Clinical trial NCT06253026: Fatigue in Air Search and Rescue Missions
Official title: Physiological, Psychological and Cognitive Impact of Air Search and Rescue Missions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fatigue Syndrome, Chronic
Keywords: Fatigue
Strength
Sleep pattern
Cognition
Lead sponsor: Faculdade de Motricidade Humana
Sponsor class: OTHER
Collaborators: name: CIDEFES - Universidade Lusofona
name: Força Aerea Portuguesa
First posted: 2024-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Air Force Military

For intervention group

* Approved for search and rescue missions by the clinical staff

Primary outcomes:
measure: Change of Well-being Index
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Changes in response inhibition (go/no go test)
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change in response inhibition (Stroop test)
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change of heart rate variability
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change of double task ability
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change of maximal voluntary strength
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change of maximal Hand Grip strength
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Peak tork of extensors and flexors of the tight
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Isometric mid-tight pull
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: VO2max
timeFrame: 1 year
measure: Hematological indicators (hematocrit)
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Hematological indicators (hemoglobin)
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Hematological indicators (cell counts)
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Possible perturbations diagnosis
timeFrame: 1 year
Secondary outcomes:
measure: Change in body mass BIA
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change in fat-free mass BIA
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change in fat mass BIA
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change in total water BIA
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change in intracellular water BIA
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change in extracellular water BIA
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change in center of pressure
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Change in sleep pattern, and sleep efficiency and quality of sleep
timeFrame: Every 15 days search and rescue mission, up to 1 year
measure: Bone mineral content dxa
timeFrame: 1 year
measure: Change in eating pattern (record) calories and macros
timeFrame: Every 15 days search and rescue mission, up to 1 year
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Faculty of Human Kinetics
Study officials:
References: