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Firefighter Cardiorespiratory Fitness (CRF) Pilot Study

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ClinicalTrials.gov Identifier: NCT03585335
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
Hologic, Inc.
Performance Plus, LLC (DBA Health Strategies)
Information provided by (Responsible Party):
HealthPartners Institute

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 330 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 risk score (CVRS) from a conjunction of body composition measures (BMI, as BF%, LBM%, WC) and demographic variables that is well-correlated with measured VO2max, evaluate the CVRS performance in age and gender-stratified subpopulations relative to the accepted standard of gender-stratified VO2max criteria, and identify age and gender-stratified CVRS threshold and diagnostic test performance. 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.

Condition or disease
Cardiorespiratory Fitness

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Development of a Cardiorespiratory Risk Surveillance Score Via Comparison of Body Composition Methods, Cardiorespiratory Fitness, and Obesity in Firefighters
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019



Primary Outcome Measures :
  1. Multivariate prediction score of cardiorespiratory risk [ Time Frame: 2 months ]
    Develop a cardiorespiratory risk score (CVRS) 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.


Secondary Outcome Measures :
  1. Correlation of non-body mass index (BMI) body composition methods with body mass index [ Time Frame: 2 months ]
    Measure body composition data and evaluate the correlation of body mass index (BMI) with non-body mass index body composition measures, such as body fat percentage (BF%), lean body mass percentage (LBM%), or waist circumference (WC) in individuals in a firefighter population.

  2. Correlation of body composition methods with measured VO2max [ Time Frame: 2 months ]
    Measure cardiorespiratory fitness in terms VO2max and evaluate the correlation of body composition measures such as body mass index (BMI), body fat percentage (BF%), lean body mass percentage (LBM%), and/or waist circumference (WC) with VO2max, in individuals in a firefighter population.

  3. Diagnostic test evaluation of body composition methods for meeting obesity criteria [ Time Frame: 2 months ]
    Evaluate diagnostic test metrics, such as sensitivity and specificity, of population meeting obesity criteria by body mass index (BMI) and waist circumference (WC), as compared to body fat percentage (BF%) as the reference standard.

  4. Direct estimated cost comparison of measured VO2max with developed prediction score [ Time Frame: 2 months ]
    Estimate cost-effectiveness of a developed cardiorespiratory risk score in comparison to measured VO2max in a firefighter population.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
330 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.
Criteria

Inclusion Criteria:

  1. Fire fighter from selected local metropolitan fire department(s)
  2. 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

Exclusion Criteria:

  1. Declined participation in the study
  2. Unwilling or do not agree to complete all data collection components of the study
  3. 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)
  4. Those who are not currently authorized to operate at full duty with their fire department without restrictions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585335


Contacts
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Contact: Zeke J McKinney, MD, MHI, MPH 651-293-8269 Zeke.J.McKinney@HealthPartners.Com
Contact: Dani M Bredeson 952-967-6738 Dani.M.Bredeson@HealthPartners.com

Locations
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United States, Minnesota
HealthPartners Institute Recruiting
Bloomington, Minnesota, United States, 55425
Contact: Zeke McKinney, MD, MPH    651-293-8269    Zeke.J.McKinney@HealthPartners.Com   
Contact: Dani Bredeson    952-967-6738    Dani.M.Bredeson@HealthPartners.com   
Sponsors and Collaborators
HealthPartners Institute
Hologic, Inc.
Performance Plus, LLC (DBA Health Strategies)

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03585335     History of Changes
Other Study ID Numbers: IIT-17-01
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by HealthPartners Institute:
Cardiorespiratory Risk Score
BMI