Hemodynamic Effects of Intermittent Pneumatic Compression for Sports

NCT06168565 | Completed

• 1 other identifier: 0000001231
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Sports Physical Therapy

Keywords

sports; recovery; intermittent pneumatic compression

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Sequence 1

EXPERIMENTAL

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)

Sequence 2

EXPERIMENTAL

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)

Interventions

Intermittent pneumatic compression (AirRelax) DEVICE

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

Also known as: High pressure

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 26 Years
• Gender Eligibility Details: Male gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• more than one risk factor for thromboembolism (e.g., use of tobacco, varicose veins)
• injured athletes

Sponsors & Collaborators

• University of Maia: lead

Study Sites (1)

University of Maia

Maia, 4475-690, Portugal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 13, 2023
• Study Start: August 25, 2023
• Primary Completion: September 25, 2023
• Study Completion: September 27, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

PT (1)