Lung CancerPhase 2/3NCT00420160
Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?
A Phase 2/3 study testing Smoking cessation treatment plus moderate intensity exercise and Smoking cessation treatment plus health education in people with Lung Cancer and Heart Disease, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Heart Disease, COPD
- What is being tested?
- Smoking cessation treatment plus moderate intensity exercise and Smoking cessation treatment plus health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy sedentary smokers (> 4 per day for at least one year)
- Ages 18 to 65 years
- Must be able to give informed consent
- Must live in the area for the next 3 months
- Willing to use the nicotine patch to attempt smoking cessation
- Must receive consent to participate from primary care physician
Who cannot join
- Cannot read or write fluently in the English language
- Pregnancy or plans to attempt pregnancy
- 60 minutes or more per week of moderate or vigorous physical activity
- Smokes cigars, pipes, or uses smokeless tobacco at least once per week
- Currently in a quit smoking program
- Currently using NRT of any kind or using any other quit smoking method or treatment
Show all 47Show fewer
- Never had an adverse reaction to the nicotine patch resulting in discontinuation of use
- Poor willingness or inability to comply with protocol requirements
- An employee of the Centers for Behavioral and Preventive Medicine
- Previous participant in Commit to Quit or Fit to Quit smoking cessation studies
- Another member of the household is or has been enrolled in this study
- Currently taking a medication that might impact heart rate response, including but not limited to:
- Acebutolol Atenolol Carvedilol Metoprolol Nadolol Pindolol Propranolol Timolol
- Medical problems:
- Cardiac disease of any kind such as angina, a history of myocardial infarction or valve disease including mitral valve prolapse. Anyone with an interventional procedure such as a stent
- Pain, discomfort (or other anginal equivalent) in the chest, neck, jaw, arms or other areas that may be due to ischemia
- Cerebrovasular disease such as stroke or history of transient ischemic attacks
- Peripheral vascular disease (such as claudication)
- Diabetes (both Type I and II)
- Chronic infectious disease (HIV, hepatitis) (hepatitis A is okay)
- Liver disease
- Cystic fibrosis (CF)
- Chronic obstructive pulmonary disease (COPD) (see asthma and bronchitis under questionable)
- Interstitial lung disease
- Emphysema
- Chronic Bronchitis
- Orthopnea (difficulty breathing except in the upright position) or paroxysmal nocturnal dyspnea (sudden shortness of breath at night typically triggered by lying down)
- Current diagnosis of Chronic Fatigue Syndrome
- Current diagnosis of Fibromyalgia
- Abnormal exercise stress test
- Hypertension (anyone currently being followed and/or treated for hypertension)
- Cancer treatment (other than skin cancer) within the past 6 months
- Musculoskeletal problems such as osteoarthritis, gout, osteoporosis or back, hip or knee pain that can interfere with physical activity (i.e., walking at a brisk pace - about 3-mph)
- Any other serious medical condition that might make exercise unsafe or unwise
- Psychiatric Problems
- Hospitalization for a psychiatric disorder in the last 6 months
- Currently suicidal or psychotic, (or suicidal/psychotic in last 6 months)
- Self-report of more than three alcoholic drinks per day on 5 or more days; 5 or more alcoholic drinks on 3 or more days
- Taking these specific medications for psychiatric problems: Mood stabilizer (Lithium, Depakote, Neurontin), Antipsychotics (Haldol, Clozaril, Risperdal)
- Must be on other current psychiatric medications for at least three months
- REQUIRES MD CONSENT FOR THE SPECIFIC CONDITION
- Lightheadedness, dizziness, vertigo, or fainting
- Last electrocardiogram (EKG) performed was abnormal
- Anemia
- Previous ETT for medical reason with normal results
- Irregular heart beats or palpitations in the past two years
- Heart murmurs in the past two years - the person will need physician's consent and an echocardiogram showing no evidence of significant heart disease
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition.
Read the detailed description
This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. A number of techniques will be used to increase compliance with the treatment program, thus more effectively isolating the effects of exercise. These include: (1) a two-week run-in period prior to randomization; (2) use of behavioral contracting prior to participant randomization; and (3) performance of all exercise on-site. Smoking cessation outcomes (continuous abstinence and point prevalence abstinence) will be verified by carbon monoxide and saliva cotinine. Physical activity will be evaluated by attendance at the supervised sessions. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition.
- Conditions
- Lung Cancer, Heart Disease, COPD
- Being tested
- Smoking cessation treatment plus moderate intensity exercise, Smoking cessation treatment plus health education
- Keywords
- Smoking cessation, Exercise, Nicotine Patch, Disease Prevention
- Medical subject headings
- Lung Neoplasms, Heart Diseases, Pulmonary Disease, Chronic Obstructive, Smoking Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation treatment plus moderate intensity exerciseBehavioural
Smoking cessation treatment plus health educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 3x/wk 50 minutes of moderate intensity walking on treadmills + health education videos Receives: Behavioral: Smoking cessation treatment plus moderate intensity exercise |
| Health Education | Other | Contact control group attending 3x/wk 50 minutes of health education videos Receives: Behavioral: Smoking cessation treatment plus health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence smoking abstinence verified by saliva cotinine taken
Measured: post-intervention (8 weeks after baseline)
Secondary outcomes (1)
7-day point prevalence smoking abstinence verified by saliva cotinine
Measured: taken one month post-intervention (12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Williams, The Miriam Hospital
- Investigators
- David M Williams, Ph.D., Principal investigator, The Miriam Hospital and Brown Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420160
- Sponsor's protocol ID
- 1R03CA119747
- Status last verified
- Apr 2015
- First submitted
- 8 Jan 2007
- Last updated
- 14 Apr 2015
- Results posted
- No
Publications
Williams DM, Whiteley JA, Dunsiger S, Jennings EG, Albrecht AE, Ussher MH, Ciccolo JT, Parisi AF, Marcus BH. Moderate intensity exercise as an adjunct to standard smoking cessation treatment for women: a pilot study. Psychol Addict Behav. 2010 Jun;24(2):349-54. doi: 10.1037/a0018332.
PubMed 20565161Williams DM, Dunsiger S, Whiteley JA, Ussher MH, Ciccolo JT, Jennings EG. Acute effects of moderate intensity aerobic exercise on affective withdrawal symptoms and cravings among women smokers. Addict Behav. 2011 Aug;36(8):894-7. doi: 10.1016/j.addbeh.2011.04.001. Epub 2011 Apr 15.
PubMed 21543158
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?
- ClinicalTrials.gov ID
- NCT00420160
- Acronym / sponsor ID
- 1R03CA119747
- Conditions
- Lung Cancer, Heart Disease, COPD
- Keywords
- Smoking cessation, Exercise, Nicotine Patch, Disease Prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition.
Detailed description
This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. A number of techniques will be used to increase compliance with the treatment program, thus more effectively isolating the effects of exercise. These include: (1) a two-week run-in period prior to randomization; (2) use of behavioral contracting prior to participant randomization; and (3) performance of all exercise on-site. Smoking cessation outcomes (continuous abstinence and point prevalence abstinence) will be verified by carbon monoxide and saliva cotinine. Physical activity will be evaluated by attendance at the supervised sessions. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Smoking cessation treatment plus moderate intensity exercise3x/wk 50 minutes of moderate intensity walking on treadmills + health education videos |
| Health Education | Other | Behavioral: Smoking cessation treatment plus health educationContact control group attending 3x/wk 50 minutes of health education videos |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy sedentary smokers (> 4 per day for at least one year)
- Ages 18 to 65 years
- Must be able to give informed consent
- Must live in the area for the next 3 months
- Willing to use the nicotine patch to attempt smoking cessation
Key exclusion criteria (47 listed)
- Cannot read or write fluently in the English language
- Pregnancy or plans to attempt pregnancy
- 60 minutes or more per week of moderate or vigorous physical activity
- Smokes cigars, pipes, or uses smokeless tobacco at least once per week
- Currently in a quit smoking program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation treatment plus moderate intensity exercise | Behavioural | Exercise |
| Smoking cessation treatment plus health education | Behavioural | Health Education |
Primary outcome
7-day point prevalence smoking abstinence verified by saliva cotinine taken
Time frame: post-intervention (8 weeks after baseline)
1 secondary outcome
7-day point prevalence smoking abstinence verified by saliva cotinine
Time frame: taken one month post-intervention (12 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Results publication: PubMed 20565161Williams DM, Whiteley JA, Dunsiger S, Jennings EG, Albrecht AE, Ussher MH, Ciccolo JT, Parisi AF, Marcus BH. Moderate intensity exercise as an adjunct to standard smoking cessation treatment for women: a pilot study. Psychol Addict Behav. 2010 Jun;24(2):349-54. doi: 10.1037/a0018332.
- Results publication: PubMed 21543158Williams DM, Dunsiger S, Whiteley JA, Ussher MH, Ciccolo JT, Jennings EG. Acute effects of moderate intensity aerobic exercise on affective withdrawal symptoms and cravings among women smokers. Addict Behav. 2011 Aug;36(8):894-7. doi: 10.1016/j.addbeh.2011.04.001. Epub 2011 Apr 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Williams, Ph.D. principal investigator
The Miriam Hospital and Brown Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Smoking cessation treatment plus moderate intensity exercise and Smoking cessation treatment plus health education in people with Lung Cancer and Heart Disease, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence smoking abstinence verified by saliva cotinine taken (time frame: post-intervention (8 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00420160, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.