Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk (START)

October 11, 2012 updated by: Christian Roberts, PhD, University of California, Los Angeles

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles

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 to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Resistance Training/Nicotine Replacement
Other: Resistance Training (RT)
Resistance Training program 3x/week at 60 minutes per session for 12 weeks.
Biological: Nicotine Replacement Therapy (NRT)
Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling.
Other Names:
  • GlaxoSmithKline Nicoderm CQ patch
Experimental: Group 2: Resistance Training only
Other: Resistance Training (RT)
Resistance Training program 3x/week at 60 minutes per session for 12 weeks.
Experimental: Group 3: Nicotine Replacement Therapy only
Biological: Nicotine Replacement Therapy (NRT)
Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling.
Other Names:
  • GlaxoSmithKline Nicoderm CQ patch
No Intervention: Group 4: Control; no RT and no NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Smoking cessation percentage
Time Frame: 12 weeks
12 weeks
Arterial stiffness (including PWV and AIx)
Time Frame: 12 weeks
12 weeks
Number of cigarettes smoked
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial Progenitor Cells (EPC) count
Time Frame: 12 weeks
EPC count is measured using a novel flow cytometry protocol.
12 weeks
Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)
Time Frame: 12 Weeks
12 Weeks
Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP)
Time Frame: 12 Weeks
12 Weeks
Body Composition
Time Frame: 12 Weeks
Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan.
12 Weeks
Muscle Strength
Time Frame: 12 Weeks
Muscle strength is evaluated by a one-Repetition Maximum (1RM) protocol and VO2 peak is assessed by a maximal incremental cardiopulmonary exercise test.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

University of California

Investigators

  • Principal Investigator: Christian K Roberts, Ph.D, University of California, Los Angeles

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

April 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

October 5, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

October 12, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19KT-0028
  • UL1TR000124 (U.S. NIH Grant/Contract)

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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