Sports Physical TherapyIPCNCT06168565
Hemodynamic Effects of Intermittent Pneumatic Compression for Sports
A study testing Intermittent pneumatic compression (AirRelax) in people with Sports Physical Therapy, run by University of Maia at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Intermittent pneumatic compression (AirRelax)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 sitePortugal
- Study dates
- 25 Aug 2023to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- more than one risk factor for thromboembolism (e.g., use of tobacco, varicose veins)
- injured athletes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Conditions
- Sports Physical Therapy
- Being tested
- Intermittent pneumatic compression (AirRelax)
- Keywords
- sports, recovery, intermittent pneumatic compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent pneumatic compression (AirRelax)Device
Also called High pressure
Moderate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Intermittent pneumatic compression (AirRelax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Assess any changes in heart rate.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start25 Aug 2023
- Primary completion25 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filipe Silvano Pinto Maia, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168565
- Sponsor's protocol ID
- 0000001231
- Acronym
- IPC
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Intermittent Pneumatic Compression for Sports: A Double-blinded Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT06168565
- Acronym / sponsor ID
- IPC / 0000001231
- Conditions
- Sports Physical Therapy
- Keywords
- sports, recovery, intermittent pneumatic compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MaiaUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: Intermittent pneumatic compression (AirRelax)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. |
| Sequence 2 | Experimental | Device: Intermittent pneumatic compression (AirRelax)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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- more than one risk factor for thromboembolism (e.g., use of tobacco, varicose veins)
- injured athletes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent pneumatic compression (AirRelax)Also: High pressureModerate pressure (around 80mmHg); high pressure (around 200mmHg), both applied on the lower-limbs | Device | Sequence 1, Sequence 2 |
Primary outcome
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
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
Related trials for Sports Physical Therapy
Recruiting
Effects of Scapular Training on Adolescent Boxers
Sports Physical Therapy
Recruiting
Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Recruiting
French Contrast Versus Oregon Circuit Training in Competitive Football Players
No Disease or Condition is Being Studied
Recruiting
Diaphragmatic Facilitation and Upper Extremity Performance in Volleyball Players
Volleyball Players
Recruiting
Comparative Effects of Dolphin Kick Streamline Training Versus Flutter Kick Training in Competitive Swimmers
Sports Physical Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent pneumatic compression (AirRelax) in people with Sports Physical Therapy, run by University of Maia at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.