Cardiovascular Risk FactorNCT03344198
Exercise & Diet Effects on CV Risk in Firefighters
A study testing Circuit Training exercise & Modified Mediterranean diet in people with Cardiovascular Risk Factor and Blood Pressure, run by University of New Hampshire at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Blood Pressure, Exercise
- What is being tested?
- Circuit Training exercise & Modified Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2018to 9 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult
- Able to Exercise
Who cannot join
- More than one anti-hypertensive medication
- More than one cholesterol medication
- Diabetic
- Prior Cardiac incident
Trial locations and contacts
1 site in 1 country.
United States1 site
California State University San Marcos
San Marcos, California, 92096
About this study
Official title: 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.
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.
- Being tested
- Circuit Training exercise & Modified Mediterranean diet
- Keywords
- Cardiovascular Disease, Mediterranean Diet, Exercise Training, Blood Pressure
- Medical subject headings
- Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit Training exercise & Modified Mediterranean dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Firefighter (Veteran) Group | Experimental | Firefighters with >10yrs experience. Circuit Training exercise \& Modified Mediterranean diet Receives: Behavioral: Circuit Training exercise & Modified Mediterranean diet |
| Firefighter (Novice) Group | Experimental | Firefighters with <10yrs experience. Circuit Training exercise \& Modified Mediterranean diet Receives: Behavioral: Circuit Training exercise & Modified Mediterranean diet |
| Control Non-Firefighter Group | Experimental | Non-Firefighter adults. Circuit Training exercise \& Modified Mediterranean diet Receives: Behavioral: Circuit Training exercise & Modified Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Blood pressure surge response to alarm will be measured by ambulatory blood pressure monitor
Measured: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Secondary outcomes (5)
Change in vascular stiffness
Stiffness will be measured by pulse wave velocity
Measured: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in cardiopulmonary fitness
Fitness will be measured by treadmill test
Measured: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in body composition
Body composition will be measured by bioelectrical impedance
Measured: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in inflammation
Inflammation will be measured by assay of circulating bio-markers through blood draw.
Measured: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in oxidative stress
Oxidative stress will be measured by assay of circulating antioxidant bio-markers through blood draw.
Measured: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start25 Nov 2018
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, California State University, San Marcos
- Responsible party
- Principal investigator, Deborah Feairheller, California State University, San Marcos
- Investigators
- Deborah L Feairheller, PhD, Principal investigator, California State University, San Marcos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344198
- Sponsor's protocol ID
- 005-8242-01
- Status last verified
- Aug 2023
- First submitted
- 24 Oct 2017
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be entered
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 35734390Almeida 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 34985026Feairheller 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 37070561McLaughlin 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 35096239Rynne 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 36597210McMorrow C, Feairheller DL. Blood Pressure Responses in Firefighters: A Review. Curr Hypertens Rev. 2022;18(2):145-152. doi: 10.2174/1573402118666220103094201.
PubMed 34979891Derella 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 at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Diet & Exercise Intervention on Cardiovascular Risk Factors in Firefighters & Civilians
- ClinicalTrials.gov ID
- NCT03344198
- Acronym / sponsor ID
- 005-8242-01
- Keywords
- Cardiovascular Disease, Mediterranean Diet, Exercise Training, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Collaborators
- American Heart Association, California State University, San Marcos
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Firefighter (Veteran) Group | Experimental | Behavioral: Circuit Training exercise & Modified Mediterranean dietFirefighters with >10yrs experience. Circuit Training exercise \& Modified Mediterranean diet |
| Firefighter (Novice) Group | Experimental | Behavioral: Circuit Training exercise & Modified Mediterranean dietFirefighters with <10yrs experience. Circuit Training exercise \& Modified Mediterranean diet |
| Control Non-Firefighter Group | Experimental | Behavioral: Circuit Training exercise & Modified Mediterranean dietNon-Firefighter adults. Circuit Training exercise \& Modified Mediterranean diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult
- Able to Exercise
Key exclusion criteria (4 listed)
- More than one anti-hypertensive medication
- More than one cholesterol medication
- Diabetic
- Prior Cardiac incident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circuit Training exercise & Modified Mediterranean dietParticipants 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. | Behavioural | Control Non-Firefighter Group, Firefighter (Novice) Group, Firefighter (Veteran) Group |
Primary outcome
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
5 secondary outcomes
Change in vascular stiffness
Time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in cardiopulmonary fitness
Time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in body composition
Time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in inflammation
Time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Change in oxidative stress
Time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 35734390Donahue 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.
- Background: PubMed 34985026Almeida 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.
- Background: PubMed 37070561Feairheller 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.
- Background: PubMed 35096239McLaughlin 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.
- Background: PubMed 36597210Rynne 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.
- Background: PubMed 34979891McMorrow C, Feairheller DL. Blood Pressure Responses in Firefighters: A Review. Curr Hypertens Rev. 2022;18(2):145-152. doi: 10.2174/1573402118666220103094201.
- Background: PubMed 28628053Derella 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.
- Individual participant dataSharing planned: Yes. data will be entered
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah L Feairheller, PhD principal investigator
California State University, San Marcos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit Training exercise & Modified Mediterranean diet in people with Cardiovascular Risk Factor and Blood Pressure, run by University of New Hampshire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Pre-Intervention (Week 0), Post-Intervention (Week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344198, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.