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

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized pilot clinical trial studies the use of physical activity in promoting the discontinuation of the habit of smoking (smoking cessation) in African Americans. Participating in physical activity during an actual smoking quit attempt may work better in helping African Americans stop smoking.

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.

Is exercise intervention safe for smoking cessation?

Exercise interventions, including aerobic and resistance training, are generally safe for humans. These programs have been used in various studies for smoking cessation without significant safety concerns reported. ^{1 2 3 4 5}

How does the Exercise Intervention treatment for smoking cessation differ from other treatments?

The Exercise Intervention for smoking cessation is unique because it focuses on incorporating physical activity, such as aerobic and resistance training, to help individuals quit smoking, unlike traditional methods that often rely on behavioral therapy or medication. This approach not only aids in smoking cessation but also improves overall physical fitness and health, which can be particularly beneficial for individuals with conditions like chronic obstructive pulmonary disease (COPD). ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Exercise Intervention for Smoking Cessation?

Research suggests that adding physical exercise to smoking cessation programs may help increase the chances of quitting smoking, as seen in a study where participants who exercised had a higher, though not statistically significant, quit rate compared to those who did not. Additionally, another study found that incorporating physical activity into a smoking cessation program helped some participants quit smoking for a year. ^{1 4 11 12 13}

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 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]

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 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]

Citations

1. Sweden 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Initial evaluation of a smoking cessation program incorporating physical activity promotion to Greek adults in antismoking clinics. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Participation in a population-based physical activity programme as an aid for smoking cessation: a randomised trial. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Intermittent exercise in response to cigarette cravings in the context of an Internet-based smoking cessation program. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of physical activity counseling as an aid to smoking cessation: 12 month follow-up. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of smoking cessation on exercise performance in female smokers participating in exercise training. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The efficacy of moderate-intensity exercise as an aid for smoking cessation in women: a randomized controlled trial. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation in pulmonary rehabilitation: goal or prerequisite? [2019]

10. France pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in patients with chronic obstructive pulmonary disease]. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Exercise training during pulmonary rehabilitation in chronic obstructive pulmonary disease. [2019]

12. England pubmed.ncbi.nlm.nih.gov

The role of physical activity in the context of pulmonary rehabilitation. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Smoking Cessation Interventions for Patients With Chronic Obstructive Pulmonary Disease: A NARRATIVE REVIEW WITH IMPLICATIONS FOR PULMONARY REHABILITATION. [2023]