Fatigue in Air Search and Rescue Missions

Fatigue Syndrome, Chronic Clinical Trial

Official title:

Physiological, Psychological and Cognitive Impact of Air Search and Rescue Missions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253026
• Other study ID #: LabFisiolBioqFAP
• Status: Recruiting
• Start date: May 2, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Faculdade de Motricidade Humana
• Contact: Cristina Monteiro, PhD
• Phone: 00351214149174
• Email: cmonteiro[@]fmh.ulisboa.pt
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Air Force Military

For intervention group

• Approved for search and rescue missions by the clinical staff

Related Conditions & MeSH terms

• Fatigue
• Fatigue Syndrome, Chronic

Intervention

Other:
• Search and rescue mission
Air search and rescue missions lasting 15 consecutive days

Locations

Country	Name	City	State
Portugal	Faculty of Human Kinetics	Lisbon

Sponsors (3)

Lead Sponsor	Collaborator
Faculdade de Motricidade Humana	CIDEFES - Universidade Lusofona, Força Aerea Portuguesa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Well-being Index	Numeric scale (0-28). A lower score is associated with a better result	Every 15 days search and rescue mission, up to 1 year
Primary	Changes in response inhibition (go/no go test)	Number of errors, reaction time (ms)	Every 15 days search and rescue mission, up to 1 year
Primary	Change in response inhibition (Stroop test)	Number of errors, reaction time (ms)	Every 15 days search and rescue mission, up to 1 year
Primary	Change of heart rate variability	bpm, rr interval	Every 15 days search and rescue mission, up to 1 year
Primary	Change of double task ability	walking and calculating	Every 15 days search and rescue mission, up to 1 year
Primary	Change of maximal voluntary strength	N	Every 15 days search and rescue mission, up to 1 year
Primary	Change of maximal Hand Grip strength	N	Every 15 days search and rescue mission, up to 1 year
Primary	Peak tork of extensors and flexors of the tight	Peak tork	Every 15 days search and rescue mission, up to 1 year
Primary	Isometric mid-tight pull	maximal tork	Every 15 days search and rescue mission, up to 1 year
Primary	VO2max	Indirect calorimetry (mL/kg/min)	1 year
Primary	Hematological indicators (hematocrit)	Percentage (volume/volume) of red blood cell in total blood	Every 15 days search and rescue mission, up to 1 year
Primary	Hematological indicators (hemoglobin)	grams/mL blood	Every 15 days search and rescue mission, up to 1 year
Primary	Hematological indicators (cell counts)	Number of red and white cells per mL of total blood	Every 15 days search and rescue mission, up to 1 year
Primary	Possible perturbations diagnosis	Psychology clinical interview	1 year
Secondary	Change in body mass BIA	body mass (kg)	Every 15 days search and rescue mission, up to 1 year
Secondary	Change in fat-free mass BIA	Fat-free mass (kg)	Every 15 days search and rescue mission, up to 1 year
Secondary	Change in fat mass BIA	Fat mass (kg)	Every 15 days search and rescue mission, up to 1 year
Secondary	Change in total water BIA	Total water (kg)	Every 15 days search and rescue mission, up to 1 year
Secondary	Change in intracellular water BIA	Intracellular water (kg), extracellular water (kg)	Every 15 days search and rescue mission, up to 1 year
Secondary	Change in extracellular water BIA	Extracellular water (kg)	Every 15 days search and rescue mission, up to 1 year
Secondary	Change in center of pressure	cm	Every 15 days search and rescue mission, up to 1 year
Secondary	Change in sleep pattern, and sleep efficiency and quality of sleep	Sleep minutes and minutes to fall asleep	Every 15 days search and rescue mission, up to 1 year
Secondary	Bone mineral content dxa	kg	1 year
Secondary	Change in eating pattern (record) calories and macros	kcal/d	Every 15 days search and rescue mission, up to 1 year