SmokingSTARTNCT01705951
Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk
A study testing Resistance Training (RT) and Nicotine Replacement Therapy (NRT) in people with Smoking and Cardiovascular Disease Risk, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This project is prompted by the urgent public health need to identify novel strategies to prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data that suggests cessation of smoking results in rapid amelioration of endothelial function. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cardiovascular Disease Risk
- What is being tested?
- Resistance Training (RT) and Nicotine Replacement Therapy (NRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2013
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young Adults (18-35 yrs.)
- Male and female smokers
- Smokers (smoked at least one cigarette a day for 15 or more days in the last month and has smoked 100 cigarettes in life)
- 1-3 years experience consistently exercising/training at ≤2 days/wk of RT and ≤1 day/wk of aerobic exercise
- Capable of providing informed consent
- UCLA students/staff and Non UCLA student/staff
- Participant in good health as determined by baseline visit
Who cannot join
- Documented CAD
- Has had cardiac surgery
- Currently in weight loss or exercise program in the 6 months prior to participation.
- Use of medications that influence CV function or preclude the ability to train
- Syndromes or prescribed medications that may influence CVD, body composition, or insulin action (e.g. prednisone, Ritalin, Adderall, GH)
- Unable to exercise
Show all 11Show fewer
- Diagnosed with syndromes or diseases that may influence body composition and CV risk (e.g. Cushing syndrome).
- Known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading that would prevent someone from performing the exercise intervention. If the subject demonstrates abnormal ECG during their pre-intervention visit (or any follow-up visit) the subject's ECG will be reviewed (for approval) by a cardiologist to continue in the study.
- Pregnant
- Use of hormonal contraceptives
- Currently in a smoking cessation program including use of NRT within the month of participation
Trial locations and contacts
1 site in 1 country.
Exercise and Metabolic Disease Laboratory contact
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
About this study
This project is prompted by the urgent public health need to identify novel strategies to prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data that suggests cessation of smoking results in rapid amelioration of endothelial function. The higher prevalence of CVD and metabolic syndrome in smokers have become major health care concerns. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative. We are investigating the efficacy of resistance training to ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance in four groups: presence or absence of resistance training with or without cessation treatment + nicotine replacement.
The investigators hypothesize that resistance training will improve cardiovascular function in smokers; however, the responses will be better in those who also stop smoking. In addition, resistance training will decrease smoking, however, the effects of counseling and nicotine replacement alone or counseling and nicotine replacement in conjunction with resistance training will be better than resistance training alone.
Read the detailed description
The investigators are conducting a 12-week randomized-controlled trial of 100 young adult smokers.
At week 0, participants attend three outpatient visits at baseline. Each participant is randomized to one of four groups: Resistance Training(RT)/Nicotine Replacement Therapy (NRT), RT/No NRT, No RT/NRT, and No RT/No NRT. Those receiving RT work with a certified personal trainer 3 times per week for 12 weeks at 60 minutes each session. Those receiving NRT use the nicotine patch daily for 12 weeks and call the California Smoker's Helpline for smoking cessation counseling. Those in the control group do not receive any intervention and maintain their current lifestyle and habits.
At week 13, participants return for three post-intervention assessments.
At week 26, survey data is collected to assess changes in lifestyle habits.
- Conditions
- Smoking, Cardiovascular Disease Risk
- Being tested
- Resistance Training (RT), Nicotine Replacement Therapy (NRT)
- Keywords
- Smoking, Insulin resistance, Metabolic Syndrome, Endothelial Function, Smoking Cessation, Resistance Training, Nicotine Replacement, Exercise, Cardiovascular Disease, Arterial Stiffness, Body Composition
- Medical subject headings
- Smoking, Insulin Resistance, Metabolic Syndrome, Smoking Cessation, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training (RT)Other
Resistance Training program 3x/week at 60 minutes per session for 12 weeks.
Nicotine Replacement Therapy (NRT)Biological
Also called GlaxoSmithKline Nicoderm CQ patch
Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Resistance Training/Nicotine Replacement | Experimental | Not described Receives: Other: Resistance Training (RT); Biological: Nicotine Replacement Therapy (NRT) |
| Group 2: Resistance Training only | Experimental | Not described Receives: Other: Resistance Training (RT) |
| Group 3: Nicotine Replacement Therapy only | Experimental | Not described Receives: Biological: Nicotine Replacement Therapy (NRT) |
| Group 4: Control; no RT and no NRT | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)
Measured: 12 weeks
Secondary outcomes (3)
Smoking cessation percentage
Measured: 12 weeks
Arterial stiffness (including PWV and AIx)
Measured: 12 weeks
Number of cigarettes smoked
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of California
- Responsible party
- Principal investigator, Christian Roberts, PhD, University of California, Los Angeles
- Investigators
- Christian K Roberts, Ph.D, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705951
- Sponsor's protocol ID
- 19KT-0028
- Other IDs
- UL1TR000124
- Acronym
- START
- Status last verified
- Oct 2012
- First submitted
- 5 Oct 2012
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT01705951
- Acronym / sponsor ID
- START / 19KT-0028
- Conditions
- Smoking, Cardiovascular Disease Risk
- Keywords
- Smoking, Insulin resistance, Metabolic Syndrome, Endothelial Function, Smoking Cessation, Resistance Training, Nicotine Replacement, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of California
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Oct 2012 (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.
This project is prompted by the urgent public health need to identify novel strategies to prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data that suggests cessation of smoking results in rapid amelioration of endothelial function. The higher prevalence of CVD and metabolic syndrome in smokers have become major health care concerns. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative. We are investigating the efficacy of resistance training to ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance in four groups: presence or absence of resistance training with or without cessation treatment + nicotine replacement.
The investigators hypothesize that resistance training will improve cardiovascular function in smokers; however, the responses will be better in those who also stop smoking. In addition, resistance training will decrease smoking, however, the effects of counseling and nicotine replacement alone or counseling and nicotine replacement in conjunction with resistance training will be better than resistance training alone.
Detailed description
The investigators are conducting a 12-week randomized-controlled trial of 100 young adult smokers.
At week 0, participants attend three outpatient visits at baseline. Each participant is randomized to one of four groups: Resistance Training(RT)/Nicotine Replacement Therapy (NRT), RT/No NRT, No RT/NRT, and No RT/No NRT. Those receiving RT work with a certified personal trainer 3 times per week for 12 weeks at 60 minutes each session. Those receiving NRT use the nicotine patch daily for 12 weeks and call the California Smoker's Helpline for smoking cessation counseling. Those in the control group do not receive any intervention and maintain their current lifestyle and habits.
At week 13, participants return for three post-intervention assessments.
At week 26, survey data is collected to assess changes in lifestyle habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Resistance Training/Nicotine Replacement | Experimental | Other: Resistance Training (RT), Biological: Nicotine Replacement Therapy (NRT) |
| Group 2: Resistance Training only | Experimental | Other: Resistance Training (RT) |
| Group 3: Nicotine Replacement Therapy only | Experimental | Biological: Nicotine Replacement Therapy (NRT) |
| Group 4: Control; no RT and no NRT | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Young Adults (18-35 yrs.)
- Male and female smokers
- Smokers (smoked at least one cigarette a day for 15 or more days in the last month and has smoked 100 cigarettes in life)
- 1-3 years experience consistently exercising/training at ≤2 days/wk of RT and ≤1 day/wk of aerobic exercise
- Capable of providing informed consent
Key exclusion criteria (11 listed)
- Documented CAD
- Has had cardiac surgery
- Currently in weight loss or exercise program in the 6 months prior to participation.
- Use of medications that influence CV function or preclude the ability to train
- Syndromes or prescribed medications that may influence CVD, body composition, or insulin action (e.g. prednisone, Ritalin, Adderall, GH)
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 (RT)Resistance Training program 3x/week at 60 minutes per session for 12 weeks. | Other | Group 1: Resistance Training/Nicotine Replacement, Group 2: Resistance Training only |
| Nicotine Replacement Therapy (NRT)Also: GlaxoSmithKline Nicoderm CQ patchNicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling. | Biological | Group 1: Resistance Training/Nicotine Replacement, Group 3: Nicotine Replacement Therapy only |
Primary outcome
Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)
Time frame: 12 weeks
3 secondary outcomes
Smoking cessation percentage
Time frame: 12 weeks
Arterial stiffness (including PWV and AIx)
Time frame: 12 weeks
Number of cigarettes smoked
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Exercise and Metabolic Disease Laboratory contact
Christian K Roberts, Ph.D principal investigator
University of California, Los Angeles
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 (RT) and Nicotine Replacement Therapy (NRT) in people with Smoking and Cardiovascular Disease Risk, run by University of California, Los Angeles 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Oct 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Exercise and Metabolic Disease Laboratory (info@uclaemdr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD) (time frame: 12 weeks). 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 12 Oct 2012.