- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01951456
Resistance Training as an Aid to Smoking Cessation Treatment
March 19, 2020 updated by: Teachers College, Columbia University
The purpose of this study is to determine whether resistance training can aid smoking cessation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10027
- Teachers College, Columbia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Age 18 or older, smoke five or more cigarettes a day for at least the past 12 months
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Resistance training
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.
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ACTIVE_COMPARATOR: Health and Wellness
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Change from baseline to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortisol
Time Frame: 3, 6, 12 months
|
3, 6, 12 months
|
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Mood
Time Frame: 3, 6, 12 months
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3, 6, 12 months
|
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Cigarette cravings
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Abstinence self-efficacy
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Sleep
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Body composition
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Body weight
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Lung function
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Blood pressure
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Cholesterol profile
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Glycosylated hemoglobin
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Muscular strength
Time Frame: 3, 6, 12 months
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3, 6, 12 months
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Aerobic fitness
Time Frame: 3, 6, 12 months
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Six-minute walk test
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3, 6, 12 months
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Smoking cessation
Time Frame: Change from baseline to 6 months
|
Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).
|
Change from baseline to 6 months
|
|
Smoking cessation
Time Frame: Change from baseline to 12 months
|
Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).
|
Change from baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (ACTUAL)
March 31, 2019
Study Completion (ACTUAL)
March 31, 2019
Study Registration Dates
First Submitted
September 10, 2013
First Submitted That Met QC Criteria
September 23, 2013
First Posted (ESTIMATE)
September 26, 2013
Study Record Updates
Last Update Posted (ACTUAL)
March 20, 2020
Last Update Submitted That Met QC Criteria
March 19, 2020
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R01HL117345-01A1 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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