NCT06253026

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

December 21, 2023

Last Update Submit

February 9, 2024

Conditions

Keywords

FatigueStrengthSleep patternCognition

Outcome Measures

Primary Outcomes (14)

  • 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

  • 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

  • Change in response inhibition (Stroop test)

    Number of errors, reaction time (ms)

    Every 15 days search and rescue mission, up to 1 year

  • Change of heart rate variability

    bpm, rr interval

    Every 15 days search and rescue mission, up to 1 year

  • Change of double task ability

    walking and calculating

    Every 15 days search and rescue mission, up to 1 year

  • Change of maximal voluntary strength

    N

    Every 15 days search and rescue mission, up to 1 year

  • Change of maximal Hand Grip strength

    N

    Every 15 days search and rescue mission, up to 1 year

  • Peak tork of extensors and flexors of the tight

    Peak tork

    Every 15 days search and rescue mission, up to 1 year

  • Isometric mid-tight pull

    maximal tork

    Every 15 days search and rescue mission, up to 1 year

  • VO2max

    Indirect calorimetry (mL/kg/min)

    1 year

  • Hematological indicators (hematocrit)

    Percentage (volume/volume) of red blood cell in total blood

    Every 15 days search and rescue mission, up to 1 year

  • Hematological indicators (hemoglobin)

    grams/mL blood

    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

    Every 15 days search and rescue mission, up to 1 year

  • Possible perturbations diagnosis

    Psychology clinical interview

    1 year

Secondary Outcomes (10)

  • Change in body mass BIA

    Every 15 days search and rescue mission, up to 1 year

  • Change in fat-free mass BIA

    Every 15 days search and rescue mission, up to 1 year

  • Change in fat mass BIA

    Every 15 days search and rescue mission, up to 1 year

  • Change in total water BIA

    Every 15 days search and rescue mission, up to 1 year

  • Change in intracellular water BIA

    Every 15 days search and rescue mission, up to 1 year

  • +5 more secondary outcomes

Study Arms (2)

Air mission personnel

Military crew that goes to air search and rescue missions in groups of five

Other: Search and rescue mission

Control

Ground military personnel

Interventions

Air search and rescue missions lasting 15 consecutive days

Air mission personnel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Military crews composed by pilot, co-pilot, nurse, host-operator, rescue diver. Land military personal involved in desk tasks.

You may qualify if:

  • Air Force Military
  • For intervention group
  • Approved for search and rescue missions by the clinical staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Human Kinetics

Lisbon, 1495-002 Cruz-Quebrada, Portugal

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum for biochemical analysis

MeSH Terms

Conditions

Fatigue Syndrome, ChronicFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Cristina Monteiro, PhD

CONTACT

Maria João Valamatos, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2023

First Posted

February 12, 2024

Study Start

May 2, 2023

Primary Completion

May 1, 2024

Study Completion

December 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations