance (ANOVA) with Tukey post-hoc test will be used to examine the group x time interaction on three outcome measures.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date March 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Resistance+Aerobic training
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.
Agility training
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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Executive function- N-back task (3-back) N-back task (3-back) is used to measure working memory Change from Baseline score at 3 weeks
Primary Executive function- N-back task (3-back) N-back task (3-back) is used to measure working memory Change from Baseline score at 7 weeks
Primary Executive function- Stroop test Stroop test is used to measure the selective attention and conflict resolution. Change from Baseline score at 3 weeks
Primary Executive function- Stroop test Stroop test is used to measure the selective attention and conflict resolution. Change from Baseline score at 7 weeks
Primary Executive function- Wisconsin card sort test Wisconsin card sort test is an easy way to assess the ability of mental set shifting. Change from Baseline score at 3 weeks
Primary Executive function- Wisconsin card sort test Wisconsin card sort test is an easy way to assess the ability of mental set shifting. Change from Baseline score at 7 weeks
Primary Single walking performance- Walking speed The unit is length (cm) per seconds Change from Baseline cadence at 3 weeks
Primary Single walking performance- Walking speed The unit is length (cm) per seconds Change from Baseline cadence at 7 weeks
Primary Single walking performance- Cadence The unit is steps per minutes Change from Baseline cadence at 3 weeks
Primary Single walking performance- Cadence The unit is steps per minutes Change from Baseline cadence at 7 weeks
Primary Single walking performance- Stride length The unit is cm Change from Baseline cadence at 3 weeks
Primary Single walking performance- Stride length The unit is cm Change from Baseline cadence at 7 weeks
Primary Single walking performance- Step duration The unit is seconds Change from Baseline cadence at 3 weeks
Primary Single walking performance- Step duration The unit is seconds Change from Baseline cadence at 7 weeks
Primary Dual task walking performance- Walking speed The unit is length (cm) per seconds Change from Baseline cadence at 3 weeks
Primary Dual task walking performance- Walking speed The unit is length (cm) per seconds Change from Baseline cadence at 7 weeks
Primary Dual task walking performance- Cadence The unit is steps per minutes Change from Baseline cadence at 3 weeks
Primary Dual task walking performance- Cadence The unit is steps per minutes Change from Baseline cadence at 7 weeks
Primary Dual task walking performance- Stride length The unit is cm Change from Baseline cadence at 3 weeks
Primary Dual task walking performance- Stride length The unit is cm Change from Baseline cadence at 7 weeks
Primary Dual task walking performance- Step duration The unit is seconds Change from Baseline cadence at 3 weeks
Primary Dual task walking performance- Step duration The unit is seconds Change from Baseline cadence at 7 weeks
Primary Dual task walking performance- the correct rates of arithmetic task 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 Change from Baseline cadence at 3 weeks
Primary Dual task walking performance- the correct rates of arithmetic task 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 Change from Baseline cadence at 7 weeks
Secondary Brain activities over premotor cortex- Executive function 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
Secondary Brain activities over premotor cortex- Executive function 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
Secondary Brain activities over supplementary motor area- Executive function 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
Secondary Brain activities over supplementary motor area- Executive function 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
Secondary Brain activities over primary motor cortex- Executive function 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
Secondary Brain activities over primary motor cortex- Executive function 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
Secondary Brain activities over premotor cortex- Single walking 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
Secondary Brain activities over premotor cortex- Single walking 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
Secondary Brain activities over supplementary motor area- Single walking 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
Secondary Brain activities over supplementary motor area- Single walking 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
Secondary Brain activities over primary motor cortex - Single walking 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
Secondary Brain activities over primary motor cortex - Single walking 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
Secondary Brain activities over premotor cortex- Dual task walking 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
Secondary Brain activities over premotor cortex- Dual task walking 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
Secondary Brain activities over supplementary motor area- Dual task walking 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
Secondary Brain activities over supplementary motor area- Dual task walking 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
Secondary Brain activities over primary motor cortex - Dual task walking 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
Secondary Brain activities over primary motor cortex - Dual task walking 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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