- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431365
Effect of an Acute Bout of Exercise on Smoking Topography
Does an Acute Bout of Exercise Affect Smoking Topography?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lung cancer is the leading cause of cancer death in Canadians (Canadian Cancer Society, in which cigarette smoking is responsible for 85% of these cases. Smoking topography, a key facet of smoking behaviour, can be subjectively or objectively measured by quantifying puff volume, maximum puff velocity, interpuff interval, puff duration, number of puffs per cigarette, and the time to smoke a single cigarette. Smoking topography can estimate exposure to carcinogenic toxins present in cigarette smoking (Djordjevic, Hoffman, & Hoffman, 1997). Evidence exists to support that exercise modifies smoking topography (Katomeri & Taylor 2006; Mikhail, 1983; Reeser, 1983; Zacny & Stitzer, 1985).
Recently, Faulkner and colleagues (2011; N = 18) were the first to implement a handheld smoking topography device (CReSS Pocket) to measure smoking behaviour in the context of an acute bout of exercise after a temporary period of abstinence. They found that brisk walking influences an individual's smoking topography. In specific, participants assigned to the exercise condition smoked less per puff and took shorter puff durations, compared to the passive sitting condition. Overall, smoking topographical studies require further investigation due to methodological flaws in order to allow for the objective collection of smoking behaviour data and improved external validity in a sufficiently powered study. Furthermore, the role of cravings, withdrawal and affect as potential mediators of topographical changes due to exercise is a novel area of research.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada
- Exercise and Health Psychology Laboratory- University of Western Ontario
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 to 64 years of age
- Smoke 10 cigarettes or more per day
- Not have any medical condition that is contraindicative for exercise
- Not be pregnant or intending on being pregnant over the course of the study
- Be able to read and write in English
- Have a telephone or an email account so that they can be contacted
- Completed the Physical Activity Readiness Questionnaire (PAR-Q)
- Have Medical Doctor's clearance if they answer "YES" to one or more questions on the Physical Activity Readiness Questionnaire (PAR-Q)
- Have not been engaged in a serious quit attempt in the last six months
- Have been smoking for more than 2 years
- Must not be suffering from an illness (e.g. cold) that would affect their typical smoking behaviour
Exclusion Criteria:
- Contraindication to exercise (e.g., disability, unstable angina)
- On medication for physical and/or mental health reasons that would make compliance with the study protocol difficult or dangerous
- Have substance dependency problems (e.g., alcohol)
- Are pregnant
- Be younger than 18 years of age
- Be 64 years or older prior to completion of the study
- Have been engaged in a serious quit attempt in the last six months
- Have been smoking for less than 2 years
- Suffering from an illness (e.g. cold) that would affect their typical smoking behaviour
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Moderate Exercise Group
The moderate exercise condition will involve participants walking briskly (equivalent to moderate intensity) on a treadmill for 10 minutes.
Moderate intensity exercise will be defined as 40-68% of the resting heart rate reserve.
Heart rate (HR) will be monitored in participants using a Polar RS100 Heart Rate monitor to serve as a guide for participants to attain the appropriate intensity.
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Participants will be required to walk briskly (equivalent to moderate intensity) on a treadmill for 10 minutes.
Other Names:
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Active Comparator: Passive Sitting Group
The passive sitting condition will involve participants sitting passively for 10 minutes on a chair.
Heart rate (HR) will be monitored in participants of the passive sitting group to help maintain group equivalency (with the moderate exercise condition) in regards to distraction effects and researcher contact.
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Participants will be required to sit passively for 10 minutes on a chair.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Smoking topography
Time Frame: One week
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Smoking topography will be assessed using the Clinical Research Support System (CReSS) Pocket, a computer-based, battery-powered, hand-held unit by Plowshare Technologies®.
The CReSS Pocket has an orifice flow meter mouthpiece, and a pressure drop related to the flow rate that is produced when a puff is taken.
From the flow rate, the CReSS derives puff count (number of puffs per cigarette), puff volume (the volume of carbon monoxide take in during each puff), puff duration (length of time for each puff), inter-puff interval (amount of time between puffs), and time to first puff.
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One week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Withdrawal symptoms
Time Frame: One week
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Changes in cravings, positive and negative affect, and mood and physical symptoms will be assessed using three questionnaires.
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One week
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Collaborators and Investigators
Investigators
- Principal Investigator: Harry Prapavessis, Ph.D., Western University, Canada
Publications and helpful links
General Publications
- Zacny JP, Stitzer ML. Effects of smoke deprivation interval on puff topography. Clin Pharmacol Ther. 1985 Jul;38(1):109-15. doi: 10.1038/clpt.1985.143.
- Taylor AH, Ussher MH, Faulkner G. The acute effects of exercise on cigarette cravings, withdrawal symptoms, affect and smoking behaviour: a systematic review. Addiction. 2007 Apr;102(4):534-43. doi: 10.1111/j.1360-0443.2006.01739.x.
- Aveyard P, West R. Managing smoking cessation. BMJ. 2007 Jul 7;335(7609):37-41. doi: 10.1136/bmj.39252.591806.47. No abstract available.
- Ussher MH, Taylor A, Faulkner G. Exercise interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD002295. doi: 10.1002/14651858.CD002295.pub3.
- Taylor A, Katomeri M. Walking reduces cue-elicited cigarette cravings and withdrawal symptoms, and delays ad libitum smoking. Nicotine Tob Res. 2007 Nov;9(11):1183-90. doi: 10.1080/14622200701648896.
- Faulkner GE, Arbour-Nicitopoulos KP, & Hsin A. Cutting down one puff at a time: The acute effects of exercise on smoking behavior. Journal of Smoking Cessation (5): 130-135, 2010.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SmokingTopography210
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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