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Exercise for Depressed Smokers

Aerobic Exercise for Smokers With Depressive Symptomatology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02086149
Enrollment
231
Registered
2014-03-13
Start date
2014-02-28
Completion date
2019-02-28
Last updated
2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation, Tobacco Smoking

Keywords

Quit smoking, Exercise, Tobacco, Smoking

Brief summary

The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for helping individuals with elevated depressive symptoms to quit smoking. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in smoking cessation. The long-term goal of this program of research is to disseminate an effective, aerobic exercise (AE) intervention for smoking cessation that can be readily adopted by smokers with elevated depressive symptoms, including those with current major depressive disorder (MDD).

Interventions

BEHAVIORALAerobic Exercise

12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals. Two month course of the nicotine patch initiated during week 5.

BEHAVIORALHealth Education

12-week health education control. Weekly sessions about 12 different topics related to the health effects of smoking, led by an expert in smoking cessation.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. are between 18 and 65 years of age 2. are current smokers (i.e., smoking at least 10 cigarettes per day) 3. have currently elevated depressive symptoms (CES-D ≥ 6) 4. are sedentary, i.e., have not participated regularly in aerobic exercise (for at least 90 minutes per week during the past three months)

Exclusion criteria

1. DSM-IV diagnosis of current mania 2. DSM-IV diagnosis of bipolar rapid cycling 3. lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms 4. DSM-IV diagnosis of current substance abuse or dependence in the past 6 months 5. DSM-IV diagnosis of anorexia or bulimia nervosa 6. current suicidality or homicidality 7. marked organic impairment 8. current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months, 9. physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance) 10. current pregnancy or intent to become pregnant during the next 12 weeks 11. contraindications for use of the nicotine patch (e.g., pregnancy, recent myocardial infarction, arrhythmia, angina, untreated hypertension, untreated diabetes, and previous adverse reaction to the patch) 12. current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin) 13. current use of any pharmacotherapy or other treatment for smoking cessation.

Design outcomes

Primary

MeasureTime frameDescription
Smoking Cessation1 yearAbstinence from smoking verified biochemically (saliva cotinine)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026