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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02270528
Other study ID # HM20000451
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date July 2018

Study information

Verified date August 2018
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine the acute effects of high intensity interval ergometry on peripheral concentrations of lactate and hydrogen ions, as well as cognitive function. Approximately 60 healthy, college-aged males will participate in the Wisconsin Card Sorting Task (WCST), a measure of executive function, two times over a span of two weeks. Prior to the WCST, participants will complete either a warm-up, a warm-up and high intensity interval exercise, or a stationary period. Changes in lactate, pH, and WCST score will be evaluated between and within groups in relation to the presence of the high intensity exercise stimulus.


Description:

The experimental protocol will be performed in three groups. Two of the three groups (HIT1 and HIT2) will counterbalance one another, meaning these participants will each receive the same level of treatment, but the treatments will occur in different sequence. The third group will serve as the control (CON). All qualified subjects will complete a consent form after receiving a detailed explanation of the experimental purpose and procedure by the investigator. Subjects qualify to participate in this study based upon the results of the preliminary health history record, ACSM risk assessment, and a 7-day activity recall form IPAQ. Following consent, participants will be randomized into one of three groups and will be scheduled three(3) lab sessions. A Subject Tracking Form will be used to monitor the progress of each subject.

All three groups begin the study with the same session protocol, constituting Day 1 (Baseline). This session will include baseline measurements of perceived effort (RPE), perceived pain (RPP), and affect (FS). These measures will be taken before and after the maximal oxygen uptake test scheduled on this day. Two single 15 mL blood samples (~1 tablespoon) will be drawn for baseline pH and lactate quantification. Blood draws (BD) are repeated for a total of 8 times throughout the study for a total of 120 mL of blood. During the two experimental sessions (Session 2 and Session 3) blood will be drawn 3 times each; prior to HIT or seated rest, immediately following HIT or seated rest, and following the Wisconsin Card Sorting Task (WCST). The seventh and eight blood draws will occur during baseline, immediately before and after the maximal oxygen uptake exercise test. Each group will participate in all 8 blood draws. A demonstration of the WCST and a review of the Tabata high-intensity interval training protocol (HIT) will also be given during this session. Session 1 includes a cardiovascular fitness assessment (relative VO2 test) and body fat assessment (Bioelectrical Impedence Analysis, or BIA).

The following two sessions, Day 3 (Session 2) and Day 17 (Session 3), will be different for each group. The first group, (HIT1), will complete a warm-up, HIT, and the WCST during Session 2. The next session, Session 3, will be scheduled no less than 14 days from Session 2 and includes a warm-up, a 5-minute stationary period, and the WCST. The second group, (HIT2), will complete the same protocols as HIT1, but will complete Session 2 and Session 3 in reverse order. The control group (CON) will not perform the warm-up or the HIT exercise before either WCST. This group will still have 14-days separating WCST attempts. A follow-up by email will be used to report the results of the WCST scores to each participant once all subjects have completed the study in its entirety. Instructions on how to receive compensation for participating in the study will also be provided in the follow-up.

Data will be analyzed using the current version of SPSS Statistics. A 2 (HIT, no HIT) x 3 (pre-, immediately post-, and delayed post- HIT) repeated measures ANOVA will be used to determine the affects of HIT on biophysiological functions (La, H+, RPP, RPE, and FS). A paired t-test will show changes in executive function due to HIT. A Pearson correlation will determine the influence of biophysiological factors on cognitive function and a 3 (HIT1, HIT2, CON) x 2 (time of WCST) mixed-model ANOVA will demonstrate the learning effects associated with the WCST over a 14-day period.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Healthy male college students

- Ages of 18-35 years old

- Body fat percent < 25%

Exclusion Criteria:

- Moderate to high risk for cardiovascular disease

- Reporting any known physical or psychological diseases or disorders

- Participating in certain prescription and/or illegal drug use

- Smoking

- Body fat percent > 25%

- Those having undergone any surgery, serious injury, or hospitalization within the past five years

- Those having experienced a major life event (eg divorce, family death) in the past five years

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
10 seconds of sprinting on a bicycle ergometer against a resistance equivalent to 5.5% of a participant's body weight, followed by 20 seconds of rest, repeated 10 times. (~5 minutes)
Cognitive Task
The Wisconsin Card Sorting Task (WCST) is a measure of Executive Function.

Locations

Country Name City State
United States Clinical Research Unit, MCVH-VCU Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peripheral Blood Lactate Lactate is known to increase during exercise. At each time frame, ~15mL of blood will be sampled from a subject via intravenous catheter. From this sample, blood will be analyzed for lactate using a YSI2300. 8 times total; 2 at Baseline (Day 1; Minute 14 and Minute 29), 3 in session 1 (Day 3; Minute 2, Minute 18, and Minute 29), and 3 in session 2 (Day 17; Minute 2, Minute 18, and Minute 29); Maximum Time Frame at Session 2 (Day 17, Minute 29)
Primary Peripheral Hydrogen Ions, Peripheral Blood pH pH decreases during rigorous or intense exercise. At each time frame, ~15mL of blood will be sampled from a subject via intravenous catheter. From this sample, blood will be analyzed for Hydrogen Ions (pH) via a pH electrode. 8 times total; 2 at Baseline (Day 1; Minute 14 and Minute 29), 3 in session 1 (Day 3; Minute 2, Minute 18, and Minute 29), and 3 in session 2 (Day 17; Minute 2, Minute 18, and Minute 29); Maximum Time Frame at Session 2 (Day 17, Minute 29)
Primary Executive Function Executive Function deals with the ability to problem solve, plan, and make decisions. The Wisconsin Card Sorting Task (WCST) is a computerized version of a task of executive function. Categories completed will be used as the measure of executive function ability. 2 times total, 1 in session 1 (Day 3; Minute 20), 1 in session 2 (Day 17, Minute 20); Maximum Time Frame at Session 2 (Day 17, Minute 20)
Secondary Ratings of Perceived Pain (RPP) This is a visual analog scale used to determine an individual's relative perceived level of pain. The individual will mark on the scale how much pain they are experiencing. 8 times total; 2 at Baseline (Day 1; Minute 15 and Minute 30), 3 in session 1 (Day 3; Minute 3, Minute 19, and Minute 30), and 3 in session 2 (Day 17; Minute 3, Minute 19, and Minute 30); Maximum Time Frame at Session 2 (Day 17, Minute 30)
Secondary Ratings of Perceived Exertion (RPE) RPE will be measured using Borg's scale of exertion. This is a numeric scale (6-20). An individual will state the number that correlates to the level of effort being given. 8 times total; 2 at Baseline (Day 1; Minute 15 and Minute 30), 3 in session 1 (Day 3; Minute 3, Minute 19, and Minute 30), and 3 in session 2 (Day 17; Minute 3, Minute 19, and Minute 30); Maximum Time Frame at Session 2 (Day 17, Minute 30)
Secondary Emotion (Feeling Scale, FS) This is a numeric scale (-5 to +5). An individual will state the number that correlates to the emotion being felt (-5= Very Bad to +5+Very Good). 8 times total; 2 at Baseline (Day 1; Minute 15 and Minute 30), 3 in session 1 (Day 3; Minute 3, Minute 19, and Minute 30), and 3 in session 2 (Day 17; Minute 3, Minute 19, and Minute 30); Maximum Time Frame at Session 2 (Day 17, Minute 30)
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