Hemodynamic Effects of Intermittent Pneumatic Compression for Sports (IPC)

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

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?

Study Overview

• Status: Completed
• Conditions: Sports Physical Therapy
• Intervention / Treatment: Device: Intermittent pneumatic compression (AirRelax)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Maia, Portugal, 4475-690
    • University of Maia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Measures of end-diastolic peak velocity, systolic peak velocity, heart rate, and arterial diameter will be collected for two minutes, two minutes before, at the 8th minute after the start of the IPC administration, and two minutes after the conclusion of each IPC protocol. End-diastolic peak velocity and systolic peak velocity will be measured across different phases of the IPC cycle (all cuffs inflated, half of the cuffs inflated, and all cuffs deflated). Both the athletes and assessors will be unaware of which protocol is being carried out. All protocols will be performed with participants lying down in a supine position, on a stretcher. The moderate pressure protocol applies a pressure of 80mmHg and the high pressure protocol applies a pressure of 200mmHg.	Device: Intermittent pneumatic compression (AirRelax); Moderate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs; Other Names: High pressure
Experimental: Sequence 2; Measures of end-diastolic peak velocity, systolic peak velocity, heart rate, and arterial diameter will be collected for two minutes, two minutes before, at the 8th minute after the start of the IPC administration, and two minutes after the conclusion of each IPC protocol. End-diastolic peak velocity and systolic peak velocity will be measured across different phases of the IPC cycle (all cuffs inflated, half of the cuffs inflated, and all cuffs deflated). Both the athletes and assessors will be unaware of which protocol is being carried out. All protocols will be performed with participants lying down in a supine position, on a stretcher. The moderate pressure protocol applies a pressure of 80mmHg and the high pressure protocol applies a pressure of 200mmHg.	Device: Intermittent pneumatic compression (AirRelax); Moderate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs; Other Names: High pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Maia

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: recovery; sports; intermittent pneumatic compression
• Other Study ID Numbers: 0000001231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No