Tobacco SmokingNCT02086149
Exercise for Depressed Smokers
A study testing Aerobic Exercise and Health Education in people with Tobacco Smoking and Smoking Cessation, run by Butler Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Smoking, Smoking Cessation
- What is being tested?
- Aerobic Exercise and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Exercise for Smokers With Depressive Symptomatology
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).
- Conditions
- Tobacco Smoking, Smoking Cessation
- Being tested
- Aerobic Exercise, Health Education
- Keywords
- Quit smoking, Exercise, Tobacco, Smoking
- Medical subject headings
- Tobacco Smoking, Smoking Cessation, Motor Activity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
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.
Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 12-week moderate-intensity behavioral exercise intervention (AE) Receives: Behavioral: Aerobic Exercise |
| Health Education | Active comparator | 12-week health education control Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Abstinence from smoking verified biochemically (saliva cotinine)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ana M. Abrantes, Ph.D., Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086149
- Sponsor's protocol ID
- 1304-001
- Other IDs
- R01CA173551
- Status last verified
- May 2019
- First submitted
- 11 Mar 2014
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise for Smokers With Depressive Symptomatology
- ClinicalTrials.gov ID
- NCT02086149
- Acronym / sponsor ID
- 1304-001
- Conditions
- Tobacco Smoking, Smoking Cessation
- Keywords
- Quit smoking, Exercise, Tobacco, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2014 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Aerobic Exercise12-week moderate-intensity behavioral exercise intervention (AE) |
| Health Education | Active comparator | Behavioral: Health Education12-week health education control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise12-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. | Behavioural | Exercise |
| Health Education12-week health education control. Weekly sessions about 12 different topics related to the health effects of smoking, led by an expert in smoking cessation. | Behavioural | Health Education |
Primary outcome
Smoking Cessation
Time frame: 1 year
Abstinence from smoking verified biochemically (saliva cotinine)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M. Abrantes, Ph.D. principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Health Education in people with Tobacco Smoking and Smoking Cessation, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.