An interventional study of Resistance Training (RT) and Nicotine Replacement Therapy (NRT) in Smoking and Cardiovascular Disease Risk, sponsored by University of California, Los Angeles. Status unknown at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-12.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
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.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's planned enrollment of 100 is below the median of 117 across 250 interventional studies indexed under Smoking.
Browse Smoking studies →University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Resistance Training (RT) · Biological: Nicotine Replacement Therapy (NRT)
Other: Resistance Training (RT)
Biological: Nicotine Replacement Therapy (NRT)
Resistance Training program 3x/week at 60 minutes per session for 12 weeks.
Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling.
Also known as: GlaxoSmithKline Nicoderm CQ patch
Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)
Time frame: 12 weeks
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
Endothelial Progenitor Cells (EPC) count
EPC count is measured using a novel flow cytometry protocol.
Time frame: 12 weeks
Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)
Time frame: 12 Weeks
Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP)
Time frame: 12 Weeks
Body Composition
Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan.
Time frame: 12 Weeks
Muscle Strength
Muscle strength is evaluated by a one-Repetition Maximum (1RM) protocol and VO2 peak is assessed by a maximal incremental cardiopulmonary exercise test.
Time frame: 12 Weeks
The record gives a start of Apr 2011, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Los Angeles →