Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?

NCT ID: NCT00420160

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-12-31

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 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.

Conditions

Lung Cancer; Heart Disease; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise

3x/wk 50 minutes of moderate intensity walking on treadmills + health education videos

Group Type: EXPERIMENTAL

Smoking cessation treatment plus moderate intensity exercise

Intervention Type: BEHAVIORAL

Health Education

Contact control group attending 3x/wk 50 minutes of health education videos

Group Type: OTHER

Smoking cessation treatment plus health education

Intervention Type: BEHAVIORAL

Interventions

Smoking cessation treatment plus moderate intensity exercise

Intervention Type: BEHAVIORAL

Smoking cessation treatment plus health education

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Williams

Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Williams, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital and Brown Medical School

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20565161 (View on PubMed)

Williams 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.

Reference Type: RESULT

PMID: 21543158 (View on PubMed)

Other Identifiers

1R03CA119747

Identifier Type: NIH

Identifier Source: org_study_id

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