Hemodynamic Effects of Intermittent Pneumatic Compression for Sports

Sports Physical Therapy Clinical Trial

— IPC  

Official title:

Hemodynamic Effects of Intermittent Pneumatic Compression for Sports: A Double-blinded Randomized Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06168565
• Other study ID #: 0000001231
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Sports Physical Therapy

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.