Vigorous Exercise for Depressed Smokers

Depression Clinical Trial

Official title:

Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860924
• Other study ID #: 12-006106
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: January 12, 2016
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This project will be the first to evaluate supervised vigorous exercise for depressed smokers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Nicotine Dependence

Intervention

Behavioral:
• exercise
vigorous intensity exercise
• health education
education

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking abstinence	Smoking cessation biochemically confirmed	6 months	No
Secondary	depressive symptoms	depressive symptoms (PHQ-9)	6 months	No