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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06168565
Other study ID # 0000001231
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 25, 2023
Est. completion date September 27, 2023

Study information

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

Clinical Trial Summary

The aim of this randomized crossover trial is to assess the hemodynamic effects caused by the use of 2 distinct intermittent pneumatic compression protocols on athletes. The main questions it aims to answer are: - Does intermittent pneumatic compression enhance athletes blood flow? - If yes, what pressure is better to cause this enhancement?


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date September 27, 2023
Est. primary completion date September 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria: - male gender - healthy - competing in soccer of track and field for at least two years - not have performed any physical activity on the data collection day Exclusion Criteria: - more than one risk factor for thromboembolism (e.g., use of tobacco, varicose veins) - injured athletes

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Intermittent pneumatic compression (AirRelax)
Moderate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs

Locations

Country Name City State
Portugal University of Maia Maia

Sponsors (1)

Lead Sponsor Collaborator
University of Maia

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial Diameter Assessment of arterial diameter via automatic edge detection software (FMD Studio, Pisa, Italy) measuring the distance between the near and far wall of the intima 2 minutes before the IPC protocol, during (8th minute mark), and 2 minutes after the conclusion of the 15 minute protocol.
Primary End-diastolic peak velocity End-diastolic peak velocity will be assessed in a supine position on the right common femoral artery using an ultrasound (Logiq e BT12; General Electric, Fairfield, CT, USA) with a 3 to 12 MHz multi-frequency linear phase array transducer. 2 minutes before the IPC protocol, during (8th minute mark - at different phases of the IPC cycle), and 2 minutes after the conclusion of the 15 minute protocol.
Primary Systolic peak velocity Systolic peak velocity will be assessed in a supine position on the right common femoral artery using an ultrasound (Logiq e BT12; General Electric, Fairfield, CT, USA) with a 3 to 12 MHz multi-frequency linear phase array transducer. 2 minutes before the IPC protocol, during (8th minute mark - at different phases of the IPC cycle), and 2 minutes after the conclusion of the 15 minute protocol.
Secondary Heart rate Assess any changes in heart rate. 2 minutes before the IPC protocol, during (8th minute mark - at different phases of the IPC cycle), and 2 minutes after the conclusion of the 15 minute protocol.
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