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Exercise or Relaxation for Smoking Cessation

Primary Purpose

Nicotine Dependence, Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Varenicline and smoking cessation counseling
Exercise or relaxation treatment
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Smoking Cessation, Exercise, Postmenopausal women, CHANTIX, varenicline

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Connecticut Health Center
  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Exercise program

Relaxation program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment.

Full Information

First Posted
June 15, 2009
Last Updated
October 27, 2017
Sponsor
UConn Health
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00921388
Brief Title
Exercise or Relaxation for Smoking Cessation
Official Title
Exercise for Smoking Cessation in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 29, 2017 (Actual)
Study Completion Date
August 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Smoking Cessation
Keywords
Smoking Cessation, Exercise, Postmenopausal women, CHANTIX, varenicline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Exercise program
Arm Title
2
Arm Type
Other
Arm Description
Relaxation program
Intervention Type
Other
Intervention Name(s)
Varenicline and smoking cessation counseling
Other Intervention Name(s)
CHANTIX
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise or relaxation treatment
Other Intervention Name(s)
exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment.
Time Frame
Week 12 and Week 64

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl A Oncken, MD MPH
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34611902
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.
Results Reference
derived

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Exercise or Relaxation for Smoking Cessation

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