- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499977
Acute Cycling on Executive Control (ACE)
June 19, 2018 updated by: Dr. Harry Prapavessis, Western University, Canada
The Effects of Acute Cycling on Executive Control
This study will examine whether 10-minute bouts of cycling at various intensities will impact executive functioning (i.e., cognitive ability) as assessed by the antisaccade (AS) task through a total of five visits.
An antisaccade is a rapid eye movement away from a visual target.
The ability to suppress making an eye movement towards a visual target gauges inhibitory control (i.e., a domain of executive functioning).
In the initial visit, participants' exercise capacity will be assessed through a maximal effort cycling test.
Intensities for the cycling bouts (i.e., high, moderate, low) in subsequent sessions will be based upon this maximal effort cycling test.
In visits 2 through 5, participants will complete an AS task, followed by a 10-minute bout of cycling, and then complete the AS task again.
The order of cycling intensities will be randomized between participants.
Differences in the AS task (i.e., reaction time and accuracy) will be compared between and within cycling conditions.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Harry Prapavessis, Ph.D
- Phone Number: 80173 5196612111
- Email: hprapave@uwo.ca
Study Contact Backup
- Name: Kirsten B Dillon, B.Sc
- Phone Number: 6043566359
- Email: kdillon9@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A3K7
- Western University
-
Contact:
- Harry Prapavessis, Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to read, write and understand English
- Full time student enrolled at Western University
- Able to perform a ten-minute exercise task at a light intensity without health implications
- Have email or phone number for contacting purposes
Exclusion Criteria:
- Do not have a medical condition that prevents you from exercise (e.g. heart attack in the past year, heart disease, irregular heartbeat, etc.)
- Do not have history of eye injury or neurological impairment
- Do not have an orthopaedic limitation
- Are not pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sitting
The participant will be asked to sit for 10 min (not increasing their heart rate) then do the anti-saccade task
|
10 min bouts
|
EXPERIMENTAL: Low-Intensity Cycling
Participant will be asked to cycle for 10 min (<40% VO2R) and then perform the anti-saccade task
|
10min bout
|
EXPERIMENTAL: Moderate-Intensity Cycling
The participant will be asked to do 10 min of cycling (40-59% VO2R) followed but the anti-saccade task
|
10 min bout
|
EXPERIMENTAL: High-Intensity Cycling
The participant will be asked to do 10 min of cycling (60%-84% VO2R) followed but the anti-saccade task
|
10 min bout
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction Time
Time Frame: 30 minutes
|
Time in milliseconds to target
|
30 minutes
|
Accuracy
Time Frame: 30 minutes
|
Directional errors
|
30 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate
Time Frame: 10 minutes
|
Heart rate measured in beats per minute with a Polar Heart Rate Monitor as a manipulation check
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2018
Primary Completion (ANTICIPATED)
December 31, 2018
Study Completion (ANTICIPATED)
July 31, 2019
Study Registration Dates
First Submitted
April 9, 2018
First Submitted That Met QC Criteria
April 9, 2018
First Posted (ACTUAL)
April 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2018
Last Update Submitted That Met QC Criteria
June 19, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- PA and Executive Functioning
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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