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Clinical Trials/NCT00921388
NCT00921388
Completed
Not Applicable

Exercise for Smoking Cessation in Postmenopausal Women

UConn Health2 sites in 1 country301 target enrollmentMarch 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nicotine Dependence
Sponsor
UConn Health
Enrollment
301
Locations
2
Primary Endpoint
To evaluate whether adding an established moderate resistance/aerobic exercise program for postmenopausal women 45 years of age and older to a standard smoking cessation treatment program improves short and long term smoking outcomes.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This research study is being done to find out if adding a moderate exercise program or a relaxation program to a smoking cessation treatment program will improve smoking cessation and health in postmenopausal women. We hope to learn which group is more successful at quitting, has less symptoms of withdrawal from smoking and has improved health.

Detailed Description

Prevalence of smoking among women has declined more slowly in women than among men. Women who quit smoking substantially reduce the risk of premature death. A multi-modal approach to smoking cessation with combined behavioral and pharmacological interventions generally yields the highest success rates. The majority of subjects who are able to achieve abstinence return to smoking. Smoking relapse rates are 50-80% within one year with the majority of smokers relapsing within the first 3 months. Interventions are needed to both enhance smoking cessation rates and prevent relapse rates in order to substantially impact long-term quit rates.We intend to compare the effectiveness of a smoking cessation program combined with a moderate exercise program to an identical smoking cessation program combined with a relaxation-meditation control condition. In a substudy, we will also evaluate the effectiveness of the intervention in premenopausal women (N=40)

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
August 29, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
UConn Health
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Postmenopausal women at least 45 years of age
  • Smoking at least 10 cigarettes per day
  • Motivated to quit smoking
  • Ambulatory
  • Currently exercising for 90 minutes of moderate exercise or less per week
  • Motivated to exercise
  • Permission from Primary Care Provider
  • Good general health

Exclusion Criteria

  • Denied medical clearance from primary care provider
  • Unstable angina or uncompensated heart failure
  • Systolic blood pressure greater than 165 or diastolic blood pressure greater than 100
  • Heart attack or stroke within the preceding 6 months
  • Hip fracture within the preceding 6 months
  • Unstable medical or psychiatric disorder (e.g., current major depressive disorder or substance abuse or dependence)
  • Exercise-exacerbated neuromuscular disorder
  • Treatment for depression within the last year
  • Estimated creatinine clearance of less than 30cc/minute
  • Current use of a smoking cessation aid (i.e., bupropion, NRT, clonidine)

Outcomes

Primary Outcomes

To evaluate whether adding an established moderate resistance/aerobic exercise program for postmenopausal women 45 years of age and older to a standard smoking cessation treatment program improves short and long term smoking outcomes.

Time Frame: Week 12 and Week 64

Secondary Outcomes

  • To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment.(Week 12 and Week 64)

Study Sites (2)

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