Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by The Miriam Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00420160
First received: January 8, 2007
Last updated: July 15, 2008
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Heart Disease
COPD
Behavioral: Smoking cessation treatment plus moderate intensity exercise
Behavioral: Smoking cessation treatment plus health education
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

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

Secondary Outcome Measures:
  • 7-day point prevalence smoking abstinence verified by saliva cotinine taken one month post-intervention (12 weeks after baseline)

Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420160

Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: David M Williams, Ph.D. The Miriam Hospital and Brown Medical School
  More Information

No publications provided

Responsible Party: David M. Williams, Principal Investigator, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00420160     History of Changes
Other Study ID Numbers: 1 R03 CA119747
Study First Received: January 8, 2007
Last Updated: July 15, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Smoking cessation
Exercise
Nicotine Patch
Disease Prevention

Additional relevant MeSH terms:
Heart Diseases
Lung Neoplasms
Cardiovascular Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014