Smoking CessationAMIAEICNCT03441737
Aerobic Exercise and Inhibitory Control
A study testing Exercise and Non-Exercise in people with Smoking Cessation and Inhibition (Psychology), run by Western University, Canada.
Trial summary
Although more than half of Canadian smokers in 2015 attempted to quit, with one-third attempting more than once, successful smoking cessation (quitting) remains a challenge. Relapse (return to smoking) has been attributed to failures in inhibitory control. Inhibitory control is the ability to suppress actions. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Inhibition (Psychology)
- What is being tested?
- Exercise and Non-Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Mar 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
- 18-64 years of age
- Smoke at least 10 cigarettes per day (or more) for at least 6 months
- Able to perform a twenty-minute exercise task at a moderate intensity (2/3 of participant's maximum heart rate) without health implications
- Can read and write in English
- Have email or phone number for contacting purposes
Who cannot join
- Do not have Chronic Obstructive Pulmonary Disease
- 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
About this study
Official title: The Effects of Acute Aerobic Exercise on Inhibitory Control in Temporarily Abstinent Smokers
Although more than half of Canadian smokers in 2015 attempted to quit, with one-third attempting more than once, successful smoking cessation (quitting) remains a challenge. Relapse (return to smoking) has been attributed to failures in inhibitory control. Inhibitory control is the ability to suppress actions. Previous studies have identified that aerobic exercise improves inhibitory control and reduces the urge to smoke. This study will examine whether an acute bout of moderate intensity aerobic exercise (i.e. brisk walk on a treadmill) will improve inhibitory control, increase time to first cigarette smoked, and reduce urges to smoke during a brief period of abstinence. Inhibitory control will be assessed using the antisaccade task, which requires the participant to shift their gaze away from a visual target presented to them. Phase I will include assessments of smoking behaviours, physical activity levels, urges to smoke, and inhibitory control. Phase II will consist of a 12-hour smoking abstinence period conducted at home, followed by reassessment of urges to smoke and inhibitory control. Participants will then be randomized to either 20 minutes of aerobic exercise or sitting. Following the intervention, reassessment of urges to smoke, inhibitory control, and time to first cigarette smoked will be conducted.
Read the detailed description
The participant will be provided a letter of information and an informed consent form. Once they have signed the informed consent form, the following procedures will take place:
Phase I:
- Initial biological confirmation of carbon monoxide reading: Participant will briefly blow air into a Smokelyzer (device which assesses how much carbon monoxide in parts per million is present in the breath of a smoker)
- Baseline questionnaires: Participant will be asked to fill out to the best of their ability the following questionnaires:
- Demographic questionnaire (Asks you identifiable information concerning, your age, email telephone number)
- Smoking history questionnaire ("What is the approximate date and time of the last cigarette you have smoked?")
- Fagerstrom Test for Nicotine Dependence ("How many cigarettes do you smoke each day?")
- Godin Leisure-Time Exercise Questionnaire ("In the last 7 days, how many times have you completed mild intensity exercise for 15 minutes or more?")
- Physical Activity Readiness Questionnaire ("Do you feel pain in your chest at rest?")
- Urge to Smoke ("I have an urge for a cigarette")
- Heart rate will be measured with a heart rate monitor. Blood pressure will be measured with an electronic blood pressure cuff.
- Cognitive computer task: Participant will be asked to complete a computer task which assesses inhibitory control (the cognitive ability to suppress responses to stimuli). The Antisaccade Task will be used to assess inhibitory control in this study.
Phase II:
- Smoking abstinence period: The participant will be instructed at the end of Phase I that they will have to complete a 12 hour smoking abstinence period (refraining from smoking cigarettes or consumption of any tobacco products) at home before coming back into the lab. The participant will be also notified that the co-investigator will be able to assess whether they completed this abstinence period through assessing the carbon monoxide reading on the Smokelyzer.
- Biological confirmation of carbon monoxide reading: Participant will briefly blow air into a Smokelyzer (device which assess how much carbon monoxide in parts per million is present in the breath of a smoker). The participant will have to blow below 10 parts per million carbon monoxide to have successfully abstained and thus participate in Phase II.
- Questionnaire: Participant will be asked to fill out to the best of their ability the following questionnaire:
- Urge to Smoke ("I have an urge for a cigarette")
- Cognitive Computer Task: Participant will complete the same Antisaccade Task as outlined in Phase I.
- Intervention Participant will be randomly assigned (through a randomly generated number sequence) to either 20 minutes of aerobic exercise or 20 minutes of sitting.
- Aerobic Exercise Intervention: The participant will complete a 20 minute walking exercise on a treadmill.
- Non Exercise: The participant will be in a seated position in the lab waiting room. They will be provided with magazines and computer access.
- Post Intervention:
- Questionnaire: Participant will be asked to fill out to the best of their ability the following questionnaire:
- Urge to Smoke ("I have an urge for a cigarette")
The participant will then be told to notify the co-investigator of when they light their next cigarette through a time-stamped email or text message. The time in minutes from when they leave the lab (time: 0) until the message is received will be calculated.
- Conditions
- Smoking Cessation, Inhibition (Psychology)
- Being tested
- Exercise, Non-Exercise
- Keywords
- Aerobic exercise, Antisaccades, Urge to Smoke, Adults
- Medical subject headings
- Smoking Cessation, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
20 minutes of aerobic exercise (walking on a treadmill) at 2/3 of participant's maximum heart rate (maximum heart rate calculated as 220-age).
Non-ExerciseBehavioural
20 minutes of sitting in the laboratory with access to magazines and the internet.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Aerobic exercise intervention Receives: Behavioral: Exercise |
| Non-Exercise | Active comparator | Non-aerobic exercise intervention Receives: Behavioral: Non-Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibitory Control
Cognitive computer task: Participant will be asked to complete a computer task which assesses inhibitory control (the cognitive ability to suppress responses to stimuli). The Antisaccade Task will be used to assess inhibitory control in this study. A saccade is a rapid eye movement towards a visual target. 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. The participant will be seated in a chair facing a computer screen in which visual stimuli (a cross) will appear. The participant will be fitted into a chin rest and a monocle will be adjusted so that images of eye movements can be assessed. A training phase will take place at the beginning of the task to familiarize the participant with the instructions. The participant will make a series of saccades and antisaccades. The reaction times and directional errors to the visual stimuli will be recorded.
Measured: 24 hours post participant start date
Secondary outcomes (2)
Urge to Smoke
Questionnaire: 1 item from the Questionnaire of Smoking Urges (QSU) will be used to assess the urge to smoke.
Measured: 24 hours post participant start date
Time to First Cigarette
The time to first cigarette post intervention will be calculated from time 0 being when the participant leaves the lab until the co-investigator receives a time-stamped message from the participant that they have light their first cigarette.
Measured: 24 hours post participant start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startApr 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: Did not receive funding to support this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- Dr.Harry Prapavessis, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441737
- Sponsor's protocol ID
- 1795AM
- Acronym
- AMIAEIC
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2018
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Aerobic Exercise on Inhibitory Control in Temporarily Abstinent Smokers
- ClinicalTrials.gov ID
- NCT03441737
- Acronym / sponsor ID
- AMIAEIC / 1795AM
- Conditions
- Smoking Cessation, Inhibition (Psychology)
- Keywords
- Aerobic exercise, Antisaccades, Urge to Smoke, Adults
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive funding to support this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 22 Feb 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.
Although more than half of Canadian smokers in 2015 attempted to quit, with one-third attempting more than once, successful smoking cessation (quitting) remains a challenge. Relapse (return to smoking) has been attributed to failures in inhibitory control. Inhibitory control is the ability to suppress actions. Previous studies have identified that aerobic exercise improves inhibitory control and reduces the urge to smoke. This study will examine whether an acute bout of moderate intensity aerobic exercise (i.e. brisk walk on a treadmill) will improve inhibitory control, increase time to first cigarette smoked, and reduce urges to smoke during a brief period of abstinence. Inhibitory control will be assessed using the antisaccade task, which requires the participant to shift their gaze away from a visual target presented to them. Phase I will include assessments of smoking behaviours, physical activity levels, urges to smoke, and inhibitory control. Phase II will consist of a 12-hour smoking abstinence period conducted at home, followed by reassessment of urges to smoke and inhibitory control. Participants will then be randomized to either 20 minutes of aerobic exercise or sitting. Following the intervention, reassessment of urges to smoke, inhibitory control, and time to first cigarette smoked will be conducted.
Detailed description
The participant will be provided a letter of information and an informed consent form. Once they have signed the informed consent form, the following procedures will take place:
Phase I:
- Initial biological confirmation of carbon monoxide reading: Participant will briefly blow air into a Smokelyzer (device which assesses how much carbon monoxide in parts per million is present in the breath of a smoker)
- Baseline questionnaires: Participant will be asked to fill out to the best of their ability the following questionnaires:
- Demographic questionnaire (Asks you identifiable information concerning, your age, email telephone number)
- Smoking history questionnaire ("What is the approximate date and time of the last cigarette you have smoked?")
- Fagerstrom Test for Nicotine Dependence ("How many cigarettes do you smoke each day?")
- Godin Leisure-Time Exercise Questionnaire ("In the last 7 days, how many times have you completed mild intensity exercise for 15 minutes or more?")
- Physical Activity Readiness Questionnaire ("Do you feel pain in your chest at rest?")
- Urge to Smoke ("I have an urge for a cigarette")
- Heart rate will be measured with a heart rate monitor. Blood pressure will be measured with an electronic blood pressure cuff.
- Cognitive computer task: Participant will be asked to complete a computer task which assesses inhibitory control (the cognitive ability to suppress responses to stimuli). The Antisaccade Task will be used to assess inhibitory control in this study.
Phase II:
- Smoking abstinence period: The participant will be instructed at the end of Phase I that they will have to complete a 12 hour smoking abstinence period (refraining from smoking cigarettes or consumption of any tobacco products) at home before coming back into the lab. The participant will be also notified that the co-investigator will be able to assess whether they completed this abstinence period through assessing the carbon monoxide reading on the Smokelyzer.
- Biological confirmation of carbon monoxide reading: Participant will briefly blow air into a Smokelyzer (device which assess how much carbon monoxide in parts per million is present in the breath of a smoker). The participant will have to blow below 10 parts per million carbon monoxide to have successfully abstained and thus participate in Phase II.
- Questionnaire: Participant will be asked to fill out to the best of their ability the following questionnaire:
- Urge to Smoke ("I have an urge for a cigarette")
- Cognitive Computer Task: Participant will complete the same Antisaccade Task as outlined in Phase I.
- Intervention Participant will be randomly assigned (through a randomly generated number sequence) to either 20 minutes of aerobic exercise or 20 minutes of sitting.
- Aerobic Exercise Intervention: The participant will complete a 20 minute walking exercise on a treadmill.
- Non Exercise: The participant will be in a seated position in the lab waiting room. They will be provided with magazines and computer access.
- Post Intervention:
- Questionnaire: Participant will be asked to fill out to the best of their ability the following questionnaire:
- Urge to Smoke ("I have an urge for a cigarette")
The participant will then be told to notify the co-investigator of when they light their next cigarette through a time-stamped email or text message. The time in minutes from when they leave the lab (time: 0) until the message is received will be calculated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseAerobic exercise intervention |
| Non-Exercise | Active comparator | Behavioral: Non-ExerciseNon-aerobic exercise intervention |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-64 years of age
- Smoke at least 10 cigarettes per day (or more) for at least 6 months
- Able to perform a twenty-minute exercise task at a moderate intensity (2/3 of participant's maximum heart rate) without health implications
- Can read and write in English
- Have email or phone number for contacting purposes
Key exclusion criteria (5 listed)
- Do not have Chronic Obstructive Pulmonary Disease
- 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 |
|---|---|---|
| Exercise20 minutes of aerobic exercise (walking on a treadmill) at 2/3 of participant's maximum heart rate (maximum heart rate calculated as 220-age). | Behavioural | Exercise |
| Non-Exercise20 minutes of sitting in the laboratory with access to magazines and the internet. | Behavioural | Non-Exercise |
Primary outcome
Inhibitory Control
Time frame: 24 hours post participant start date
Cognitive computer task: Participant will be asked to complete a computer task which assesses inhibitory control (the cognitive ability to suppress responses to stimuli). The Antisaccade Task will be used to assess inhibitory control in this study. A saccade is a rapid eye movement towards a visual target. 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. The participant will be seated in a chair facing a computer screen in which visual stimuli (a cross) will appear. The participant will be fitted into a chin rest and a monocle will be adjusted so that images of eye movements can be assessed. A training phase will take place at the beginning of the task to familiarize the participant with the instructions. The participant will make a series of saccades and antisaccades. The reaction times and directional errors to the visual stimuli will be recorded.
2 secondary outcomes
Urge to Smoke
Time frame: 24 hours post participant start date
Time to First Cigarette
Time frame: 24 hours post participant start date
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 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.
Dr.Harry Prapavessis principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Non-Exercise in people with Smoking Cessation and Inhibition (Psychology), run by Western University, 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Inhibitory Control (time frame: 24 hours post participant start date). 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 4 Mar 2024.