Effect of an Acute Bout of Exercise on Smoking Satisfaction

This study is currently recruiting participants.
Verified June 2012 by University of Western Ontario, Canada
Sponsor:
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01417975
First received: August 15, 2011
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

Female and male smokers will complete questionnaires and smoking behavior will be examined. After abstaining from smoking for approximately 18 hours, they will be randomized to a moderate intensity exercise groups or passive sitting group. Smoking satisfaction and smoking behavior will be assessed following treatment.

The hypotheses detailed below are specific to the randomization of participants into the following 2 groups:

  1. Moderate exercise (Experimental condition; MEG)
  2. Passive sitting (Attention control condition; PSG)

Hypothesis 1: A bout of moderate intensity exercise will be associated with decreased smoking satisfaction after a temporary period of abstinence compared to a control condition.

Hypothesis 2: Smoking topographic measures will mediate the relationship between a bout of moderate intensity exercise and smoking satisfaction.


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 Satisfaction?

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Smoking satisfaction [ Time Frame: One week ] [ Designated as safety issue: No ]
    Smoking satisfaction will be assessed using the 12-item modified version of the Cigarette Evaluation Questionnaire (mCEQ; Cappelleri, Bushmakin, Baker, Merikle, Olufade & Gilbert, 2007).


Secondary 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 taken 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.


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate Exercise Group
The moderate exercise condition will involve participants waking briskly (equivalent to moderate intensity) on a treadmill for 10 minutes. Moderate intensity exercise is defined as 40-68% of heart rate reserve (HRR). Heart rate (HR) will be monitored 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 in a chair for 10 minutes. Heart rate (HR) will be monitored in participants of the passive sitting group to help maintain group equivalency (with the moderate exercise condition) with regards to distraction effects and researcher contact.
Behavioral: Passive Sitting Group
Participants will be required to sit passively on a chair for 10 minutes.
Other Name: Sedentary

Detailed Description:

Lung cancer is the leading cause of cancer death in Canadians (Canadian Cancer Society (CCS), 2010). Cigarette smoking is responsible for 85% of these cases (CCS, 2007). Exercise has been shown to be an effective adjunct to pharmacological cessation strategies (Ussher, Taylor, & Faulkner, 2008). A recent systematic review concluded that a single bout of low to moderate intensity exercise can help regulate cravings, withdrawal symptoms and negative affect associated with quitting (Taylor, Ussher, & Faulkner, 2007).

Smoking satisfaction is an immediately reinforcing effect of nicotine. Smoking satisfaction may outweigh the temporally distant adverse health risks of smoking (Cappelleri, Bushmakin, Baker, Merikle, Olufade, & Gilbert, 2007). Varenicline, an alpha 4-beta-2 nAChR partial agonist, mimics the effect of nicotine by reducing cravings and withdrawal symptoms (Coe et al., 2005). A 12-week treatment period of varenicline has been shown to reduce smoking satisfaction (Jorenby et al., 2006). However, the effect of acute exercise on smoking satisfaction is not yet known.

Smoking topography is a key facet of smoking behaviour. Smoking behaviour can be subjectively or objectively measured by quantifying puff volume, maximum puff velocity, inter-puff interval, puff duration, number of puffs per cigarette and 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).

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 64 years of age
  • Smoke 10 or more cigarettes per day
  • Not have any medical condition that is contraindicative for exercise
  • Not be pregnant or intending on becoming pregnant over the course of the study
  • Be able to read and write in English
  • Have a telephone or e-mail account so they can be contacted
  • Successful completion of the Physical Activity Readiness Questionnaire (PAR-Q)
  • Have a 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 quite 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: NCT01417975

Contacts
Contact: Harry Prapavessis, Ph.D. 519-661-2111 ext 80173 hprapave@uwo.ca
Contact: Terri Schneider, B.A. 519-661-3211 ext 3 tschneid@uwo.ca

Locations
Canada, Ontario
The Exercise and Health Psychology Laboratory - The University of Western Ontario Recruiting
London, Ontario, Canada
Contact: Harry Prapavessis, Ph.D.    519-661-2111 ext 80173    hprapave@uwo.ca   
Contact: Terri Schneider, B.A.    519-661-3211 ext 3    tschneid@uwo.ca   
Principal Investigator: Harry Prapavessis, Ph.D.         
Sub-Investigator: Terri Schneider, B.A.         
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Harry Prapavessis, Ph.D University of Western Ontario, Canada