Exercise & Diet Effects on CV Risk in Firefighters

August 2, 2023 updated by: Deborah Feairheller, University of New Hampshire

Effects of Combined Diet & Exercise Intervention on Cardiovascular Risk Factors in Firefighters & Civilians

The study will explore the capacity for a lifestyle modification in firefighters to improve blood pressure, blood vessel stiffness, inflammation, and reduce oxidative stress. The study will be a pre- post-testing controlled trial with three groups. The intervention will be a weekly circuit workout program and a Mediterranean (high fruit/vegetable) diet. The groups will be firefighters with >10yrs experience, firefighters with <10yrs experience, and control Non-firefighters.

Study Overview

Detailed Description

Recent statistics from the American Heart Association (AHA) have reported that >92% of adults in the U.S. meet at least 1 metric for cardiovascular disease risk factors. In firefighters, this increased risk is especially concerning. The National Fire Protection Agency (NFPA) estimates there are around 1.3 million firefighters in the United States, 70% of which are volunteer. The prevalence of impaired cardiovascular health is higher in firefighters than in the general population and the leading line-of-duty death (LODD) cause is cardiac related. It is known that exercise and diet mitigate cardiovascular disease risk. Meeting the physical activity guidelines remains a target of ideal cardiovascular health and a major public health concern. However, the NFPA does not require volunteer fire companies to have a fitness program for their crew, and sadly less than a third of the stations actually do. And importantly, cardiovascular-related LODD remains a major issue in the firefighter population. The results could guide clinical treatment for firefighters and may therefore reduce cardiac-related LODD.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Marcos, California, United States, 92096
        • California State University San Marcos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult
  • Able to Exercise

Exclusion Criteria:

  • More than one anti-hypertensive medication
  • More than one cholesterol medication
  • Diabetic
  • Prior Cardiac incident

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Firefighter (Veteran) Group
Firefighters with >10yrs experience. Circuit Training exercise & Modified Mediterranean diet
Participants will receive circuit training program and a modified Mediterranean diet program. Educational sessions, serving size training, and portion containers will be provided. Participants will also receive individualized support throughout the 6 week intervention.
Experimental: Firefighter (Novice) Group
Firefighters with <10yrs experience. Circuit Training exercise & Modified Mediterranean diet
Participants will receive circuit training program and a modified Mediterranean diet program. Educational sessions, serving size training, and portion containers will be provided. Participants will also receive individualized support throughout the 6 week intervention.
Experimental: Control Non-Firefighter Group
Non-Firefighter adults. Circuit Training exercise & Modified Mediterranean diet
Participants will receive circuit training program and a modified Mediterranean diet program. Educational sessions, serving size training, and portion containers will be provided. Participants will also receive individualized support throughout the 6 week intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure
Time Frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Blood pressure surge response to alarm will be measured by ambulatory blood pressure monitor
Pre-Intervention (Week 0), Post-Intervention (Week 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vascular stiffness
Time Frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Stiffness will be measured by pulse wave velocity
Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in cardiopulmonary fitness
Time Frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Fitness will be measured by treadmill test
Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in body composition
Time Frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Body composition will be measured by bioelectrical impedance
Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in inflammation
Time Frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Inflammation will be measured by assay of circulating bio-markers through blood draw.
Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in oxidative stress
Time Frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Oxidative stress will be measured by assay of circulating antioxidant bio-markers through blood draw.
Pre-Intervention (Week 0), Post-Intervention (Week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Deborah L Feairheller, PhD, California State University, San Marcos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2018

Primary Completion (Actual)

May 9, 2023

Study Completion (Actual)

May 9, 2023

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 005-8242-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data will be entered

IPD Sharing Time Frame

2023

IPD Sharing Access Criteria

must get approval from PI

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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