Physical ActivityACENCT03499977
Acute Cycling on Executive Control
A study testing Sitting, Light-Intensity Cycling and Moderate-Intensity Cycling in people with Physical Activity, run by Western University, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Sitting, Light-Intensity Cycling and Moderate-Intensity Cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2018to 31 Jul 2019
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Physical Activity
- Being tested
- Sitting, Light-Intensity Cycling, Moderate-Intensity Cycling, High-Intensity Cycling
- Keywords
- Physical Activity, Executive function, Anti-saccade
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SittingBehavioural
10 min bouts
Light-Intensity CyclingBehavioural
10min bout
Moderate-Intensity CyclingBehavioural
10 min bout
High-Intensity CyclingBehavioural
10 min bout
| Study group | Role | What they receive |
|---|---|---|
| Sitting | Experimental | The participant will be asked to sit for 10 min (not increasing their heart rate) then do the anti-saccade task Receives: Behavioral: Sitting |
| Low-Intensity Cycling | Experimental | Participant will be asked to cycle for 10 min (<40% VO2R) and then perform the anti-saccade task Receives: Behavioral: Light-Intensity Cycling |
| Moderate-Intensity Cycling | Experimental | The participant will be asked to do 10 min of cycling (40-59% VO2R) followed but the anti-saccade task Receives: Behavioral: Moderate-Intensity Cycling |
| High-Intensity Cycling | Experimental | The participant will be asked to do 10 min of cycling (60%-84% VO2R) followed but the anti-saccade task Receives: Behavioral: High-Intensity Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Time
Time in milliseconds to target
Measured: 30 minutes
Accuracy
Directional errors
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Harry Prapavessis, Western University, Canada
- Investigators
- Harry Prapavessis, Ph.D, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499977
- Sponsor's protocol ID
- PA and Executive Functioning
- Acronym
- ACE
- Status last verified
- May 2024
- First submitted
- 9 Apr 2018
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Cycling on Executive Control
- ClinicalTrials.gov ID
- NCT03499977
- Acronym / sponsor ID
- ACE / PA and Executive Functioning
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Executive function, Anti-saccade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- 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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sitting | Experimental | Behavioral: SittingThe participant will be asked to sit for 10 min (not increasing their heart rate) then do the anti-saccade task |
| Low-Intensity Cycling | Experimental | Behavioral: Light-Intensity CyclingParticipant will be asked to cycle for 10 min (<40% VO2R) and then perform the anti-saccade task |
| Moderate-Intensity Cycling | Experimental | Behavioral: Moderate-Intensity CyclingThe participant will be asked to do 10 min of cycling (40-59% VO2R) followed but the anti-saccade task |
| High-Intensity Cycling | Experimental | Behavioral: High-Intensity CyclingThe participant will be asked to do 10 min of cycling (60%-84% VO2R) followed but the anti-saccade task |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Sitting10 min bouts | Behavioural | Sitting |
| Light-Intensity Cycling10min bout | Behavioural | Low-Intensity Cycling |
| Moderate-Intensity Cycling10 min bout | Behavioural | Moderate-Intensity Cycling |
| High-Intensity Cycling10 min bout | Behavioural | High-Intensity Cycling |
Primary outcome
Reaction Time
Time frame: 30 minutes
Time in milliseconds to target
Accuracy
Time frame: 30 minutes
Directional errors
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 6 May 2024.
- Individual participant dataSharing planned: No
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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.
Harry Prapavessis, Ph.D principal investigator
Western 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 Sitting, Light-Intensity Cycling and Moderate-Intensity Cycling in people with Physical Activity, run by Western University, Canada at 1 site in Canada.
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 4 inclusion and 4 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 6 May 2024. 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 Canada. 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?
Reaction Time (time frame: 30 minutes). The study lists 2 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 6 May 2024.