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Getting Physical on Cigarettes: Exercise and Smoking Cessation - Preventing Relapse

Phase 2
18 Years
65 Years
Open (Enrolling)

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Trial Information

Getting Physical on Cigarettes: Exercise and Smoking Cessation - Preventing Relapse

Adding exercise to cognitive behaviour therapy (CBT) has been shown to aid smoking cessation
and lessen some of the negative consequences of withdrawal symptoms (Marcus et al., 1999;
Ussher, 2005). Recently, Prapavessis and colleagues (2007) demonstrated that their 12-week
program, consisting of supervised vigorous intensity exercise as an adjunct to nicotine
replacement therapy (NRT), facilitates smoking cessation, improves physical fitness, and
delays weight gain in women smokers. However, a smoking relapse effect was shown
post-intervention, illustrating a trend where, as abstinence decreased, physical fitness
showed a corresponding decrease and an increase in weight (also see, Marcus et al.). These
results suggest that exercise needs to be maintained if it is to be an effective aid to
smoking cessation.

In practice, long-term supervised and structured vigorous exercise regimes are beyond the
scope of smoking cessation services. Therefore, it is important to determine whether an
exercise intervention program can be developed to maintain weight and physical fitness after
program termination, and thus prevent (or reduce) smoking relapse. Teaching smokers the
necessary self-regulatory skills needed to abstain from smoking and adhere to exercise
independently may be a promising avenue through which to ensure lasting health behaviour

The Getting Physical on Cigarettes program will begin in January 2010. The main purpose of
this project is to examine whether an inexpensive, home-based lifestyle exercise maintenance
intervention can demonstrate sustained health benefits in terms of weight gain and physical
fitness benefits following an exercise and Nicotine Replacement Therapy (NRT) aided smoking
cessation program. In addition, this trial seeks to examine previously unexplored topics of
interest in the smoking abstinence literature; specifically, we are interested in whether
the nicotine metabolite ratio (3-HC/Cotinine: Schnoll et al., 2009) is a useful biomarker
for determining cessation success in relation to exercise and Nicotine Replacement Therapy
(NRT) treatment, and whether the interactive effects of exercise and smoking cessation
improve vascular health and lung function.

Four hundred and twenty adult female smokers will follow a structured and supervised 14 week
exercise-aided smoking cessation program, with the 10 week NRT program beginning at week 4.
Participants will be randomized into one of four conditions: a) Exercise Maintenance; b)
Exercise Maintenance + Relapse Prevention Booklets; c) Relapse Prevention Booklets +
Contact; and d) Contact Control. Starting at week 8, women in the Exercise Maintenance
conditions will engage in Group-Mediated Cognitive Behavioural (GMCB) therapy related to
maintaining exercise in their home environment, while women in the Contact conditions will
partake in group mediated discussions related to other health issues. The "Forever Free"
smoking replase prevention book series (Brandon, Collins, Juliano, & Lazev, 2000) will be
distributed to participants in the Relapse Prevention Booklets conditions; however, all
groups will receive the same amount of supervised exercise sessions and NRT. Following the
termination of the 14 week intervention all participants will be contacted by a trained
facilitator, who will deliver 15 minute biweekly (for the first month), monthly (for the
next 2 months), and then bimonthly (for last 8 months) intervention strategies over the
phone to continue to counsel the women according to her particular group-mediated condition.

Primary end points (i.e., smoking abstinence) will be assessed weekly throughout the 14 week
program and through follow-ups at 3, 6, and 12 months. Secondary end points (i.e., fitness,
vascular health [e.g., endothelial function, carotid plaque volume], lung function, weight
and self-regulatory cognitions) will be assessed at baseline and at week 14 as well as at 12
months. Accelerometers (ACTICALĂ’) will be used to obtain an objective measure of physical
activity at baseline, week 15 (1 week after the 14 week intervention) and at 6 and 12

The Getting Physical on Cigarettes trial will not only contribute to a better understanding
of the role exercise plays as an aid to smoking cessation, but will also explore a means of
increasing the cost-effectiveness of long-term smoking cessation programs. The findings
resulting from this trial may have important implications for improving the quality of life
among individuals who wish to stop smoking, which would, in turn, have a significant impact
on the cost of health care to the Canadian public.

Inclusion Criteria

Participants must meet the following criteria:

- Between the ages of 18 and 65

- Smoking greater than 10 cigarettes per day, have done so for the past 2 years, and
want to quit

- Engage in 2 or less 30-minute bouts of moderate or vigorous intensity exercise over
the past 6 months

- Absence of any medical condition that is contraindicative for exercise

- not 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 that we can reach you at

Exclusion criteria include:

- Contraindication to regular exercise (e.g., disability, unstable angina)

- Contraindications to using nicotine replacement therapy (NRT)

- Currently exercise more than twice a week for 30 or more minutes each bout at a
moderate to vigorous intensity level and have done so for the past 6 months

- 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 or are planning on becoming pregnant during the next year

- No Medical Doctor approval for exercise or NicoDerm patch (Nicotine Replacement
Therapy; NRT)

Type of Study:


Study Design:

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

Outcome Measure:

Smoking Behaviour

Outcome Description:

Continuous smoking behaviour will be measured from week 4-week 14, week26, week 56 (one year following quit). Smoking behaviour will be measured via self-report, breath Carbon Monoxide less than 6 parts per million, saliva cotinine.

Outcome Time Frame:

56 weeks post participant start date

Safety Issue:


Principal Investigator

Harry Prapavessis, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Western Ontario, Canada


Canada: Ethics Review Committee

Study ID:

Prapavessis NCIC RCT



Start Date:

October 2009

Completion Date:

March 2013

Related Keywords:

  • Cancer
  • smoking cessation
  • exercise maintenance
  • preventing relapse
  • weight gain
  • group-mediated cognitive behavioural therapy
  • Smoking