NCT03344198

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

November 25, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2023

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

4.5 years

First QC Date

October 24, 2017

Last Update Submit

August 2, 2023

Conditions

Keywords

Cardiovascular DiseaseMediterranean DietExercise TrainingBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in vascular stiffness

    Pre-Intervention (Week 0), Post-Intervention (Week 6)

  • Change in cardiopulmonary fitness

    Pre-Intervention (Week 0), Post-Intervention (Week 6)

  • Change in body composition

    Pre-Intervention (Week 0), Post-Intervention (Week 6)

  • Change in inflammation

    Pre-Intervention (Week 0), Post-Intervention (Week 6)

  • Change in oxidative stress

    Pre-Intervention (Week 0), Post-Intervention (Week 6)

Study Arms (3)

Firefighter (Veteran) Group

EXPERIMENTAL

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

Behavioral: Circuit Training exercise & Modified Mediterranean diet

Firefighter (Novice) Group

EXPERIMENTAL

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

Behavioral: Circuit Training exercise & Modified Mediterranean diet

Control Non-Firefighter Group

EXPERIMENTAL

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

Behavioral: Circuit Training exercise & Modified Mediterranean diet

Interventions

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.

Control Non-Firefighter GroupFirefighter (Novice) GroupFirefighter (Veteran) Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult
  • Able to Exercise

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California State University San Marcos

San Marcos, California, 92096, United States

Location

Related Publications (7)

  • 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.

    PMID: 35734390BACKGROUND
  • 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.

    PMID: 34985026BACKGROUND
  • 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.

    PMID: 37070561BACKGROUND
  • 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.

    PMID: 35096239BACKGROUND
  • 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.

    PMID: 36597210BACKGROUND
  • McMorrow C, Feairheller DL. Blood Pressure Responses in Firefighters: A Review. Curr Hypertens Rev. 2022;18(2):145-152. doi: 10.2174/1573402118666220103094201.

    PMID: 34979891BACKGROUND
  • 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.

    PMID: 28628053BACKGROUND

MeSH Terms

Conditions

Motor ActivityCardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Deborah L Feairheller, PhD

    California State University, San Marcos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 17, 2017

Study Start

November 25, 2018

Primary Completion

May 9, 2023

Study Completion

May 9, 2023

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

data will be entered

Shared Documents
ANALYTIC CODE
Time Frame
2023
Access Criteria
must get approval from PI

Locations