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Group 1: Resistance Training/Nicotine Replacement for Smoking (START Trial)

N/A
Waitlist Available
Led By Christian K Roberts, Ph.D
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

START 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.

Eligible Conditions
  • Smoking
  • Cardiovascular Risk

START Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)
Secondary outcome measures
Arterial Stiffness
Number of cigarettes smoked
Smoking cessation percentage
Other outcome measures
Body Composition
Endothelial Progenitor Cells (EPC) count
Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)
+2 more

START Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 3: Nicotine Replacement Therapy onlyExperimental Treatment1 Intervention
Group II: Group 2: Resistance Training onlyExperimental Treatment1 Intervention
Group III: Group 1: Resistance Training/Nicotine ReplacementExperimental Treatment2 Interventions
Group IV: Group 4: Control; no RT and no NRTActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,278,102 Total Patients Enrolled
6 Trials studying Smoking
320 Patients Enrolled for Smoking
University of CaliforniaOTHER
42 Previous Clinical Trials
417,248 Total Patients Enrolled
1 Trials studying Smoking
718 Patients Enrolled for Smoking
Christian K Roberts, Ph.DPrincipal InvestigatorUniversity of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Apr 2025