- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03441737
Aerobic Exercise and Inhibitory Control (AMIAEIC)
The Effects of Acute Aerobic Exercise on Inhibitory Control in Temporarily Abstinent Smokers
Study Overview
Status
Conditions
Intervention / Treatment
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:
f. 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:
f. 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 Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr.Harry Prapavessis
- Phone Number: 80173 519-661-2111
- Email: hprapave@uwo.ca
Study Contact Backup
- Name: Anisa Morava, BSc
- Phone Number: 519-993-2866
- Email: amorava@uwo.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
Aerobic exercise intervention
|
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).
|
Active Comparator: Non-Exercise
Non-aerobic exercise intervention
|
20 minutes of sitting in the laboratory with access to magazines and the internet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours post participant start date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urge to Smoke
Time Frame: 24 hours post participant start date
|
Questionnaire: 1 item from the Questionnaire of Smoking Urges (QSU) will be used to assess the urge to smoke.
|
24 hours post participant start date
|
Time to First Cigarette
Time Frame: 24 hours post participant start date
|
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.
|
24 hours post participant start date
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr.Harry Prapavessis, Western University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1795AM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown