NCT00921388

Exercise or Relaxation for Smoking Cessation

Exercise for Smoking Cessation in Postmenopausal Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

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)

Conditions

• Nicotine Dependence
• Smoking Cessation

Interventions

Type	Name	Description
OTHER	Varenicline and smoking cessation counseling	All subjects receive smoking cessation counseling and varenicline 0.5mg daily for three days then twice a day for the next four days; then 1 mg twice a day for 11 weeks. Counseling is integrated within the exercise or relaxation treatment program.
BEHAVIORAL	Exercise or relaxation treatment	One hour exercise sessions twice a week for 8 weeks, then once a week for 8 weeks, then once every other week for 4 weeks. Subjects in the control group receive a relaxation program that controls for contact time.

Timeline

• Start date: 2009-03-01
• Primary completion: 2017-08-29
• Completion: 2017-08-29
• First posted: 2009-06-16
• Last updated: 2017-10-31

Locations

2 sites across 1 country: United States