Fatigue Syndrome, ChronicNCT06253026
Fatigue in Air Search and Rescue Missions
An observational study of Fatigue Syndrome, Chronic, run by Faculdade de Motricidade Humana at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue Syndrome, Chronic
- What is being tested?
- Search and rescue mission
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 2 May 2023to Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Military crews composed by pilot, co-pilot, nurse, host-operator, rescue diver. Land military personal involved in desk tasks.
Who may be able to join
- Air Force Military
- For intervention group
- Approved for search and rescue missions by the clinical staff
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Human Kinetics
Lisbon, 1495-002 Cruz-Quebrada
Cristina P Monteiro, PhD, 00351214149174, cmonteiro@fmh.ulisboa.pt
Maria João Valamatos, PhD, 00351214149174, mjvalamatos@fmh.ulisboa.pt
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatigue Syndrome, Chronic
- Being tested
- Search and rescue mission
- Keywords
- Fatigue, Strength, Sleep pattern, Cognition
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Search and rescue missionOther
Air search and rescue missions lasting 15 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Air mission personnel | Military crew that goes to air search and rescue missions in groups of five Receives: Other: Search and rescue mission | |
| Control | Ground military personnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Well-being Index
Numeric scale (0-28). A lower score is associated with a better result
Measured: Every 15 days search and rescue mission, up to 1 year
Changes in response inhibition (go/no go test)
Number of errors, reaction time (ms)
Measured: Every 15 days search and rescue mission, up to 1 year
Change in response inhibition (Stroop test)
Number of errors, reaction time (ms)
Measured: Every 15 days search and rescue mission, up to 1 year
Change of heart rate variability
bpm, rr interval
Measured: Every 15 days search and rescue mission, up to 1 year
Change of double task ability
walking and calculating
Measured: Every 15 days search and rescue mission, up to 1 year
Change of maximal voluntary strength
N
Measured: Every 15 days search and rescue mission, up to 1 year
Change of maximal Hand Grip strength
N
Measured: Every 15 days search and rescue mission, up to 1 year
Peak tork of extensors and flexors of the tight
Peak tork
Measured: Every 15 days search and rescue mission, up to 1 year
Isometric mid-tight pull
maximal tork
Measured: Every 15 days search and rescue mission, up to 1 year
VO2max
Indirect calorimetry (mL/kg/min)
Measured: 1 year
Hematological indicators (hematocrit)
Percentage (volume/volume) of red blood cell in total blood
Measured: Every 15 days search and rescue mission, up to 1 year
Hematological indicators (hemoglobin)
grams/mL blood
Measured: Every 15 days search and rescue mission, up to 1 year
Hematological indicators (cell counts)
Number of red and white cells per mL of total blood
Measured: Every 15 days search and rescue mission, up to 1 year
Possible perturbations diagnosis
Psychology clinical interview
Measured: 1 year
Secondary outcomes (10)
Change in body mass BIA
body mass (kg)
Measured: Every 15 days search and rescue mission, up to 1 year
Change in fat-free mass BIA
Fat-free mass (kg)
Measured: Every 15 days search and rescue mission, up to 1 year
Change in fat mass BIA
Fat mass (kg)
Measured: Every 15 days search and rescue mission, up to 1 year
Change in total water BIA
Total water (kg)
Measured: Every 15 days search and rescue mission, up to 1 year
Change in intracellular water BIA
Intracellular water (kg), extracellular water (kg)
Measured: Every 15 days search and rescue mission, up to 1 year
Change in extracellular water BIA
Extracellular water (kg)
Measured: Every 15 days search and rescue mission, up to 1 year
Change in center of pressure
cm
Measured: Every 15 days search and rescue mission, up to 1 year
Change in sleep pattern, and sleep efficiency and quality of sleep
Sleep minutes and minutes to fall asleep
Measured: Every 15 days search and rescue mission, up to 1 year
Bone mineral content dxa
kg
Measured: 1 year
Change in eating pattern (record) calories and macros
kcal/d
Measured: Every 15 days search and rescue mission, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start2 May 2023
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Syndrome, ChronicStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Collaborators
- CIDEFES - Universidade Lusofona, Força Aerea Portuguesa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253026
- Sponsor's protocol ID
- LabFisiolBioqFAP
- Status last verified
- Feb 2024
- First submitted
- 21 Dec 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological, Psychological and Cognitive Impact of Air Search and Rescue Missions
- ClinicalTrials.gov ID
- NCT06253026
- Acronym / sponsor ID
- LabFisiolBioqFAP
- Conditions
- Fatigue Syndrome, Chronic
- Keywords
- Fatigue, Strength, Sleep pattern, Cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Collaborators
- CIDEFES - Universidade Lusofona, Força Aerea Portuguesa
- Study start
- 2 May 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Feb 2024 (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 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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air mission personnel | – | Other: Search and rescue missionMilitary crew that goes to air search and rescue missions in groups of five |
| Control | – | –Ground military personnel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Military crews composed by pilot, co-pilot, nurse, host-operator, rescue diver. Land military personal involved in desk tasks.
Key inclusion criteria (3 listed)
- Air Force Military
- For intervention group
- Approved for search and rescue missions by the clinical staff
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Search and rescue missionAir search and rescue missions lasting 15 consecutive days | Other | Air mission personnel |
Primary outcome
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
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)
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)
Change of heart rate variability
Time frame: Every 15 days search and rescue mission, up to 1 year
bpm, rr interval
Change of double task ability
Time frame: Every 15 days search and rescue mission, up to 1 year
walking and calculating
Change of maximal voluntary strength
Time frame: Every 15 days search and rescue mission, up to 1 year
N
Change of maximal Hand Grip strength
Time frame: Every 15 days search and rescue mission, up to 1 year
N
Peak tork of extensors and flexors of the tight
Time frame: Every 15 days search and rescue mission, up to 1 year
Peak tork
Isometric mid-tight pull
Time frame: Every 15 days search and rescue mission, up to 1 year
maximal tork
VO2max
Time frame: 1 year
Indirect calorimetry (mL/kg/min)
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
Hematological indicators (hemoglobin)
Time frame: Every 15 days search and rescue mission, up to 1 year
grams/mL blood
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
Possible perturbations diagnosis
Time frame: 1 year
Psychology clinical interview
10 secondary outcomes
Change in body mass BIA
Time frame: 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
Change in fat mass BIA
Time frame: 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
Change in intracellular water BIA
Time frame: 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
Change in center of pressure
Time frame: 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
Bone mineral content dxa
Time frame: 1 year
Change in eating pattern (record) calories and macros
Time frame: Every 15 days search and rescue mission, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue Syndrome, Chronic, run by Faculdade de Motricidade Humana at 1 site in Portugal.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Monteiro, PhD (00351214149174, cmonteiro@fmh.ulisboa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Well-being Index (time frame: Every 15 days search and rescue mission, up to 1 year). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2024.