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NCT03585335 · ClinicalTrials.gov registry record

Firefighter Cardiorespiratory Fitness (CRF) Pilot Study

A clinical trial, sponsored by HealthPartners Institute.

Terminated
Registry status
131
Enrollment target

NCT03585335: Clinical Trial study, sponsored by HealthPartners Institute.

NCT03585335 is a clinical trial that was terminated before completion, run by HealthPartners Institute. The registered enrollment target is 131 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03585335 was terminated before completion, sponsored by HealthPartners Institute.

TERMINATED
Registry status
131 participants
Enrollment target

Study Summary

Cardiorespiratory fitness is of vital importance to firefighters and yet is rarely, if ever, tested in a systematic fashion over the course of an individual firefighter's career. Investigators know that there are incremental health benefits to increased levels of fitness and reduced morbidity and mortality associated with lower levels of fitness. The proposed study will address this gap by enrolling up to 135 firefighters from local metropolitan fire departments. The goal of this cross-sectional correlational study is to address which body composition methods best correlate with cardiorespiratory fitness (CRF) in firefighters in order to define a method to combine data into a risk score predictive of fitness. Specifically, this study will 1) measure body composition data and evaluate the correlation of BMI with non-BMI body composition measures, such as body fat percentage (BF%), lean body mass percentage (LBM%), or waist circumference (WC), 2) measure cardiorespiratory fitness in terms of VO2max and evaluate the correlation of body composition measures such as BMI, BF%, LBM%, and/or WC with VO2max,, 3) evaluate diagnostic test metrics, such as sensitivity and specificity, of population meeting obesity criteria by BMI and WC, as compared to BF% as the reference standard, 4) develop a cardiorespiratory fitnessscore (CVFS) from a conjunction of body composition measures (BMI, as BF%, LBM%, WC) and demographic variables that is well-correlated with measured VO2max, evaluate the CVFS performance in age and gender-stratified subpopulations relative to the accepted standard of gender-stratified VO2max criteria, and identify age and gender-stratified CVFS threshold and diagnostic test performance; and 5) correlate CVFS performance with cardiovascular risk measures. Results of this analysis will provide pilot data and inform future work to assess whether providing more accurate data on body composition can lead to more effective reductions in cardiorespiratory risk in this

Primary Outcome

Develop a cardiorespiratory fitness score (CVFS) from a conjunction of body composition measures (Body Mass Index \[BMI\], as body fat percentage \[BF%\], lean body mass percentage \[LBM%\], and waist circumference \[WC\]) and demographic variables that is well-correlated with measured VO2max, evaluate the cardiorespiratory risk score performance in age and gender-stratified subpopulations relative to the accepted standard of gender-stratified VO2max criteria, and identify age and gender-stratif

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2018-09-27
Est. Completion 2020-03-18
HealthPartners Institute

146 total trials

Why NCT03585335 stopped before completion

NCT03585335 is an observational study that tracks outcomes without assigning an intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT03585335 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03585335 about?

NCT03585335 is a clinical study titled "Firefighter Cardiorespiratory Fitness (CRF) Pilot Study". Cardiorespiratory fitness is of vital importance to firefighters and yet is rarely, if ever, tested in a systematic fashion over the course of an individual firefighter's career. Investigators know that there are incremental health benefits to increased levels of fitness and reduced morbidity and mo...

What is the current status of trial NCT03585335?

This trial is currently terminated. The enrollment target is 131 participants. The study started on 2018-09-27. Estimated completion is 2020-03-18.

Who is sponsoring clinical trial NCT03585335?

This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03585335, the US trial registry maintained by the National Library of Medicine. NCT03585335 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.