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Effect of an Acute Bout of Exercise on Smoking Topography

This study is currently recruiting participants.
Verified June 2012 by University of Western Ontario, Canada
Sponsor:
Information provided by (Responsible Party):
Harry Prapavessis, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01431365
First received: September 7, 2011
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

Smokers will complete questionnaires and smoking behaviour will be examined. After abstaining from smoking for approximately 18 hours, they will be randomized to a moderate intensity exercise group or passive sitting group. Smoking behaviour (time to first puff) will be assessed following treatment.


Condition Intervention
Cancer
 Behavioral: Moderate Exercise Group
Behavioral: Passive Sitting Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does an Acute Bout of Exercise Affect Smoking Topography?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Smoking topography [ Time Frame: One week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Withdrawal symptoms [ Time Frame: One week ] [ Designated as safety issue: No ]
    Changes in cravings, positive and negative affect, and mood and physical symptoms will be assessed using three questionnaires.


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Behavioral: Moderate Exercise Group
Participants will be required to walk briskly (equivalent to moderate intensity) on a treadmill for 10 minutes.
Other Name: Physical activity
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.
 Behavioral: Passive Sitting Group
Participants will be required to sit passively for 10 minutes on a chair.
Other Name: Sedentary

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431365

Contacts
Contact: Harry Prapavessis, Ph.D. 519-661-2111 ext 80173 hprapave@uwo.ca
Contact: Stefanie De Jesus, M.A. 519-661-3211 ext 3 sdejesus@uwo.ca

Locations
Canada, Ontario
Exercise and Health Psychology Laboratory- University of Western Ontario Recruiting
London, Ontario, Canada
Contact: Harry Prapavessis, Ph.D.     519-661-2111 ext 80173     hprapave@uwo.ca    
Contact: Stefanie De Jesus, M.A.     519-661-3211 ext 3     sdejesus@uwo.ca    
Principal Investigator: Harry Prapavessis, Ph.D.            
Sub-Investigator: Stefanie De Jesus, M.A.            
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Harry Prapavessis, Ph.D. University of Western Ontario, Canada
  More Information

Additional Information:
Exercise and Health Psychology Laboratory  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Harry Prapavessis, Dr., University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01431365     History of Changes
Other Study ID Numbers: SmokingTopography210
Study First Received: September 7, 2011
Last Updated: June 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Western Ontario, Canada:
exercise
topography
cravings
smoking behaviour

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013