Exercise & Diet Effects on CV Risk in Firefighters

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344198
• Other study ID #: 005-8242-01
• Status: Completed
• Phase: N/A
• Start date: November 25, 2018
• Est. completion date: May 9, 2023

Study information

• Verified date: August 2023
• Source: University of New Hampshire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult
• Able to Exercise

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	California State University San Marcos	San Marcos	California

Sponsors (3)

Lead Sponsor	Collaborator
University of New Hampshire	American Heart Association, California State University, San Marcos

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. eCollection 2021. — View Citation

McMorrow C, Feairheller DL. Blood Pressure Responses in Firefighters: A Review. Curr Hypertens Rev. 2022;18(2):145-152. doi: 10.2174/1573402118666220103094201. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure	Blood pressure surge response to alarm will be measured by ambulatory blood pressure monitor	Pre-Intervention (Week 0), Post-Intervention (Week 6)
Secondary	Change in vascular stiffness	Stiffness will be measured by pulse wave velocity	Pre-Intervention (Week 0), Post-Intervention (Week 6)
Secondary	Change in cardiopulmonary fitness	Fitness will be measured by treadmill test	Pre-Intervention (Week 0), Post-Intervention (Week 6)
Secondary	Change in body composition	Body composition will be measured by bioelectrical impedance	Pre-Intervention (Week 0), Post-Intervention (Week 6)
Secondary	Change in inflammation	Inflammation will be measured by assay of circulating bio-markers through blood draw.	Pre-Intervention (Week 0), Post-Intervention (Week 6)
Secondary	Change in oxidative stress	Oxidative stress will be measured by assay of circulating antioxidant bio-markers through blood draw.	Pre-Intervention (Week 0), Post-Intervention (Week 6)