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OpenTrials
Completed

NCT Number: NCT03344198

Exercise & Diet Effects on CV Risk in Firefighters

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California State University San Marcos

San Marcos, California, 92096, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult
  • Able to Exercise

Exclusion criteria

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

Treatment and study plan

Circuit Training exercise & Modified Mediterranean diet

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in vascular stiffness

    Time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)

    Stiffness will be measured by pulse wave velocity

  2. Change in cardiopulmonary fitness

    Time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)

    Fitness will be measured by treadmill test

  3. Change in body composition

    Time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)

    Body composition will be measured by bioelectrical impedance

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of New Hampshire

Other

Collaborators

  • American Heart Association
  • California State University, San Marcos

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 17, 2017
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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