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Group 1: Resistance Training/Nicotine Replacement for Cardiovascular Risk (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
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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
  • Cardiovascular Risk
  • Smoking

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Body Composition
Endothelial Progenitor Cells (EPC) count
Muscle Strength

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
1,561 Previous Clinical Trials
10,258,906 Total Patients Enrolled
3 Trials studying Cardiovascular Risk
2,224 Patients Enrolled for Cardiovascular Risk
University of CaliforniaOTHER
44 Previous Clinical Trials
306,758 Total Patients Enrolled
Christian K Roberts, Ph.DPrincipal InvestigatorUniversity of California, Los Angeles
~7 spots leftby Nov 2025