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Sponsors and Collaborators: |
The Miriam Hospital National Cancer Institute (NCI) |
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Information provided by: | The Miriam Hospital |
ClinicalTrials.gov Identifier: | NCT00420160 |
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 II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women? |
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) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Acebutolol Atenolol Carvedilol Metoprolol Nadolol Pindolol Propranolol Timolol
Medical problems:
Psychiatric Problems
REQUIRES MD CONSENT FOR THE SPECIFIC CONDITION
United States, Rhode Island | |
The Miriam Hospital | |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | David M Williams, Ph.D. | The Miriam Hospital and Brown Medical School |
Responsible Party: | The Miriam Hospital ( David M. Williams, Principal Investigator ) |
Study ID Numbers: | 1 R03 CA119747 |
Study First Received: | January 8, 2007 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00420160 History of Changes |
Health Authority: | United States: Institutional Review Board |
Smoking cessation Exercise Nicotine Patch Disease Prevention |
Nicotine polacrilex Thoracic Neoplasms Smoking Heart Diseases |
Respiratory Tract Diseases Nicotine Lung Neoplasms Lung Diseases |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Heart Diseases |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Cardiovascular Diseases |