Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk
START
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 5, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 12, 2012
October 1, 2012
2.7 years
October 5, 2012
October 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)
12 weeks
Secondary Outcomes (3)
Smoking cessation percentage
12 weeks
Arterial stiffness (including PWV and AIx)
12 weeks
Number of cigarettes smoked
12 weeks
Other Outcomes (5)
Endothelial Progenitor Cells (EPC) count
12 weeks
Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)
12 Weeks
Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP)
12 Weeks
- +2 more other outcomes
Study Arms (4)
Group 1: Resistance Training/Nicotine Replacement
EXPERIMENTALGroup 2: Resistance Training only
EXPERIMENTALGroup 3: Nicotine Replacement Therapy only
EXPERIMENTALGroup 4: Control; no RT and no NRT
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- University of Californiacollaborator
Study Sites (1)
University of California, Los Angeles
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian K Roberts, Ph.D
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate Professor
Study Record Dates
First Submitted
October 5, 2012
First Posted
October 12, 2012
Study Start
April 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
October 12, 2012
Record last verified: 2012-10