Cigarette SmokingNCT01951456
Resistance Training as an Aid to Smoking Cessation Treatment
A study testing Resistance training and Health and Wellness in people with Cigarette Smoking, run by Teachers College, Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether resistance training can aid smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Resistance training and Health and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 31 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older, smoke five or more cigarettes a day for at least the past 12 months
Who cannot join
- Participating in any type of exercise for >60 minutes/week over the past 3 months, current smokeless tobacco use, participation in an ongoing effort to quit smoking, current or planned pregnancy, any serious medical condition that would make exercise unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site
Teachers College, Columbia University
New York, New York, 10027
About this study
The purpose of this study is to determine whether resistance training can aid smoking cessation.
- Conditions
- Cigarette Smoking
- Being tested
- Resistance training, Health and Wellness
- Keywords
- Smoking cessation, resistance training
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Health and WellnessBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Participants will attend two, 45-60-minute progressive, moderate intensity resistance training sessions per week for 12 weeks. The program will maintain a format of a 5-minute warm-up, 35-50 minutes of resistance training and a 5-minute cool-down with flexibility and abdominal exercises. Receives: Behavioral: Resistance training |
| Health and Wellness | Active comparator | Participants in this group will be required to attend the exact same number of sessions as those in the Resistance Training group. Each session will last approximately 45-60 minutes. Sessions will include a practical component/demonstration, an informational video, and a handout on a pertinent healthy lifestyle topic for adults. Receives: Behavioral: Health and Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).
Measured: Change from baseline to 3 months
Secondary outcomes (15)
Cortisol
Measured: 3, 6, 12 months
Mood
Measured: 3, 6, 12 months
Cigarette cravings
Measured: 3, 6, 12 months
Abstinence self-efficacy
Measured: 3, 6, 12 months
Sleep
Measured: 3, 6, 12 months
Body composition
Measured: 3, 6, 12 months
Body weight
Measured: 3, 6, 12 months
Lung function
Measured: 3, 6, 12 months
Blood pressure
Measured: 3, 6, 12 months
Cholesterol profile
Measured: 3, 6, 12 months
Glycosylated hemoglobin
Measured: 3, 6, 12 months
Muscular strength
Measured: 3, 6, 12 months
Aerobic fitness
Six-minute walk test
Measured: 3, 6, 12 months
Smoking cessation
Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).
Measured: Change from baseline to 6 months
Smoking cessation
Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startNov 2013
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette 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
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951456
- Sponsor's protocol ID
- 1R01HL117345-01A1
- Status last verified
- Apr 2018
- First submitted
- 10 Sep 2013
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training as an Aid to Smoking Cessation Treatment
- ClinicalTrials.gov ID
- NCT01951456
- Acronym / sponsor ID
- 1R01HL117345-01A1
- Conditions
- Cigarette Smoking
- Keywords
- Smoking cessation, resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Nov 2013
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 26 Sep 2013 (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 determine whether resistance training can aid smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Behavioral: Resistance trainingParticipants will attend two, 45-60-minute progressive, moderate intensity resistance training sessions per week for 12 weeks. The program will maintain a format of a 5-minute warm-up, 35-50 minutes of resistance training and a 5-minute cool-down with flexibility and abdominal exercises. |
| Health and Wellness | Active comparator | Behavioral: Health and WellnessParticipants in this group will be required to attend the exact same number of sessions as those in the Resistance Training group. Each session will last approximately 45-60 minutes. Sessions will include a practical component/demonstration, an informational video, and a handout on a pertinent healthy lifestyle topic for adults. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 or older, smoke five or more cigarettes a day for at least the past 12 months
Key exclusion criteria (1 listed)
- Participating in any type of exercise for >60 minutes/week over the past 3 months, current smokeless tobacco use, participation in an ongoing effort to quit smoking, current or planned pregnancy, any serious medical condition that would make exercise unsafe
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 |
|---|---|---|
| Resistance training | Behavioural | Resistance training |
| Health and Wellness | Behavioural | Health and Wellness |
Primary outcome
Smoking cessation
Time frame: Change from baseline to 3 months
Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).
15 secondary outcomes
Cortisol
Time frame: 3, 6, 12 months
Mood
Time frame: 3, 6, 12 months
Cigarette cravings
Time frame: 3, 6, 12 months
Abstinence self-efficacy
Time frame: 3, 6, 12 months
Sleep
Time frame: 3, 6, 12 months
Body composition
Time frame: 3, 6, 12 months
Body weight
Time frame: 3, 6, 12 months
Lung function
Time frame: 3, 6, 12 months
Blood pressure
Time frame: 3, 6, 12 months
Cholesterol profile
Time frame: 3, 6, 12 months
Glycosylated hemoglobin
Time frame: 3, 6, 12 months
Muscular strength
Time frame: 3, 6, 12 months
Aerobic fitness
Time frame: 3, 6, 12 months
Smoking cessation
Time frame: Change from baseline to 6 months
Smoking cessation
Time frame: Change from baseline to 12 months
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 20 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Health and Wellness in people with Cigarette Smoking, run by Teachers College, Columbia University 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 1 inclusion and 1 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 20 Mar 2020. 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: Change from baseline to 3 months). 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 20 Mar 2020.