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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000124 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Resistance Training/Nicotine Replacement | Experimental |
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| Group 2: Resistance Training only | Experimental |
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| Group 3: Nicotine Replacement Therapy only | Experimental |
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| Group 4: Control; no RT and no NRT | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Training (RT) | Other | Resistance Training program 3x/week at 60 minutes per session for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation percentage | 12 weeks | |
| Arterial stiffness (including PWV and AIx) | 12 weeks | |
| Number of cigarettes smoked |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Progenitor Cells (EPC) count | EPC count is measured using a novel flow cytometry protocol. | 12 weeks |
| Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Exercise and Metabolic Disease Laboratory | Contact | info@uclaemdr.com |
| Name | Affiliation | Role |
|---|---|---|
| Christian K Roberts, Ph.D | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D007333 | Insulin Resistance |
| D024821 | Metabolic Syndrome |
| D016540 | Smoking Cessation |
| D009043 | Motor Activity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Nicotine Replacement Therapy (NRT) | Biological | Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling. |
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| 12 weeks |
| 12 Weeks |
| Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP) | 12 Weeks |
| Body Composition | Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan. | 12 Weeks |
| Muscle Strength | 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D015438 | Health Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004358 | Drug Therapy |