NCT02086149

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

5 years

First QC Date

March 11, 2014

Last Update Submit

May 1, 2019

Conditions

Tobacco SmokingSmoking Cessation

Keywords

Quit smokingExerciseTobaccoSmoking

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation

    Abstinence from smoking verified biochemically (saliva cotinine)

    1 year

Study Arms (2)

Exercise

EXPERIMENTAL

12-week moderate-intensity behavioral exercise intervention (AE)

Behavioral: Aerobic Exercise

Health Education

ACTIVE COMPARATOR

12-week health education control

Behavioral: Health Education

Interventions

Aerobic ExerciseBEHAVIORAL

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.

Exercise
Health EducationBEHAVIORAL

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.

Health Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • DSM-IV diagnosis of current mania
  • DSM-IV diagnosis of bipolar rapid cycling
  • lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms
  • DSM-IV diagnosis of current substance abuse or dependence in the past 6 months
  • DSM-IV diagnosis of anorexia or bulimia nervosa
  • current suicidality or homicidality
  • marked organic impairment
  • current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months,
  • physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance)
  • current pregnancy or intent to become pregnant during the next 12 weeks
  • 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)
  • current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin)
  • current use of any pharmacotherapy or other treatment for smoking cessation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Tobacco SmokingSmoking CessationMotor ActivitySmoking

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorTobacco UseHealth Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ana M. Abrantes, Ph.D.

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations

US(1)