Hemodynamic Effects of Intermittent Pneumatic Compression for Sports

Study Overview
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Brief Summary
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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?

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

Conditions
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Sports Physical Therapy

Intervention / Treatment
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* Device: Intermittent pneumatic compression (AirRelax)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>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)<br>* Moderate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs<br>* Other names: High pressure;|
| Experimental: Sequence 2<br>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)<br>* Moderate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs<br>* Other names: High pressure;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sports, recovery, intermittent pneumatic compression