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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01431365
Other study ID # SmokingTopography210
Secondary ID
Status Completed
Phase N/A
First received September 7, 2011
Last updated December 12, 2014
Start date August 2011
Est. completion date December 2014

Study information

Verified date December 2014
Source University of Western Ontario, Canada
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Moderate Exercise Group
Participants will be required to walk briskly (equivalent to moderate intensity) on a treadmill for 10 minutes.
Passive Sitting Group
Participants will be required to sit passively for 10 minutes on a chair.

Locations

Country Name City State
Canada Exercise and Health Psychology Laboratory- University of Western Ontario London Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Aveyard P, West R. Managing smoking cessation. BMJ. 2007 Jul 7;335(7609):37-41. Review. — View Citation

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.

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. — View Citation

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. Review. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2012;1:CD002295. — View Citation

Zacny JP, Stitzer ML. Effects of smoke deprivation interval on puff topography. Clin Pharmacol Ther. 1985 Jul;38(1):109-15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking topography 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. One week No
Secondary Withdrawal symptoms Changes in cravings, positive and negative affect, and mood and physical symptoms will be assessed using three questionnaires. One week No
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