Viewing Study NCT01705951


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Study NCT ID: NCT01705951
Status: UNKNOWN
Last Update Posted: 2012-10-12
First Post: 2012-10-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk
Sponsor: University of California, Los Angeles
Organization:

Study Overview

Official Title: Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk
Status: UNKNOWN
Status Verified Date: 2012-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: START
Brief 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. 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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
UL1TR000124 NIH None https://reporter.nih.gov/quic… View