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Vigorous Exercise for Depressed Smokers

Primary Purpose

Nicotine Dependence, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise
health education
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring exercise, depression, smoking

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

INclusion Criteria:

  1. depressed (CES-D) score 16 or above
  2. 18 years of age
  3. female gender
  4. sedentary
  5. current cigarette smoker

Exclusion Criteria:

  1. smoking cessation medication
  2. Not able to exercise medically

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

health education

exercise

Arm Description

health education control

vigorous supervised exercise

Outcomes

Primary Outcome Measures

smoking abstinence
Smoking cessation biochemically confirmed

Secondary Outcome Measures

depressive symptoms
depressive symptoms (PHQ-9)

Full Information

First Posted
May 21, 2013
Last Updated
January 12, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01860924
Brief Title
Vigorous Exercise for Depressed Smokers
Official Title
Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this project the investigators will develop and pilot test a supervised, vigorous intensity exercise intervention for depressed female smokers. If the pilot intervention is successful the investigators will have a blueprint for a large randomized controlled trial. The long term objective is to develop interventions for depressed women that will ultimately reduce their risk of tobacco-caused disease and mortality.
Detailed Description
This project will be the first to evaluate supervised vigorous exercise for depressed smokers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Depression
Keywords
exercise, depression, smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
health education
Arm Type
Active Comparator
Arm Description
health education control
Arm Title
exercise
Arm Type
Experimental
Arm Description
vigorous supervised exercise
Intervention Type
Behavioral
Intervention Name(s)
exercise
Other Intervention Name(s)
physical activity
Intervention Description
vigorous intensity exercise
Intervention Type
Behavioral
Intervention Name(s)
health education
Other Intervention Name(s)
health
Intervention Description
education
Primary Outcome Measure Information:
Title
smoking abstinence
Description
Smoking cessation biochemically confirmed
Time Frame
6 months
Secondary Outcome Measure Information:
Title
depressive symptoms
Description
depressive symptoms (PHQ-9)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INclusion Criteria: depressed (CES-D) score 16 or above 18 years of age female gender sedentary current cigarette smoker Exclusion Criteria: smoking cessation medication Not able to exercise medically
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christi Patten, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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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Vigorous Exercise for Depressed Smokers

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