Smoking Cessation Program for Smoking
(STEP3 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJasper Smits, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Jasper A. Smits
Disqualifiers: Regular exercise, Smoking cessation intervention, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially/ethnically diverse samples?
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Aerobic Exercise and Counseling for smoking cessation?
Research suggests that adding physical exercise to smoking cessation programs may increase the chances of quitting smoking and help manage weight gain. Although some studies show only modest improvements, there is a trend indicating that exercise can enhance the effectiveness of smoking cessation efforts.
12345Is the Smoking Cessation Program for Smoking, involving exercise and nicotine patches, generally safe for humans?
Exercise interventions, including high-intensity and supervised programs, are generally safe with rare serious adverse events. Common minor issues like muscle soreness and circulatory problems can occur, but they are not usually serious. Nicotine patches are widely used and considered safe for most people, though they can cause mild side effects like skin irritation.
678910How does the Aerobic Exercise and Counseling treatment for smoking cessation differ from other treatments?
This treatment is unique because it combines high-intensity aerobic exercise with counseling to help people quit smoking, potentially reducing cravings and improving mood, which are not typically addressed by standard smoking cessation methods like nicotine replacement therapy.
1251112Eligibility Criteria
This trial is for adults who smoke at least 5 cigarettes daily for over a year, have high anxiety sensitivity, and want to quit smoking. They must be medically cleared to participate and not already exercising regularly or receiving other smoking cessation help.Inclusion Criteria
Medical clearance to participate
I have been smoking at least 5 cigarettes a day for over a year.
You have a high level of sensitivity to anxiety, as measured by a specific questionnaire.
+3 more
Exclusion Criteria
You exercise regularly by doing moderate-intensity activities for at least 20 minutes, on at least 3 days every week.
I am currently getting help to stop smoking.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive counseling and nicotine replacement therapy, and are randomly assigned to either high-intensity or low-intensity aerobic exercise for smoking cessation
6 weeks
Weekly visits for exercise sessions
Follow-up
Participants are monitored for smoking abstinence and health outcomes
48 weeks
Periodic follow-up visits at 6, 9, and 12 months
Participant Groups
The study tests if personalized smoking cessation programs that include aerobic exercise, counseling, and nicotine patches are effective for smokers with high stress sensitivity when implemented by the YMCA in diverse communities.
2Treatment groups
Experimental Treatment
Active Control
Group I: High-Intensity Aerobic ExerciseExperimental Treatment3 Interventions
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
Group II: Low-Intensity Aerobic ExerciseActive Control3 Interventions
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
Aerobic Exercise and Counseling is already approved in United States for the following indications:
🇺🇸 Approved in United States as High-Intensity Aerobic Exercise for:
- Smoking cessation in adults with high anxiety sensitivity
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas at AustinAustin, TX
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Who Is Running the Clinical Trial?
Jasper A. SmitsLead Sponsor
University of HoustonCollaborator
Oklahoma State UniversityCollaborator
National Cancer Institute (NCI)Collaborator
YMCACollaborator
University of OklahomaCollaborator
References
Intermittent exercise in response to cigarette cravings in the context of an Internet-based smoking cessation program. [2023]Interventions using sustained aerobic exercise programs to aid smoking cessation have resulted in modest, short-term cessation rates comparable to conventional cessation methods. No smoking cessation trial to date has prescribed intermittent bouts of exercise in response to nicotine cravings.
Does physical exercise in addition to a multicomponent smoking cessation program increase abstinence rate and suppress weight gain? An intervention study. [2019]Does physical exercise in addition to a multicomponent smoking cessation program increase abstinence rate and suppress weight gain? An intervention study Tobacco use is considered the single most preventable cause of premature morbidity and mortality. Smoking cessation programs aim at two interrelated purposes, to help people to give up smoking and to prevent relapse. A multicomponent intervention consisting of nicotine replacement therapy, health education, behaviour modification therapy and counselling is widely recommended in the health care literature. Smoking cessation studies from a nursing perspective are few. The purpose of this quasi-experimental study was to compare outcomes of two nurse-managed 1-year group smoking cessation interventions. Intervention 1 (n=34) was provided at a health care centre and consisted of nicotine replacement therapy, health education, behavioural modification and individual and group counselling. In intervention 2 (n=33), provided in a health club, physical exercise was added to the intervention provided in 1. Participants were self-referred with equal numbers in both interventions. A nonsignificant difference in lapse free abstinence time (LFAT) at 1 year was demonstrated between intervention 1 (20.6%, n=7) and intervention 2 (39.4%, n=13) (p=0.16, odds ratio=2.5). The difference in weight gain between intervention groups was also nonsignificant. Within intervention comparison between abstinent participants and smokers showed that abstinent participants had gained significantly more weight than smokers in intervention 2 (p=0.001), but in intervention 1 the difference was nonsignificant (p=0.2). The small sample size in the study detracts from the significance of the findings. However, a trend is observed showing that physical exercise increases the abstinence rate of participants. The conclusion is drawn that a multicomponent smoking cessation program that includes physical exercise might be an effective intervention, but further studies with a larger sample size are needed.
Randomized controlled trial of physical activity counseling as an aid to smoking cessation: 12 month follow-up. [2007]There is some evidence to suggest that regular supervised physical activity may be useful as an aid to smoking cessation. It is unclear whether less extensive interventions confer similar benefits. This study examined whether physical activity counseling alone increases long-term smoking abstinence and physical activity levels and reduces weight gain. 299 male and female smokers were randomized to a 7-week smoking cessation program, including nicotine replacement therapy, plus either (i) physical activity counseling ('exercise', N=154), or (ii) health education advice ('control', N=145). There was no significant difference in rates of continuous smoking abstinence between the exercise group and the controls at 12 months following the quit day (9.1% versus 12.4%). Significant increases in physical activity levels observed for the exercise group versus the controls at six weeks were not maintained at 12 months. There was a non-significant tendency for less weight gain in the exercise group versus the controls at 12 months (P=0.06). Further trials are needed to examine the effect of more extensive physical activity interventions on smoking cessation, physical activity levels and post-cessation weight gain.
Initial evaluation of a smoking cessation program incorporating physical activity promotion to Greek adults in antismoking clinics. [2015]The purpose of this study was to evaluate an initial application of a smoking cessation program that integrated the promotion of physical activity (PA) as a cessation aid to Greek adults in antismoking clinics. From an initial pool of 50, 12 men and 28 women from Central Greece completed the program, and 18 of them succeeded in quitting for 1 year after the program. Additionally, after the program, they increased their PA. Suggestions for future applications of the program are further discussed.
YMCA commit to quit: randomized trial outcomes. [2021]Vigorous-intensity exercise has been shown to aid in smoking cessation, especially among women. In a previous trial, cognitive behavioral therapy (CBT) for smoking cessation plus regular vigorous aerobic exercise enhanced cessation rates, improved exercise capacity, and reduced weight gain compared to CBT plus equal contact time.
Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients.
Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]The volume of high-quality evidence supporting exercise as beneficial to cancer survivors has grown exponentially; however, the potential harms of exercise remain understudied. Consequently, the trade-off between desirable and undesirable outcomes of engaging in exercise remains unclear to clinicians and people with cancer. Practical guidance on collecting and reporting harms in exercise oncology is lacking. We present a harms reporting protocol developed and refined through exercise oncology trials since 2015.Development of the Exercise Harms Reporting Method (ExHaRM) was informed by national and international guidelines for harms reporting in clinical trials involving therapeutic goods or medical devices, with adaptations to enhance applicability to exercise. The protocol has been adjusted via an iterative process of implementation and adjustment through use in multiple exercise oncology trials involving varied cancer diagnoses (types: breast, brain, gynaecological; stages at diagnosis I-IV; primary/recurrent), and heterogeneous exercise intervention characteristics (face to face/telehealth delivery; supervised/unsupervised exercise). It has also involved the development of terms (such as, adverse outcomes, which capture all undesirable physical, psychological, social and economic outcomes) that facilitate the harms assessment process in exercise.ExHaRM involves: step 1: Monitor occurrence of adverse outcomes through systematic and non-systematic surveillance; step 2: Assess and record adverse outcomes, including severity, causality, impact on intervention and type; step 3: Review of causality by harms panel (and revise as necessary); and step 4: Analyse and report frequencies, rates and clinically meaningful details of all-cause and exercise-related adverse outcomes.ExHaRM provides guidance to improve the quality of harms assessment and reporting immediately, while concurrently providing a framework for future refinement. Future directions include, but are not limited to, standardising exercise-specific nomenclature and methods of assessing causality.
Exercise prescription guidelines for normal and cardiac populations. [2008]The basic components of aerobic exercise prescription include recommendations for optimal frequency, intensity, duration, mode, and progression of activity. The most effective program design involves the use of each of these components and incorporates specific coexistent medical problems and objective data derived from a multistage exercise tolerance test. In addition to the prescription of aerobic exercise, the use of circuit weight training and recreational activities has become accepted as an important part of a comprehensive exercise prescription. In effecting a well-designed and safe exercise program, the clinician must also be aware of environmental considerations and the effect of cardiac medications on the response to exercise.
High-intensity exercise interventions in cancer survivors: a systematic review exploring the impact on health outcomes. [2022]There is an increasing body of evidence underpinning high-intensity exercise as an effective and time-efficient intervention for improving health in cancer survivors. The aim of this study was to, (1) evaluate the efficacy and (2) the safety of high-intensity exercise interventions in improving selected health outcomes in cancer survivors.
Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]Objectives: Exercise interventions during and after treatment for pediatric cancer are associated with beneficial physical, psychological, and social effects. However, valid data about adverse events (AEs) of such interventions have rarely been evaluated. This retrospective study evaluates AEs that occurred during supervised oncological exercise programs for pediatric cancer patients and survivors. Methods: This Germany-wide study used a self-administered online survey focusing on general program characteristics and AEs retrospectively for 2019. The questionnaire included (a) basic data on the offered exercise program, (b) AEs with consequences (Grade 2-5) that occurred in 2019 during an exercise intervention, (c) number of Grade 1 AEs, (d) safety procedures as part of the exercise programs, and (e) possibility to give feedback and describe experience with AEs in free text. Results: Out of 26 eligible exercise programs, response rate of program leaders was 92.3% (n = 24). Representatives working for Universities (n = 6), rehabilitation clinics (n = 3), acute cancer clinics (n = 12), and activity camps (n = 3) participated. In total, 35,110 exercise interventions with varying duration were recorded for 2019. Six AEs with consequences (Grade 2-3) occurred during exercise interventions after cancer treatment resulting in an incidence of 17 per 100,000 exercise interventions (0.017%). No life-threatening consequences or death were reported and no serious AE occurred during acute cancer treatment. Grade 1 AE occurred with a frequency of 983, corresponding to an incidence of 2,800 per 100,000 interventions (2.8%). Most frequent Grade 1 AE were muscle soreness, circulatory problems, and abdominal pain. The most frequent preventive safety procedures at the institutions were regular breaks, consultations with the medical treatment team, and material selection with low injury potential. Conclusions: Supervised exercise interventions for pediatric cancer patients and survivors seem to be safe and AEs with consequences comparatively rare when compared to general childhood population data. Occurrence of grade 1 AEs was common, however, causality was probably not evident between AEs and the exercise intervention. Future research should standardize assessment of AEs in clinical practice and research, and prospectively register and evaluate AEs that occur in the context of exercise interventions in pediatric cancer patients and survivors.
Acute Effects of Aerobic Exercise on Affect and Smoking Craving in the Weeks Before and After a Cessation Attempt. [2022]Aerobic exercise may improve smoking abstinence via reductions in craving and negative affect and increases in positive moods. Acute changes in craving and affect before and after structured exercise sessions have not been examined during the weeks prior to and following quit attempts nor has smoking status been examined in relation to these effects. Given that regular cigarette smoking can be perceived as affect enhancing and craving reducing, it is not known whether exercise could contribute additional affective benefit beyond these effects.
A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation. [2021]Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation.