Clinical trial NCT00921388: Exercise or Relaxation for Smoking Cessation
Official title: Exercise for Smoking Cessation in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Smoking Cessation
Keywords: Smoking Cessation
Exercise
Postmenopausal women
CHANTIX
varenicline
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2009-06-16
Enrollment: 301
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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)
* Current use of psychotropic medication for a psychiatric problem
* Prescription narcotic abuse or dependence with the exception of people that have been stabilized on Methadone Maintenance or Suboxone
* Previous serious adverse event with Chantix use

Primary outcomes:
measure: 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.
timeFrame: Week 12 and Week 64
Secondary outcomes:
measure: To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment.
timeFrame: Week 12 and Week 64
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: UConn Health
name: Cheryl A Oncken, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.