Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk

Not Applicable

• Conditions: Smoking; Cardiovascular Disease Risk
• Interventions: Biological: Nicotine Replacement Therapy (NRT); Other: Resistance Training (RT)

• Registration Number: NCT01705951
• Lead Sponsor: University of California, Los Angeles

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Status Verified: 2012-10
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-11
• Last Update Submitted: 2012-10-11
• Study First Posted: 2012-10-12
• Last Update Posted: 2012-10-12
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

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Exclusion Criteria

• 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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 3: Nicotine Replacement Therapy only	Nicotine Replacement Therapy (NRT)	-
Group 1: Resistance Training/Nicotine Replacement	Resistance Training (RT)	-
Group 2: Resistance Training only	Resistance Training (RT)	-
Group 1: Resistance Training/Nicotine Replacement	Nicotine Replacement Therapy (NRT)	-

Primary Outcome Measures

Name	Time	Method
Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Smoking cessation percentage	12 weeks
Arterial stiffness (including PWV and AIx)	12 weeks
Number of cigarettes smoked	12 weeks

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States