Firefighter Cardiorespiratory Fitness (CRF) Pilot Study

NCT03585335 | Terminated

• 1 other identifier: IIT-17-01
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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 population.

Conditions

Cardiorespiratory Fitness

Keywords

Cardiorespiratory Fitness Score; BMI

Outcome Measures

Primary Outcomes (1)

• Multivariate prediction score of cardiorespiratory risk

  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-stratified cardiorespiratory risk score threshold and diagnostic test performance.

  2 months

Secondary Outcomes (4)

• Correlation of non-body mass index (BMI) body composition methods with body mass index

  2 months

• Correlation of body composition methods with measured VO2max

  2 months

• Diagnostic test evaluation of body composition methods for meeting obesity criteria

  2 months

• Direct estimated cost comparison of measured VO2max with developed prediction score

  2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

135 firefighters from local metropolitan fire departments will be enrolled in this study. To minimize selection bias, although individual firefighters may opt out of the study, an attempt will be made to enroll all firefighters from an individual department to minimize volunteer bias.

You may qualify if:

• Fire fighter from selected local metropolitan fire department(s)
• Willing and agree to complete all data collection components of the study - Anthropometrics, participant survey, Concept 2 Rower Test 2,000 meter test, Treadmill VO2max Test, and DXA scan
• Fire fighter from selected local metropolitan fire department(s)
• Willing and agree to complete all data collection components of the study - Anthropometrics, participant survey, Concept 2 Rower Test 2,000 meter test, Treadmill VO2max Test, and DXA scanDXA scan, and electronic data transmission of annual blood pressure and serum cholesterol surveillance data or collection of blood pressure and serum cholesterol

You may not qualify if:

• Declined participation in the study
• Unwilling or do not agree to complete all data collection components of the study
• Pregnant females or females who anticipate being pregnant during the course of the study due to administration of the VO2max fitness test and DXA scan (pregnancy may not appropriately reflect an active-duty firefighter's cardiorespiratory fitness and radiation exposure will be avoided in pregnant individuals)
• Those who are not currently authorized to operate at full duty with their fire department without restrictions

Sponsors & Collaborators

• HealthPartners Institute: lead
• Hologic, Inc.: collaborator
• Performance Plus, LLC (DBA Health Strategies): collaborator

Study Sites (1)

HealthPartners Institute

Bloomington, Minnesota, 55425, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 13, 2018
• Study Start: September 27, 2018
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: April 14, 2021

Record last verified: 2020-12

Locations

US (1)