- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03344198
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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
- 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.
- 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.
- 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.
- 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.
- 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.
- McMorrow C, Feairheller DL. Blood Pressure Responses in Firefighters: A Review. Curr Hypertens Rev. 2022;18(2):145-152. doi: 10.2174/1573402118666220103094201.
- 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.
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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