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Firefighter Cardiorespiratory Fitness (CRF) Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585335
Recruitment Status : Active, not recruiting
First Posted : July 13, 2018
Last Update Posted : April 30, 2020
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 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.

Condition or disease
Cardiorespiratory Fitness

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Study Type : Observational
Actual Enrollment : 131 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 : July 31, 2020
Estimated Study Completion Date : August 31, 2020



Primary Outcome Measures :
  1. Multivariate prediction score of cardiorespiratory risk [ Time Frame: 2 months ]
    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.


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.



Information from the National Library of Medicine

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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
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.
Criteria

Phase I: 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

Phase II 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 scanDXA scan, and electronic data transmission of annual blood pressure and serum cholesterol surveillance data or collection of blood pressure and serum cholesterol

Phase I and Phase II: 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


Locations
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United States, Minnesota
HealthPartners Institute
Bloomington, Minnesota, United States, 55425
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    
Other Study ID Numbers: IIT-17-01
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: November 2019

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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 Fitness Score
BMI