Clinical trial · Interventional
Getting Physical on Cigarettes - Smoking Cessation & Relapse Prevention
Getting Physical on Cigarettes: Exercise and Smoking Cessation - Preventing Relapse
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Adult female smokers will participate in an exercise-aided smoking cessation program, and will then be randomized into one of four cessation maintenance conditions: (a) Exercise Maintenance only (b) Exercise Maintenance + Relapse Prevention Booklets(c) Relapse Prevention Booklets + Contact and (d) Contact Control. Primary follow-up outcome is smoking behaviour. Secondary outcomes include exercise behaviour, Physiological measures (body composition (Dual-emission X-ray absorptiometry; DXA), vascular health (stiffness, endothelial function, carotid plaque volume), physical fitness), and Psychological measures (self-regulatory cognitions related to exercise adherence \[exercise, scheduling, barrier, relapse, and concurrent self-regulatory self-efficacy\]). The hypotheses detailed below are specific to the randomization of participants into the following 4 groups: 1. Exercise Maintenance only 2. Exercise Maintenance + Relapse Prevention Booklets 3. Relapse Prevention Booklets + Contact 4. Contact Control Hypothesis 1: Compared to quitters in the contact control condition, quitters exposed to a home-based lifestyle exercise maintenance intervention (Exercise Maintenance only and Exercise Maintenance + Relapse Prevention Booklets) will demonstrate significantly greater exercise adherence and fitness levels, as well as significantly less weight gain and smoking relapse rates following exercise-aided smoking cessation program termination. Hypothesis 2: Compared to quitters in the contact control condition, quitters exposed to relapse information only (Relapse Prevention Booklets + Contact) will experience significantly less smoking relapse following exercise-aided smoking cessation program termination. Due to the novelty and exploratory nature of the respective prevention programs, no hypotheses are specified with respect to which prevention program (exercise maintenance or relapse prevention information) will be superior to the other, or whether the additive benefits (i.e., exercise maintenance plus relapse prevention information) will be superior to one prevention program alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contact control | Behavioral | — | UNRESOLVED |
| Exercise Behaviour Maintenance | Behavioral | — | UNRESOLVED |
| Smoking Relapse prevention booklets | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Exercise Maintenance
- description
- Randomization and Group-Mediated Cognitive Behavioural therapy (GMCB) sessions will begin on week 8 of the program. Topics of self-regulation related to exercise (Social cognitive theory of self-regulation, Albert Bandura, 1991) will be discussed: monitoring, scheduling, goal setting, coping, overcoming barriers, rewards, social support. Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators 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 enhance the GMCB principles on how to maintain exercise behavior.
- interventionNames
- Behavioral: Exercise Behaviour Maintenance
- type
- EXPERIMENTAL
- label
- Ex. Maintenance + relapse prevention
- description
- The same topics of self-regulation related to exercise maintenance(Social cognitive theory of self-regulation, Albert Bandura, 1991) will be discussed: monitoring, scheduling, goal setting, coping, overcoming barriers, rewards, social support. Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators 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 enhance the Group-Mediated Cognitive Behavioural therapy (GMCB) principles on how to maintain exercise behavior. Participants in this arm will also receive the Brandon et al. (2004) Forever Free smoking relapse prevention booklets.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (7)
- BACKGROUNDBrandon TH, Collins BN, Juliano LM, Lazev AB. Preventing relapse among former smokers: a comparison of minimal interventions through telephone and mail. J Consult Clin Psychol. 2000 Feb;68(1):103-13. doi: 10.1037//0022-006x.68.1.103. PMID 10710845
- BACKGROUNDBrandon TH, Meade CD, Herzog TA, Chirikos TN, Webb MS, Cantor AB. Efficacy and cost-effectiveness of a minimal intervention to prevent smoking relapse: dismantling the effects of amount of content versus contact. J Consult Clin Psychol. 2004 Oct;72(5):797-808. doi: 10.1037/0022-006X.72.5.797. PMID 15482038
- BACKGROUNDMarcus BH, Albrecht AE, King TK, Parisi AF, Pinto BM, Roberts M, Niaura RS, Abrams DB. The efficacy of exercise as an aid for smoking cessation in women: a randomized controlled trial. Arch Intern Med. 1999 Jun 14;159(11):1229-34. doi: 10.1001/archinte.159.11.1229. PMID 10371231
- BACKGROUNDPrapavessis H, Cameron L, Baldi JC, Robinson S, Borrie K, Harper T, Grove JR. The effects of exercise and nicotine replacement therapy on smoking rates in women. Addict Behav. 2007 Jul;32(7):1416-32. doi: 10.1016/j.addbeh.2006.10.005. Epub 2006 Nov 9. PMID 17097814
- BACKGROUNDSchnoll RA, Patterson F, Wileyto EP, Tyndale RF, Benowitz N, Lerman C. Nicotine metabolic rate predicts successful smoking cessation with transdermal nicotine: a validation study. Pharmacol Biochem Behav. 2009 Mar;92(1):6-11. doi: 10.1016/j.pbb.2008.10.016. Epub 2008 Oct 31. PMID 19000709
- DERIVEDHartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4. PMID 34611902
- DERIVEDPrapavessis H, De Jesus S, Fitzgeorge L, Rollo S. Anthropometric and body composition changes in smokers vs abstainers following an exercise-aided pharmacotherapy smoking cessation trial for women. Addict Behav. 2018 Oct;85:125-130. doi: 10.1016/j.addbeh.2018.06.003. Epub 2018 Jun 7.