Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?

April 10, 2015 updated by: David Williams, The Miriam Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
3x/wk 50 minutes of moderate intensity walking on treadmills + health education videos
Behavioral: Smoking cessation treatment plus moderate intensity exercise
Other: Health Education
Contact control group attending 3x/wk 50 minutes of health education videos
Behavioral: Smoking cessation treatment plus health education

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David M Williams, Ph.D., The Miriam Hospital and Brown Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R03CA119747 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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