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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05821270
Other study ID # UEvora approval number: 21050
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date September 1, 2023

Study information

Verified date April 2023
Source University of Évora
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A total of 18 military pilots in their tirocinium in the air force academy from the Portuguese Air Force course "Masters in Military Aeronautics: aviator pilot specialist" participated in this study. Participants were randomly assigned to yoga (intervention group) or waiting list (control group). Procedures were approved by the Évora University research ethics committee and participants will give written informed consent according to the Helsinki declaration (approval number: 21050).


Description:

A randomized, prospective, controlled trial was designed, with the participants (n=18) randomly distributed into two groups. The Control Group (n=8) will be receiving the protocolized classes from the course "Masters in Military Aeronautics: aviator pilot specialist" for 12 weeks, the Intervention Group (n=10) will receive the same course and 2 sessions per week (1h each) of the yoga classes (4). The intensity of the program (Borg rating of perceived exertion scale) will be measured. The operative performance response measurements will be collected at baseline and post-intervention. Participants will complete the following emergency protocols in a flight simulator: (1) take-off engine failure, (2) flight engine failure close to the base, (3) flight engine failure far away from the base, and (4) alternator failure. This intervention protocol was accepted by the Portuguese Airforce to be applied on Airbase 11 in Beja.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18
Est. completion date September 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - healthy military pilots in their tirocinium in the air force academy from the Portuguese Air Force course "Masters in Military Aeronautics: aviator pilot specialist Exclusion Criteria: - military pilots on active duty before or after the tirocinium; - injured military pilots; - military pilots on sudden lifestyle changes (as in: starting or quitting smoking habits; starting or quitting any kind of medication; starting a new diet)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ashtanga Vinyasa Yoga Supta
Ashtanga (asta - eight, anga - parts); Vinyasa (freely sequenced practice); Yoga (practice for evolution); Supta (closed eyes)

Locations

Country Name City State
Portugal UEvora Évora

Sponsors (1)

Lead Sponsor Collaborator
University of Évora

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Operative performance Flight times to complete tasks in the flight simulator and report from the flight simulator controler measured at 12 weeks (versus baseline values)
Primary Changes in Stress and HRV Heart rate variability measured with Polar H10 portable device measured at 12 weeks (versus baseline values)
Primary Changes in Vestibular system control responses Postural control responses through CoP displacement measured with a portable force platform Biosignals Plux with data sampled at 1000 Hz and electrode impedance below 5 kO. Preprocessing performed using the EEGLAB toolbox, which is available for use in MATLAB (The MathWorks Inc., Natick, MA). Data downsampled to 100 Hz. measured at 12 weeks (versus baseline values)
Secondary Changes in Body composition Body composition data (percent body fat, percent fat free mass, percent muscle mass index, as a percentages) measured with a Tanita (MC-780 MA, Tanita, Tokyo, Japan) to get a bioelectrical impedance analysis (BIA) will indicate if the exercise protocol had any impact in the pilot's physical makeup.
Percent body fat, percent fat-free mass, and percent muscle mass index are all related to body composition. Here's how they relate to each other: Percent body fat is the percentage of body weight that is made up of fat and includes both essential and storage fat; Percent fat-free mass is the percentage of body weight that is not fat and includes muscle, bone, organs, and other non-fat tissues; Percent muscle mass index is the percentage of body weight that is muscle. Percent body fat and percent fat-free mass are complementary measures that add up to 100%, while percent muscle mass index is a measure of the proportion of muscle in the body weight.
measured at 12 weeks (versus baseline values)
Secondary Changes in Lung capacity Ventilatory response measured with spirometry - FEV1/FVC ratio indicates how much air you can forcefully exhale measured at 12 weeks (versus baseline values)
Secondary Five Facet Mindfulness Questionnaire - Changes in cognitive habilities FFMQ with 15 questions and average scores are calculated by summing the responses and dividing by the number of items, and indicate the average level of agreement with the each subscale (1 = rarely true, 5 = always true). Higher scores are indicative of someone who is more mindful in their everyday life. measured at 12 weeks (versus baseline values)
Secondary Multidimensional Assessment of Interoceptive Awareness Questionnaire - Changes in cognitive habilities MAIA - is an 8-scale state-trait questionnaire with 32 items to measure multiple dimensions of interoception; scores are between 0 and 5, where higher score equates to more awareness of bodily sensation. measured at 12 weeks (versus baseline values)
Secondary Aviation Safety Attitude Scale - Changes in cognitive habilities ASAS - consists of. 27 items on a five-point scale, each designed specifically to assess pilots' attitudes with respect to predict the hazardous event involvement of aviators; For all the attitude subscales, higher scores indicate a greater degree of that particular attitude - For example, higher scores on the ASAS self-confidence factor indicated that the person expressed greater confidence in their ability as a pilot measured at 12 weeks (versus baseline values)
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