Smoking Cessation Clinical Trial
— AMIAEICOfficial title:
The Effects of Acute Aerobic Exercise on Inhibitory Control in Temporarily Abstinent Smokers
NCT number | NCT03441737 |
Other study ID # | 1795AM |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2018 |
Est. completion date | March 2019 |
Verified date | February 2024 |
Source | Western University, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 hours post participant start date | |
Secondary | Urge to Smoke | 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 | |
Secondary | 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. | 24 hours post participant start date |
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