The Getting Physical on Cigarettes trial: Rationale and methods

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Abstract

Smoking cessation success rates are generally dismal amongst self-quitters, with a discrepancy apparent among sexes with women having lower cessation rates than men (Osler et al., 1999, Royce et al., 1997, Wetter et al., 1999). The Getting Physical on Cigarettes project aims to be the first clinical trial to appropriately evaluate the effectiveness of home-based lifestyle exercise maintenance program in assisting women to prevent smoking relapse and maintain exercise and weight following the termination of a structured and supervised exercise and nicotine replacement therapy (NRT) smoking cessation intervention. This paper outlines the rationale and methods of the trial—a supervised exercise and NRT program lasting 14 weeks, which is followed by a home-based exercise maintenance program. Sedentary female smokers will be randomized into one of four research arms: Exercise Maintenance; Exercise Maintenance + Relapse Prevention Booklets; Relapse Prevention Booklets + Contact; Contact Control. The Exercise Maintenance groups will be counseled on maintaining exercise in their home environment, while the other groups will be counseled on health issues not involving exercise or smoking. The “Forever Free” booklet series (Brandon, Collins, Juliano, & Lazev, 2000) will be distributed to participants in the Relapse Prevention groups. The primary outcome measure is continuous smoking abstinence. Secondary outcomes are exercise behaviour, and selected physiological and psychological variables. Results will assist researchers and health professionals develop and implement similar treatment interventions that are grounded in behaviour change theory.

Section snippets

Getting Physical on Cigarettes: the rationale

Cross-sectional research has shown that smoking and exercise are not compatible behaviours. The addition of exercise to traditional smoking cessation therapy (i.e., cognitive–behaviour therapy [CBT] and nicotine replacement therapy [NRT]) has been shown to aid smoking cessation in women and ameliorate some of the negative consequence of smoking withdrawal (Taylor et al., 2007, Ussher et al., 2008). Furthermore, exercise has been shown to have a positive effect on other factors that may protect

Participants

420 females, aged between 18 and 65 years, who engage in two or less 30-min sessions of moderate or vigorous intensity exercise in the previous six months, smoke in excess of 10 cigarettes per day for the past two years, and wish to achieve smoking abstinence will participate in the Getting Physical on Cigarettes trial. Exclusion criteria will include women: (a) have contraindications to regular exercise (e.g., disability, unstable angina), (b) contraindications to using NRT, (c) are on

Summary

The Getting Physical on Cigarettes project aims to be the first clinical trial to appropriately evaluate the effectiveness of home-based lifestyle exercise maintenance program in assisting women to prevent smoking relapse and maintain exercise and weight following the termination of a structured exercise and NRT smoking cessation intervention (Faulkner et al., 2006). The improvement and/or maintenance of body composition, vascular health, lung function, physical fitness and psychological

Author note

Mary E. Jung, Lyndsay Fitzgeorge, and Harry Prapavessis, School of Kinesiology, The University of Western Ontario. Guy Faulkner, Faculty of Physical Education and Health, The University of Toronto. Ralph Maddison, Faculty of Medical and Health Sciences, The University of Auckland.

This 3-year, Getting Physical on Cigarettes, project is supported by the Canadian Cancer Society Research Institute (P.I. Dr. Harry Prapavessis; Grant # 019876).

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