Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 8, 2007 | ||||
| Last Updated Date | July 15, 2008 | ||||
| Start Date ICMJE | February 2007 | ||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
7-day point prevalence smoking abstinence verified by saliva cotinine taken post-intervention (8 weeks after baseline) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00420160 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
7-day point prevalence smoking abstinence verified by saliva cotinine taken one month post-intervention (12 weeks after baseline) | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women? | ||||
| Official Title ICMJE | Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women? | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Acebutolol Atenolol Carvedilol Metoprolol Nadolol Pindolol Propranolol Timolol Medical problems:
Psychiatric Problems
REQUIRES MD CONSENT FOR THE SPECIFIC CONDITION
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00420160 | ||||
| Other Study ID Numbers ICMJE | 1 R03 CA119747 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | David M. Williams, Principal Investigator, The Miriam Hospital | ||||
| Study Sponsor ICMJE | The Miriam Hospital | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | The Miriam Hospital | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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