NCT02270528

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

September 25, 2014

Last Update Submit

August 17, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (3)

  • Ratings of Perceived Pain (RPP)

    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)

    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)

    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)

Study Arms (3)

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.

Behavioral: ExerciseBehavioral: 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.

Behavioral: ExerciseBehavioral: 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.

Behavioral: Cognitive Task

Interventions

ExerciseBEHAVIORAL

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)

HIT1HIT2
Cognitive TaskBEHAVIORAL

The Wisconsin Card Sorting Task (WCST) is a measure of Executive Function.

CONHIT1HIT2

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male college students
  • Ages of 18-35 years old
  • Body fat percent \< 25%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit, MCVH-VCU

Richmond, Virginia, 23228, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Edmund O Acevedo, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 21, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations