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NCT03585335
Firefighter Cardiorespiratory Fitness (CRF) Pilot Study
trial in Cardiorespiratory Fitness in 131 participants. Terminated before completion.
18 March 2020
Quick facts
| Lead sponsor | HealthPartners Institute |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 131 |
| Start date | 27 September 2018 |
| Primary completion | 18 March 2020 |
| Estimated completion | 18 March 2020 |
| Sites | 1 location across United States |
Conditions studied
- Cardiorespiratory Fitness — all drugs for Cardiorespiratory Fitness →
Sponsor
HealthPartners Institute
Who can join
18 and older, any sex, with Cardiorespiratory Fitness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03585335
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03585335 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HealthPartners Institute
- Last refreshed: 14 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03585335.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing