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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05311202
Other study ID # PACNL_202201HM012
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source National Taiwan Normal University
Contact Yu-Kai Chang, Ph.D
Phone +886277493220
Email yukaichangnew@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current study is a five-arm, single bout program aiming to assess the effects of training volume and intensity of acute resistance exercise on inhibitory control on neurocognitive function with respect to event-related potential in adults aged 20 - 26 years.


Description:

The current study is expected that 175 healthy adults will be recruited and randomly assigned to control group, low volume-moderate intensity, moderate volume-moderate intensity, high volume-moderate intensity, or moderate volume-low intensity group, with 35 participants in each group. Participants will be required to conduct two experiments. The first was the familiarity experiment, which consisted of the experiment description, the familiarity test, and the 6 Repetition Maximum (RM) test. The process lasted about 3 hours. The exercise group was given a warm-up exercise before the intervention, followed by resistance exercise, including Bench Press, Rowing, Deadlift, and Squat, all completed on the Smith machine. After the exercise, the group was given a cool down, while the control group was given 30 minutes of reading. Before and after the intervention, Stroop, event-related potential and fingertip blood lactate were measured, and another fingertip blood lactate was measured 10 minutes after the intervention, which lasted about 3 hours.


Recruitment information / eligibility

Status Recruiting
Enrollment 175
Est. completion date December 31, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 26 Years
Eligibility Inclusion Criteria: - The dominant hand is right-handed - 18.5 < BMI < 26 - Can cooperate with fingertip blood collection - No color blindness and epilepsy - Not taking medications that affect brain function - Irregular exercise (more than 150 minutes per week for 3 months) Exclusion Criteria: - The participants who do not meet the inclusion or The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) Criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
low-volume moderate-intensity group
The interventional program will include (1) 5 minutes of warm-up and aerobic exercise from light to moderate intensity; (2) 20 minutes of two sets of moderate intensity resistance exercise with 10 repetitions; (3) 5 minutes of cool down
moderate-volume moderate-intensity group
The interventional program will include (1) 5 minutes of warm-up and aerobic exercise from light to moderate intensity; (2) 30 minutes of three sets of moderate intensity resistance exercise with 10 repetitions; (3) 5 minutes of cool down
high-volume moderate-intensity group
The interventional program will include (1) 5 minutes of warm-up and aerobic exercise from light to moderate intensity; (2) 40 minutes of four sets of moderate intensity resistance exercise with 10 repetitions; (3) 5 minutes of cool down
moderate-volume low-intensity group
The interventional program will include (1) 5 minutes of warm-up and aerobic exercise from light to moderate intensity; (2) 35 minutes of four sets of low intensity resistance exercise with 20 repetitions; (3) 5 minutes of cool down
Control group
Reading a book related to cognitive function & exercise for 40 minutes

Locations

Country Name City State
Taiwan National Taiwan Normal University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes In Inhibitory Control The computerized Stroop test will be administrated to assess participants' inhibitory function, and the changes in Emotional Stroop test performance (i.e., response time and accuracy) before (pre-test) and after (post-test) intervention will be examined. 30 minutes each before & after intervention
Primary Changes In Neuroelectrical Activities: Event-Related Potential Recording and Analysis The continuous electroencephalogram (EEG) activity of each participant will be recorded throughout the entire Stroop task using a Neuroscan Quick-Cap, with 32 Ag/AgCl electrodes arranged following the international 10-20 system (NeuroScan Inc., El Paso, TX, USA). Changes in the neuroelectrical activities before and after the intervention will be examined. The time windows for each ERP component will be determined based on a visual inspection of the averaged grand waveform. 30 minutes each before & after intervention
Secondary Changes In Positive & Negative Affect The changes in the Positive & Negative affect after pre-and post-test will be assessed by The Positive and Negative Affect Schedule (PANAS) questionnaire, which is made up of two 10-item scales that assess both positive and negative emotions. Each item is scored on a scale of 1 (not at all) to 5 (very much). 5 minutes after pre-test and post-test of Stroop test
Secondary Muscular Fitness Measurements (1RM)-Deadlift The greatest weight an individual is capable of lifting for one repetition (1RM) will be examined using the 6-RM assessment according to the American College of Sports Medicine (ACSM) protocol. There were multiple steps in the resistance exercise assessment process. Warming up at a low intensity for 1 minute will be followed by a 1-minute rest break. For the first set of exercises, each person's workload (lbs) will be increased by 10-20% for lower body exercises. Participants will be told to do 10 repetitions followed by a 2-minute rest break during this step. Following that, a steadily increasing load will be applied until the load can only be completed less than 6 repetitions. The numbers of set will be limited to the minimum 1set to maximum 4sets. The 1RM will be caculated by the results of 6-RM protocol. 2 hours on the first day
Secondary Muscular Fitness Measurements (1RM)-Bench Press The greatest weight an individual is capable of lifting for one repetition (1RM) will be examined using the 6-RM assessment according to the American College of Sports Medicine (ACSM) protocol. There were multiple steps in the resistance exercise assessment process. Warming up at a low intensity for 1 minute will be followed by a 1-minute rest break. For the first set of exercises, each person's workload (lbs) will be increased by 5-10%. Participants will be told to do 10 repetitions followed by a 2-minute rest break during this step. Following that, a steadily increasing load will be applied until the load can only be completed less than 6 repetitions. The numbers of set will be limited to the minimum 1set to maximum 4sets. 1RM will be caculated by the results of 6-RM protocol. 2 hours on the first day
Secondary Muscular Fitness Measurements (1RM)-Squat The greatest weight an individual is capable of lifting for one repetition (1RM) will be examined using the 6-RM assessment according to the American College of Sports Medicine (ACSM) protocol. There were multiple steps in the resistance exercise assessment process. Warming up at a low intensity for 1 minute will be followed by a 1-minute rest break. For the first set of exercises, each person's workload (lbs) will be increased by 10-20% for. Participants will be told to do 10 repetitions followed by a 2-minute rest break during this step. Following that, a steadily increasing load will be applied until the load can only be completed less than 6 repetitions. The numbers of set will be limited to the minimum 1set to maximum 4sets. 1RM will be caculated by the results of 6-RM protocol. 2 hours on the first day
Secondary Muscular Fitness Measurements (1RM)-Rowing The greatest weight an individual is capable of lifting for one repetition (1RM) will be examined using the 6-RM assessment according to the American College of Sports Medicine (ACSM) protocol. There were multiple steps in the resistance exercise assessment process. Warming up at a low intensity for 1 minute will be followed by a 1-minute rest break. For the first set of exercises, each person's workload (lbs) will be increased by 5-10%. Participants will be told to do 10 repetitions followed by a 2-minute rest break during this step. Following that, a steadily increasing load will be applied until the load can only be completed less than 6 repetitions. The numbers of set will be limited to the minimum 1set to maximum 4sets. 1RM will be caculated by the results of 6-RM protocol. 2 hours on the first day
Secondary Changes In Concentration Of Blood Lactate Fingertip Blood samples will be collected using Lactate Analyzer in three times point: before the pre-test of cognitive test, after the intervention and before the post-test of cognitive test, and analysed the change in concentration of blood lactate between the three time points. 2 minutes of each time point (Before the pre-test of cognitive test, after the intervention and before the post-test of cognitive test)
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