Exercise Intervention for Smoking Cessation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Nicotine patches

Must not be taking: Nicotine replacement

Disqualifiers: Pregnancy, Lactation, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether physical activity can help African Americans quit smoking more effectively. Participants will either begin a walking program before their quit date, on their quit date, or not at all, while also receiving counseling and using nicotine patches. The goal is to determine if adding exercise (Exercise Intervention) facilitates smoking cessation. Individuals who identify as African American, currently smoke daily, and are motivated to quit within the next two weeks might be suitable candidates. Participants should be willing to exercise and use nicotine patches during the study.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance smoking cessation strategies for African Americans.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking medication for blood pressure or diabetes, you will need a physician's clearance to participate.

What prior data suggests that this exercise intervention is safe for smoking cessation?

Research shows that exercise is generally safe for people trying to quit smoking. Studies have found that regular physical activity can help manage withdrawal symptoms and reduce cravings for cigarettes. It might also assist with weight control, a common concern when stopping smoking. Most people handle exercise well, with few reporting negative effects. Moderate exercise, such as brisk walking, is usually safe and can boost mood during the quitting process. Overall, exercise serves as a helpful tool for those looking to quit smoking without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how exercise might aid smoking cessation, offering a fresh approach alongside nicotine patches and counseling. Unlike standard treatments that focus solely on medication, this trial investigates the timing of physical activity, examining whether starting exercise before or on the quit date impacts success rates. The unique aspect is its emphasis on brisk, self-paced walking, which is accessible and can enhance motivation and overall well-being. By integrating physical activity into smoking cessation, researchers hope to uncover new insights into how exercise can enhance quitting outcomes.

What evidence suggests that exercise intervention might be an effective treatment for smoking cessation?

Research has shown that regular physical activity can help reduce cigarette cravings, especially for those not yet ready to quit smoking. Some studies have found that short bursts of exercise can decrease cravings and withdrawal symptoms. However, exercising over a long period doesn't always lead to quitting smoking completely. In this trial, participants in Arm I will begin physical activity two weeks before their quit date, while those in Arm II will start on their quit date. Arm III participants will not engage in physical activity. In one program, nearly 20% of participants reported not smoking after six months, and about the same number maintained regular exercise. While exercise alone might not ensure quitting, it can help manage cravings and withdrawal symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for African American daily smokers who have smoked at least 100 cigarettes in their lifetime and are currently smoking more than five a day. They must be motivated to quit within two weeks, able to do moderate exercise, and willing to use nicotine patches provided by the study. People using other cessation aids or tobacco products, pregnant or lactating individuals, those with certain medical conditions or another household member in the study cannot join.

Inclusion Criteria

I am willing to wear nicotine patches as the study requires.

Have an expired carbon monoxide (CO) level > 8 parts per million (ppm) suggestive of current smoking

Current daily smoker (has smoked >= 100 cigarettes in lifetime per self-report, smoked >= 5 cigarettes per day for the last 6 months per self-report)

Exclusion Criteria

Regular use of tobacco products other than cigarettes in the last 30 days (including black & milds)

Pregnancy or lactation

I am willing and able to follow the study's schedule and procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Quit Phase

Participants receive telephone-based cessation counseling and nicotine patch 1-2 weeks before the assigned quit date

1-2 weeks

Treatment

Participants engage in a Walking Program and receive nicotine patch for 6 weeks

6 weeks

Follow-up

Participants are monitored for mechanisms underlying smoking cessation and participate in post-intervention focus groups

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview The trial is testing if physical activity can help African Americans quit smoking when combined with nicotine patches, counseling, and monitoring through questionnaires and lab tests. Participants will be randomly assigned to either start exercising as part of their quitting process or not.

How Is the Trial Designed?

Group I: Arm II (quit day physical activity) Experimental Treatment 5 Interventions

Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning on the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise per week for 5 weeks.

Group II: Arm I (pre-quit physical activity) Experimental Treatment 5 Interventions

Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning 2 weeks before the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise activity per week for 5 weeks.

Group III: Arm III (no physical activity) Active Control 4 Interventions

Participants quit smoking on an assigned date and receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a randomized controlled trial with 61 smokers, a 12-week exercise intervention showed higher verified smoking abstinence rates compared to a health education control, suggesting that exercise may enhance smoking cessation efforts.

Participants who engaged in higher levels of moderate-to-vigorous exercise reported lower depressive symptoms, indicating that exercise could have additional mental health benefits during smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation. Abrantes, AM., Bloom, EL., Strong, DR., et al.[2021]

In a pilot study with 38 adult smokers, combining an Internet-based smoking cessation program with intermittent exercise in response to cravings did not significantly improve cessation rates compared to the program alone, indicating that while exercise may be beneficial, it does not guarantee higher success in quitting smoking.

Participants who engaged in more self-reported exercise during the intervention showed a greater reduction in smoking, suggesting that exercise could help manage cravings, but adherence to the exercise regimen remains a challenge that needs further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent exercise in response to cigarette cravings in the context of an Internet-based smoking cessation program. Linke, SE., Rutledge, T., Myers, MG.[2023]

In a study of 299 smokers undergoing a 7-week cessation program, physical activity counseling did not significantly improve long-term smoking abstinence rates compared to health education advice, with 9.1% abstinence in the exercise group versus 12.4% in the control group at 12 months.

While the exercise group showed increased physical activity levels at six weeks, these benefits did not persist at 12 months, and there was a non-significant trend towards less weight gain in the exercise group, suggesting that more intensive physical activity interventions may be needed for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of physical activity counseling as an aid to smoking cessation: 12 month follow-up. Ussher, M., West, R., McEwen, A., et al.[2007]

In a study comparing two smoking cessation programs, adding physical exercise to a multicomponent intervention showed a trend towards increased abstinence rates, with 39.4% of participants in the exercise group remaining smoke-free compared to 20.6% in the standard group, although this difference was not statistically significant.

Participants in the exercise group gained significantly more weight if they remained abstinent compared to smokers, suggesting that while exercise may help with quitting smoking, it could also lead to weight gain in those who stop smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does physical exercise in addition to a multicomponent smoking cessation program increase abstinence rate and suppress weight gain? An intervention study. Jonsdottir, D., Jonsdottir, H.[2019]

In a smoking cessation program involving 40 Greek adults, 18 participants successfully quit smoking for one year, highlighting the program's effectiveness.

Participants also increased their physical activity levels after completing the program, suggesting that integrating physical activity can be a beneficial component of smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial evaluation of a smoking cessation program incorporating physical activity promotion to Greek adults in antismoking clinics. Hassandra, M., Kofou, G., Zourbanos, N., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6819982/

Exercise interventions for smoking cessation - PubMed Central Among smokers who are not ready to quit, participation in regular physical activity has been associated with reduced cigarette cravings (Haasova 2016). Other ...

2. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2023.1221898/full

Effect of exercise intervention on smoking cessation Acute exercise interventions effectively reduce cravings and withdrawal symptoms in smokers. However, long-term exercise interventions do not significantly ...

3. bmcresnotes.biomedcentral.com bmcresnotes.biomedcentral.com/articles/10.1186/s13104-017-2762-y

Effect of exercise type on smoking cessation: a meta-analysis ... There was no effect of aerobic exercise, resisted exercise, physical activity and combined aerobic and resisted exercise on smoking cessation.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1755296617300546

Run to Quit: An evaluation of a scalable physical activity ... Results of the 6-month follow-up indicated that 19.6% of participants self-reported not smoking and 20.8% were still running regularly (M = 3 times/week).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10442508/

Effect of exercise intervention on smoking cessation Acute exercise interventions effectively reduce cravings and withdrawal symptoms in smokers. However, long-term exercise interventions do not significantly ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10226328/

The Impacts of Supervised Exercise Intervention on ... This study examined a supervised moderate-intensity aerobic exercise programme's effectiveness in regulating the Tobacco Withdrawal Symptoms ...

7. pulmonologyadvisor.com pulmonologyadvisor.com/news/physical-activity-based-smoking-cessation-intervention-was-not-more-effective/

Physical Activity-Based Smoking Cessation Intervention ... A physical activity intervention for smoking cessation was less effective than a traditional wellness intervention.