High Intensity Interval Exercise (HIIE)NCT02270528
Acute Effects of High Intensity Interval Exercise on Executive Function
A study testing Exercise and Cognitive Task in people with High Intensity Interval Exercise (HIIE) and Pain Perception, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- High Intensity Interval Exercise (HIIE), Pain Perception, Wisconsin Card Sorting Task
- What is being tested?
- Exercise and Cognitive Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male college students
- Ages of 18-35 years old
- Body fat percent < 25%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Unit, MCVH-VCU
Richmond, Virginia, 23228
About this study
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.
Read the detailed 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.
- Being tested
- Exercise, Cognitive Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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 TaskBehavioural
The Wisconsin Card Sorting Task (WCST) is a measure of Executive Function.
| Study group | Role | What they receive |
|---|---|---|
| HIT1 | Experimental | This group will participate in the Wisconsin Card Sorting Task (WCST) two times. During the first attempt, prior to the WCST, this group will perform a warm-up and the high intensity interval exercise. The second attempt, prior to the WCST, this group will perform a warm-up and 5-minute stationary period. All measures of independent variables (pH, lactate, RPE, RPP, and FS) will be the same for all groups. Receives: Behavioral: Exercise; Behavioral: Cognitive Task |
| HIT2 | Experimental | This group will participate in the Wisconsin Card Sorting Task (WCST) two times. During the first attempt, prior to the WCST, this group will perform a warm-up and a 5-minute stationary period. The second attempt, prior to the WCST, this group will perform a warm-up and the high intensity interval exercise. All measures of independent variables (pH, lactate, RPE, RPP, and FS) will be the same for all groups. Receives: Behavioral: Exercise; Behavioral: Cognitive Task |
| CON | Other | This group will participate in the Wisconsin Card Sorting Task (WCST) two times. During the first attempt and second attempt, prior to the WCST, this group will participate in a 15-minute stationary period. All measures of independent variables (pH, lactate, RPE, RPP, and FS) will be the same for all groups. Receives: Behavioral: Cognitive Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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 outcomes (3)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Interval Exercise (HIIE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edmund O Acevedo, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270528
- Sponsor's protocol ID
- HM20000451
- Status last verified
- Aug 2018
- First submitted
- 25 Sep 2014
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of High Intensity Interval Exercise on Executive Function
- ClinicalTrials.gov ID
- NCT02270528
- Acronym / sponsor ID
- HM20000451
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIT1 | Experimental | Behavioral: Exercise, Behavioral: Cognitive TaskThis group will participate in the Wisconsin Card Sorting Task (WCST) two times. During the first attempt, prior to the WCST, this group will perform a warm-up and the high intensity interval exercise. The second attempt, prior to the WCST, this group will perform a warm-up and 5-minute stationary period. All measures of independent variables (pH, lactate, RPE, RPP, and FS) will be the same for all groups. |
| HIT2 | Experimental | Behavioral: Exercise, Behavioral: Cognitive TaskThis group will participate in the Wisconsin Card Sorting Task (WCST) two times. During the first attempt, prior to the WCST, this group will perform a warm-up and a 5-minute stationary period. The second attempt, prior to the WCST, this group will perform a warm-up and the high intensity interval exercise. All measures of independent variables (pH, lactate, RPE, RPP, and FS) will be the same for all groups. |
| CON | Other | Behavioral: Cognitive TaskThis group will participate in the Wisconsin Card Sorting Task (WCST) two times. During the first attempt and second attempt, prior to the WCST, this group will participate in a 15-minute stationary period. All measures of independent variables (pH, lactate, RPE, RPP, and FS) will be the same for all groups. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male college students
- Ages of 18-35 years old
- Body fat percent < 25%
Key exclusion criteria (7 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise10 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) | Behavioural | HIT1, HIT2 |
| Cognitive TaskThe Wisconsin Card Sorting Task (WCST) is a measure of Executive Function. | Behavioural | CON, HIT1, HIT2 |
Primary outcome
Peripheral Blood Lactate
Time frame: 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)
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.
Peripheral Hydrogen Ions, Peripheral Blood pH
Time frame: 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)
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.
Executive Function
Time frame: 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)
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.
3 secondary outcomes
Ratings of Perceived Pain (RPP)
Time frame: 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)
Ratings of Perceived Exertion (RPE)
Time frame: 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)
Emotion (Feeling Scale, FS)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund O Acevedo, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cognitive Task in people with High Intensity Interval Exercise (HIIE) and Pain Perception, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Blood Lactate (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.