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CompletedNCT03344198Updated Aug 7, 2023

Exercise & Diet Effects on CV Risk in Firefighters

An interventional study of Circuit Training exercise & Modified Mediterranean diet in Cardiovascular Risk Factor, Blood Pressure and Exercise, sponsored by University of New Hampshire. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by University of New Hampshire · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Cardiovascular Risk Factor
  • Blood Pressure
  • Exercise
  • Diet Modification
  • Health Promotion

Keywords

  • Cardiovascular Disease
  • Mediterranean Diet
  • Exercise Training
  • Blood Pressure
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult
  • Able to Exercise

Exclusion criteria

Exclusion Criteria:

  • More than one anti-hypertensive medication
  • More than one cholesterol medication
  • Diabetic
  • Prior Cardiac incident
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Firefighter (Veteran) Group

    Firefighters with \>10yrs experience. Circuit Training exercise \& Modified Mediterranean diet

    Behavioral: Circuit Training exercise & Modified Mediterranean diet

  • Experimental
    Firefighter (Novice) Group

    Firefighters with \<10yrs experience. Circuit Training exercise \& Modified Mediterranean diet

    Behavioral: Circuit Training exercise & Modified Mediterranean diet

  • Experimental
    Control Non-Firefighter Group

    Non-Firefighter adults. Circuit Training exercise \& Modified Mediterranean diet

    Behavioral: Circuit Training exercise & Modified Mediterranean diet

Interventions

  • BehavioralCircuit 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.

05

What researchers measure

Primary outcomes

  1. Change in blood pressure

    Blood pressure surge response to alarm will be measured by ambulatory blood pressure monitor

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

Secondary outcomes

  1. Change in vascular stiffness

    Stiffness will be measured by pulse wave velocity

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

  2. Change in cardiopulmonary fitness

    Fitness will be measured by treadmill test

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

  3. Change in body composition

    Body composition will be measured by bioelectrical impedance

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

  4. Change in inflammation

    Inflammation will be measured by assay of circulating bio-markers through blood draw.

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

  5. Change in oxidative stress

    Oxidative stress will be measured by assay of circulating antioxidant bio-markers through blood draw.

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

06

Study locations

1 site
  • California State University San Marcos
    San Marcos, California 92096, United States
07

References and documents

Publications

  • Donahue S, McMorrow C, Almeida AA, Feairheller DL. Feasibility and Perception of a Diet and Exercise Intervention Delivered via Telehealth to Firefighters. Int J Telerehabil. 2022 Jun 3;14(1):e6458. doi: 10.5195/ijt.2022.6458. eCollection 2022. PubMed 35734390 ↗
  • Almeida AA, Reeve EH, Dickinson RL, Carty M, Gilpin J, Feairheller DL. Civilians Have Higher Adherence and More Improvements in Health With a Mediterranean Diet and Circuit Training Program Compared With Firefighters. J Occup Environ Med. 2022 Jun 1;64(6):488-494. doi: 10.1097/JOM.0000000000002478. Epub 2022 Jan 4. PubMed 34985026 ↗
  • Feairheller DL, Smith M, Carty M, Reeve EH. Blood pressure surge with alarm is reduced after exercise and diet intervention in firefighters. Blood Press Monit. 2023 Jun 1;28(3):134-143. doi: 10.1097/MBP.0000000000000649. Epub 2023 Apr 12. PubMed 37070561 ↗
  • McLaughlin KC, Perez AN, Donahue S, Feairheller DL. Tactical Circuit Training Improves Blood Pressure and Vascular Health More Than Resistance Training. Int J Exerc Sci. 2021 Nov 1;14(3):1320-1333. doi: 10.70252/CKXH1603. eCollection 2021. PubMed 35096239 ↗
  • Rynne PJ, Derella CC, McMorrow C, Dickinson RL, Donahue S, Almeida AA, Carty M, Feairheller DL. Blood pressure responses are dependent on call type and related to hypertension status in firefighters. Blood Press. 2023 Dec;32(1):2161997. doi: 10.1080/08037051.2022.2161997. PubMed 36597210 ↗
  • McMorrow C, Feairheller DL. Blood Pressure Responses in Firefighters: A Review. Curr Hypertens Rev. 2022;18(2):145-152. doi: 10.2174/1573402118666220103094201. PubMed 34979891 ↗
  • Derella CC, Aichele KR, Oakman JE, Cromwell CM, Hill JA, Chavis LN, Perez AN, Getty AK, Wisdo TR, Feairheller DL. Heart Rate and Blood Pressure Responses to Gear Weight Under a Controlled Workload. J Occup Environ Med. 2017 Apr;59(4):e20-e23. doi: 10.1097/JOM.0000000000000997. PubMed 28628053 ↗

Study documents

  • Protocol and statistical analysis plan · May 17, 2020
  • Informed consent form · May 17, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — data will be entered

Supporting information: Analytic code

08

Registry details

Key details

Study ID
NCT03344198
Lead sponsor
University of New Hampshire
Collaborators
American Heart Association, California State University, San Marcos
Responsible party
Deborah Feairheller (Assistant Professor, California State University, San Marcos) — Principal investigator
First posted
Nov 17, 2017
Start date
Nov 25, 2018
Primary completion
May 9, 2023
Completion
May 9, 2023
Last update
Aug 7, 2023

Study contacts

Deborah L Feairheller, PhD
principal investigator · California State University, San Marcos

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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