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Completed

NCT Number: NCT06168565

Hemodynamic Effects of Intermittent Pneumatic Compression for Sports

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?

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Key information

Conditions

Sports Physical Therapy

Age range

18 year–26 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Maia

Maia, 4475-690, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent pneumatic compression (AirRelax)

Device

Moderate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs

Other names: High pressure

Primary outcomes

  1. Arterial Diameter

    Time frame: 2 minutes before the IPC protocol, during (8th minute mark), and 2 minutes after the conclusion of the 15 minute protocol.

    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. End-diastolic peak velocity

    Time frame: 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.

    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.

  3. Systolic peak velocity

    Time frame: 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 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.

Secondary outcomes

  1. Heart rate

    Time frame: 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.

    Assess any changes in heart rate.

Sponsors and collaborators

Lead sponsor

University of Maia

Other

Registry information

Official study title

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

Acronym: IPC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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