Status:
COMPLETED
Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Heart Disease
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
PHASE3
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00420160
Start Date
February 1 2007
End Date
December 1 2008
Last Update
April 14 2015
Active Locations (1)
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1
The Miriam Hospital
Providence, Rhode Island, United States, 02903