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Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?

Phase 2/Phase 3
18 Years
65 Years
Open (Enrolling)
Lung Cancer, Heart Disease, COPD

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Trial Information

Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Never had an adverse reaction to the nicotine patch resulting in discontinuation of

- 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

- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

7-day point prevalence smoking abstinence verified by saliva cotinine taken post-intervention (8 weeks after baseline)

Principal Investigator

David M Williams, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Miriam Hospital and Brown Medical School


United States: Institutional Review Board

Study ID:

1 R03 CA119747



Start Date:

February 2007

Completion Date:

December 2008

Related Keywords:

  • Lung Cancer
  • Heart Disease
  • COPD
  • Smoking cessation
  • Exercise
  • Nicotine Patch
  • Disease Prevention
  • Heart Diseases
  • Lung Neoplasms
  • Smoking



The Miriam Hospital Providence, Rhode Island  02903