Trial record 15 of 7620 for:    Open Studies | "Cardiovascular Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of California, Los Angeles
Sponsor:
Collaborator:
University of California
Information provided by (Responsible Party):
Christian Roberts, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01705951
First received: October 5, 2012
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Smoking
Cardiovascular Disease Risk
Other: Resistance Training (RT)
Biological: Nicotine Replacement Therapy (NRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking cessation percentage [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Arterial stiffness (including PWV and AIx) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of cigarettes smoked [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Endothelial Progenitor Cells (EPC) count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    EPC count is measured using a novel flow cytometry protocol.

  • Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan.

  • Muscle Strength [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Muscle strength is evaluated by a one-Repetition Maximum (1RM) protocol and VO2 peak is assessed by a maximal incremental cardiopulmonary exercise test.


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: GlaxoSmithKline Nicoderm CQ patch
No Intervention: Group 4: Control; no RT and no NRT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705951

Contacts
Contact: Exercise and Metabolic Disease Laboratory info@uclaemdr.com

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
University of California
Investigators
Principal Investigator: Christian K Roberts, Ph.D University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Christian Roberts, PhD, Research Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01705951     History of Changes
Other Study ID Numbers: 19KT-0028, UL1TR000124
Study First Received: October 5, 2012
Last Updated: October 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Cardiovascular Disease
Smoking
Insulin resistance
Metabolic Syndrome
Endothelial Function
Smoking Cessation
Resistance Training
Nicotine Replacement
Exercise
Arterial Stiffness
Body Composition

Additional relevant MeSH terms:
Cardiovascular Diseases
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014