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Exercise Intervention for Smoking Cessation

N/A
Waitlist Available
Led By Lorna McNeill
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Self-reports motivation to quit smoking within the next 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights
No Placebo-Only Group

Study Summary

This trial looks at whether physical activity can help African Americans quit smoking.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include skin irritation from nicotine patches and typical risks associated with moderate exercise such as muscle strain. The intensity of these side effects can vary among participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I currently smoke at least 5 cigarettes daily and have smoked over 100 in my life.
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I am motivated to quit smoking in the next 2 weeks.
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I currently smoke 5 or more cigarettes daily and have smoked at least 100 in my life.
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I can do moderate exercise, as confirmed by a questionnaire or my doctor.
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I am willing to wear nicotine patches as the study requires.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post intervention focus group analysis
Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study
Retention feasibility, defined as an overall retention rate of 80% and if each enrolled participant completes >= 66.7% of study visits (>= 6 of 9 study visits)
Secondary outcome measures
Mechanisms underlying smoking cessation (e.g., stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, PA enjoyment, and heart rate variability)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (quit day physical activity)Experimental Treatment5 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 Treatment5 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 Control4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Nicotine Patch
2011
Completed Phase 4
~10480

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,942 Previous Clinical Trials
1,775,327 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,574 Previous Clinical Trials
41,224,131 Total Patients Enrolled
2 Trials studying Smokers
1,250 Patients Enrolled for Smokers
Lorna McNeillPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
2,064 Total Patients Enrolled

Media Library

Exercise Intervention Clinical Trial Eligibility Overview. Trial Name: NCT01915810 — N/A
Exercise Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT01915810 — N/A
Smokers Research Study Groups: Arm II (quit day physical activity), Arm I (pre-quit physical activity), Arm III (no physical activity)
Smokers Clinical Trial 2023: Exercise Intervention Highlights & Side Effects. Trial Name: NCT01915810 — N/A
Smokers Patient Testimony for trial: Trial Name: NCT01915810 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other investigations looked into the effects of Exercise Intervention?

"Currently, 71 Exercise Intervention trials are ongoing operations and 5 of them have reached Phase 3. Originating from Green Bay, Wisconsin, 204 locations are running clinical tests for this particular treatment."

Answered by AI

Does this trial encompass individuals of an advanced age?

"Consistent with the trial's entry conditions, participants must be at least 21 years old and no more than 65."

Answered by AI

Is there a possibility to participate in this research study?

"This medical trial seeks to enrol 45 participants aged 21-65 who are classed as healthy subjects according to the PARQ. Furthermore, those interested must self-identify as African American, be current daily smokers (>= 100 cigarettes in life and >= 5/day for past 6 months), report a willingness to quit within 2 weeks of recruitment, have a registered address and functioning phone number(s) as well as an expired carbon monoxide level exceeding 8 ppm (or physician clearance if >140/90mm Hg). Finally, patients must agree to wear nicotine patches provided by the study team and engage with physical activity based smoking cessation interventions"

Answered by AI

Is this research protocol currently open to enrollees?

"Unfortunately, this clinical trial has closed to further enrolment. It initially made an appearance on January 29th 2014 and its last update was June 29th 2022. Luckily, there are still 847 medical studies recruiting healthy subjects (HS) and 71 trials for Exercise Intervention that are actively searching for volunteers."

Answered by AI

How many human participants are being surveyed in this scientific experiment?

"Unfortunately, no further participants are being accepted for this particular clinical trial which started on January 29th 2014 and was last updated June 29th 2022. However, 847 trials involving healthy individuals (HS) and 71 physical activity studies remain open to applicants."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I am trying to quit smoking.
PatientReceived 2+ prior treatments
~7 spots leftby Jan 2026