- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06253026
Fatigue in Air Search and Rescue Missions
February 9, 2024 updated by: Faculdade de Motricidade Humana
Physiological, Psychological and Cognitive Impact of Air Search and Rescue Missions
The purpose of this observational study is to understand and evaluate the physiological, psychological, and cognitive impact of 15 consecutive days of air search and rescue mission deployments on Portuguese Air Force crews.
The main goals are: 1) Characterize and compare the body composition, cardiorespiratory fitness, and strength levels of air force search and rescue mission crew members with different tasks; 2) Characterize the physiological, psychological and cognitive impacts induced by a single deployment; 3) Identify possible cumulative effects of successive deployments on the variables of interest; 3) Characterize the changes in lifestyle, quality of sleep and nutrition induced by the deployments.
The participants will be evaluated after a period of hollidays, before missions, during missions, upon arrival, for a period of twelve months, and at the end of twelve months.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Fatigue, especially in its mental and physical forms, impacts aviation performance and can result from sleep deprivation, prolonged wakefulness, changes in the circadian cycle and eating patterns, or excessive workload.
The Air Force's multidisciplinary teams deployed to complex missions, where physical and mental demands are known to be different between each operational element, face the need for diligence and efficiency to avoid errors that could result in fatal consequences.
Physical and mental recovery becomes crucial for optimal performance in missions that require precision, physical robustness and mental acuity.
Furthermore, fatigue can have long-term health effects, associated with reduced work capacity and possibly depression and anxiety.
Understanding the physiological and psychological impact of each mission highlights the need for corrective and preventative measures to increase success and safety.
The objective of the present study is to understand and evaluate the physiological, psychological and cognitive impacts after deployment missions on Portuguese Air Force personnel.
Both ground personnel and air search and rescue mission crews will be evaluated after a period of holidays (baseline).
During twelve months, when participants are recruited for missions, assessments will occur at three points: pre-mission, during the mission and post-mission.
Twelve months after the first assessment (final), all personnel will be evaluated again.
Pre-mission assessments will take place during the week prior to departure for the mission.
Baseline, final and pre-mission assessments will include anthropometric measurements, assessment of body composition and water compartments, cardiorespiratory, balance and strength tests, cognitive performance, well-being, sleep quality, food intake, psychological tests, and blood biochemical analyses.
During the mission, food intake and sleep quality will be monitored.
The post-mission assessment that will be carried out upon arrival will only include water compartment assessment, strength tests, cognitive performance, well-being, psychological tests, and blood biochemical analysis.
Statistical analysis will be performed using IBM SPSS Statistics software (version 28.0, NY, IBM).
Descriptive analyzes will be carried out to characterize the sample.
Normality for each variable of interest will be tested with the Kolmogorov-Smirnov test.
Either the paired t test or the Wilcoxon test will be used to assess the effect of each 15-day mission (pre vs post).
ANOVA for repeated measures (2x2) will be used to assess the cumulative effect of the missions (baseline vs final and ground personnel vs air personnel).
A statistical significance of α = p<0.05
will be considered.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cristina Monteiro, PhD
- Phone Number: 00351214149174
- Email: cmonteiro@fmh.ulisboa.pt
Study Contact Backup
- Name: Maria João Valamatos, PhD
- Phone Number: 00351214149174
- Email: mjvalamatos@fmh.ulisboa.pt
Study Locations
-
-
-
Lisbon, Portugal, 1495-002 Cruz-Quebrada
- Recruiting
- Faculty of Human Kinetics
-
Contact:
- Maria João Valamatos, PhD
- Phone Number: 00351214149174
- Email: mjvalamatos@fmh.ulisboa.pt
-
Contact:
- Cristina P Monteiro, PhD
- Phone Number: 00351214149174
- Email: cmonteiro@fmh.ulisboa.pt
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Military crews composed by pilot, co-pilot, nurse, host-operator, rescue diver.
Land military personal involved in desk tasks.
Description
Inclusion Criteria:
- Air Force Military
For intervention group
- Approved for search and rescue missions by the clinical staff
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Air mission personnel
Military crew that goes to air search and rescue missions in groups of five
|
Air search and rescue missions lasting 15 consecutive days
|
Control
Ground military personnel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Well-being Index
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Numeric scale (0-28).
A lower score is associated with a better result
|
Every 15 days search and rescue mission, up to 1 year
|
Changes in response inhibition (go/no go test)
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Number of errors, reaction time (ms)
|
Every 15 days search and rescue mission, up to 1 year
|
Change in response inhibition (Stroop test)
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Number of errors, reaction time (ms)
|
Every 15 days search and rescue mission, up to 1 year
|
Change of heart rate variability
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
bpm, rr interval
|
Every 15 days search and rescue mission, up to 1 year
|
Change of double task ability
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
walking and calculating
|
Every 15 days search and rescue mission, up to 1 year
|
Change of maximal voluntary strength
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
N
|
Every 15 days search and rescue mission, up to 1 year
|
Change of maximal Hand Grip strength
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
N
|
Every 15 days search and rescue mission, up to 1 year
|
Peak tork of extensors and flexors of the tight
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Peak tork
|
Every 15 days search and rescue mission, up to 1 year
|
Isometric mid-tight pull
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
maximal tork
|
Every 15 days search and rescue mission, up to 1 year
|
VO2max
Time Frame: 1 year
|
Indirect calorimetry (mL/kg/min)
|
1 year
|
Hematological indicators (hematocrit)
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Percentage (volume/volume) of red blood cell in total blood
|
Every 15 days search and rescue mission, up to 1 year
|
Hematological indicators (hemoglobin)
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
grams/mL blood
|
Every 15 days search and rescue mission, up to 1 year
|
Hematological indicators (cell counts)
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Number of red and white cells per mL of total blood
|
Every 15 days search and rescue mission, up to 1 year
|
Possible perturbations diagnosis
Time Frame: 1 year
|
Psychology clinical interview
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body mass BIA
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
body mass (kg)
|
Every 15 days search and rescue mission, up to 1 year
|
Change in fat-free mass BIA
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Fat-free mass (kg)
|
Every 15 days search and rescue mission, up to 1 year
|
Change in fat mass BIA
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Fat mass (kg)
|
Every 15 days search and rescue mission, up to 1 year
|
Change in total water BIA
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Total water (kg)
|
Every 15 days search and rescue mission, up to 1 year
|
Change in intracellular water BIA
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Intracellular water (kg), extracellular water (kg)
|
Every 15 days search and rescue mission, up to 1 year
|
Change in extracellular water BIA
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Extracellular water (kg)
|
Every 15 days search and rescue mission, up to 1 year
|
Change in center of pressure
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
cm
|
Every 15 days search and rescue mission, up to 1 year
|
Change in sleep pattern, and sleep efficiency and quality of sleep
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
Sleep minutes and minutes to fall asleep
|
Every 15 days search and rescue mission, up to 1 year
|
Bone mineral content dxa
Time Frame: 1 year
|
kg
|
1 year
|
Change in eating pattern (record) calories and macros
Time Frame: Every 15 days search and rescue mission, up to 1 year
|
kcal/d
|
Every 15 days search and rescue mission, up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 2, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 21, 2023
First Submitted That Met QC Criteria
February 9, 2024
First Posted (Actual)
February 12, 2024
Study Record Updates
Last Update Posted (Actual)
February 12, 2024
Last Update Submitted That Met QC Criteria
February 9, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LabFisiolBioqFAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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