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CompletedNCT00420160Updated Apr 14, 2015

Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?

A Phase 2/3 interventional study of Smoking cessation treatment plus moderate intensity exercise and Smoking cessation treatment plus health education in Lung Cancer, Heart Disease and COPD, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-14.

Sponsored by The Miriam Hospital · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Heart Disease
  • COPD

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Keywords

  • Smoking cessation
  • Exercise
  • Nicotine Patch
  • Disease Prevention
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 59 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralSmoking cessation treatment plus moderate intensity exercise
  • BehavioralSmoking cessation treatment plus health education
06

What researchers measure

Primary outcomes

  1. 7-day point prevalence smoking abstinence verified by saliva cotinine taken

    Time frame: post-intervention (8 weeks after baseline)

Secondary outcomes

  1. 7-day point prevalence smoking abstinence verified by saliva cotinine

    Time frame: taken one month post-intervention (12 weeks after baseline)

07

Study locations

1 site
  • The Miriam Hospital
    Providence, Rhode Island 02903, United States
08

References and documents

Publications

  • 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. PubMed 20565161 ↗
  • 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. PubMed 21543158 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00420160
Lead sponsor
The Miriam Hospital
Collaborators
National Cancer Institute (NCI)
Responsible party
David Williams (Research Associate, The Miriam Hospital) — Principal investigator
First posted
Jan 9, 2007
Start date
Feb 2007
Primary completion
Jun 2008
Completion
Dec 2008
Last update
Apr 14, 2015

Study contacts

David M Williams, Ph.D.
principal investigator · The Miriam Hospital and Brown Medical School
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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