Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk

Smoking Clinical Trial

— START  

Official title:

Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01705951
• Other study ID #: 19KT-0028
• Secondary ID: UL1TR000124
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2012
• Last updated: October 11, 2012
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2012
• Source: University of California, Los Angeles
• Contact: Exercise and Metabolic Disease Laboratory
• Email: info[@]uclaemdr.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease Risk
• Cardiovascular Diseases
• Smoking

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	University of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endothelial Progenitor Cells (EPC) count	EPC count is measured using a novel flow cytometry protocol.	12 weeks	No
Other	Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)		12 Weeks	No
Other	Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP)		12 Weeks	No
Other	Body Composition	Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan.	12 Weeks	No
Other	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	No
Primary	Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)		12 weeks	No
Secondary	Smoking cessation percentage		12 weeks	No
Secondary	Arterial stiffness (including PWV and AIx)		12 weeks	No
Secondary	Number of cigarettes smoked		12 weeks	No

External Links

•   UCLA Exercise and Metabolic Disease Research Lab Webpage