Trial Title:
Effect on Markers of Cardiovascular, Reproductive and Cancer Risk From Firefighting Training
NCT ID:
NCT05753254
Condition:
Reactive Hyperemia
Micro RNA
Heart Rate Variability
DNA Strand Breaks
Oxidative Stress
Heat Stress
Conditions: Official terms:
Hyperemia
Conditions: Keywords:
Comet assay
8-oxodG
PAH CALUX
hydroxyl-PAHs and nitro-PAH metabolites
microRNA
AhR activation
scrotal temperature
core body temperature
urine
serum
blood
follicle-stimulating hormone
inhibin B
EndoPAT
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
Participants will perform firefighting full day exercises under 3 different conditions
(without fire, under wood fire and under gas fire), sessions which will occur with weeks
in between, and biological markers will be assessed and compared in relation to a
baseline session, where the participants are having theoretical classes.
Primary purpose:
Basic Science
Masking:
Single (Outcomes Assessor)
Masking description:
It is not possible to blind the participants to the different scenarios, neither the
field staff, but all the samples will be blinded for the subsequent laboratory analysis,
namely blood analysis, urine analysis, wipe samples analysis will all be blinded.
Intervention:
Intervention type:
Other
Intervention name:
Firefighting training exercises with no fire
Description:
The participants will be performing firefighting equivalent work in a clean environment,
without fire (no ambient temperature, soot or smoke).
Arm group label:
Firefighting exercises without fire
Intervention type:
Other
Intervention name:
Firefighting training exercises under wood fire
Description:
The participants will be in teams performing pre-defined tasks (knocking down the fire,
moving heavy objects, and searching and rescuing metal stand in models), under wood fire
conditions.
Arm group label:
Firefighting under wood fire
Intervention type:
Other
Intervention name:
Firefighting training exercises under gas fire
Description:
The participants will be in teams performing pre-defined tasks (knocking down the fire,
moving heavy objects, and searching and rescuing metal stand in models), under gas fire
conditions.
Arm group label:
Firefighting under gas fire
Summary:
Epidemiological studies based on Danish registries have observed that Danish male
firefighters have more cardiovascular disease, infertility diagnose and a trend to
increased risk of cancer than other Danish employed males. Firefighting activities
include a combination of stressors such as strenuous work under heat, smoke and soot
known to be able to affect cardiovascular and reproductive health, with smoke and soot
also being known to increase the risk of cancer.
The training facilities of real-fire extinguishing exercises in Denmark operate using
wood or natural gas fire, which will have differential gradients of smoke, soot and
possibly heat. The investigators will use different training conditions to create
gradients of the different stressors and investigate health effects thereof. With this
approach, the investigators expect to be able to evaluate the individual contribution of
the different stressors in markers of cardiovascular, cancer and reproductive health
risk. The project will include approx. 35 young conscript participants on a firefighting
course, followed in four sessions, three firefighting training sessions under different
fire conditions (no fire, wood fire and gas fire) and one control scenario.
Detailed description:
The study methodology is based on a crossover design on firefighting training under
different conditions, with characterization of exposure and assessment of cardiovascular,
cancer and reproductive effect biomarkers. The study will be performed in cooperation
with the Danish Emergency Management Agency.
The study will have one baseline session, while conscripts are in a classroom, and three
sessions of firefighting-related exercises under different fire conditions, used
currently in firefighting training programs in Denmark. The three firefighting training
sessions will be controlled for equivalent work exercise using full protective gear and
under different ambient conditions of firefighting training:
- Firefighting equivalent work (no fire), with exercises performed in a clean
environment, without fire (no ambient temperature, soot or smoke). This type of
exercise precedes or complements the training under real fire conditions.
- Firefighting under wood fire (wood fire), with exposure to ambient heat, smoke and
soot. This is the most common training scenario used by Danish Emergency Management
Agency training centres.
- Firefighting under gas fire (gas fire), with exposure to ambient heat, and
expectably less smoke and soot than with wood fire. These conditions are used in
some Danish training centres, with logistical advantages (ease of turning or putting
out the fire and managing the fire fuel) and unknown effect relating to exposure
prevention (smoke and soot).
The order of the firefighting sessions will be as randomized as possible, and according
to a selection of three sequence order options (no-wood-gas; wood-gas-no and
gas-wood-no). Each campaign (corresponding to each rescue course) would desirably have
one of these session sequences. It is not possible to blind the participants to the
different scenarios, neither the field staff, but all the samples will be blinded for the
subsequent laboratory analysis. The training sessions will have 1-3 weeks in between
(accordingly with programmatic educational course schemes).
Criteria for eligibility:
Criteria:
The participants will be volunteers (both males and females) recruited among conscripts
in training in a desirable involved group up to 35 individuals.
Inclusion Criteria:
- legally competent,
- conscript subjects following a Rescue Specialist Educational course
Exclusion Criteria:
- current smoking status,
- pregnancy,
- on prescribed medication,
- body mass index (BMI) bellow 19 or over 30,
- alcohol or drug abuse.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The National Research Centre for the Working Environment
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Maria Helena G Andersen, PhD
Phone:
+45 2020 9222
Email:
mga@nfa.dk
Contact backup:
Last name:
Anne T Saber, PhD
Phone:
+45 2025 8094
Email:
ats@nfa.dk
Facility:
Name:
Maria Helena Guerra Andersen
Address:
City:
København Ø
Zip:
4700
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Maria Helena Guerra Andersen
Phone:
+4520209222
Email:
mga@nfa.dk
Start date:
March 10, 2023
Completion date:
June 2024
Lead sponsor:
Agency:
National Research Centre for the Working Environment, Denmark
Agency class:
Other
Collaborator:
Agency:
University of Copenhagen
Agency class:
Other
Collaborator:
Agency:
University Hospital Bispebjerg and Frederiksberg
Agency class:
Other
Collaborator:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Source:
National Research Centre for the Working Environment, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05753254
