Sports Physical TherapyIPC4sportsNCT06201260
Effects of Intermittent Pneumatic Compression Following Exercise-induced Muscle Damaged
A study testing intermittent pneumatic compression protocol in people with Sports Physical Therapy, run by University of Maia at 1 site in Portugal.
Trial summary
This study aims to assess the recovery kinetics following an exercise-induced muscle damage activity (using flywheel) on active healthy university students. The main questions are: Is intermittent pneumatic compression superior to a placebo recovering from EIMD? Participants will perform a fatiguing protocol using… Read more about this study
- Who is it for?
- Ages 18 to 27 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- intermittent pneumatic compression protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Feb 2024to 15 Mar 2024
- 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 27 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible for participating in this study, participants should not have been recently injured, and should engage physical activity regularly (>3 times/week).
Who cannot join
- Inactive participants
- Younger than 18 years old or older than 27 years old
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the recovery kinetics following an exercise-induced muscle damage activity (using flywheel) on active healthy university students.
The main questions are:
- Is intermittent pneumatic compression superior to a placebo recovering from EIMD? Participants will perform a fatiguing protocol using flywheel and recover with either intermittent pneumatic compression or with a placebo treatment (micro-current treatment, but the device turned off). They will perform several performance tests before, following the recovery period, and at the 24h and 48h following the intervention
- Conditions
- Sports Physical Therapy
- Being tested
- intermittent pneumatic compression protocol, Placebo treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent pneumatic compression protocolOther
A 30 min IPC protocol at about 200mmHg
Placebo treatmentOther
The electrodes of an electrostimulation device (SP 4.0, Compex, Guildford, United Kingdom) will be positioned on participants' quadriceps. Participants will be informed that they are engaging an innovative microcurrent treatment. This procedure will last for 30 min.
| Study group | Role | What they receive |
|---|---|---|
| IPC | Experimental | a 30 min high-pressure IPC protocol Receives: Other: intermittent pneumatic compression protocol |
| placebo | Placebo comparator | A 30 min placebo Receives: Other: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary contraction (knee extension)
Measures of isometric strength
Measured: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Countermovement jump
Jump height
Measured: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Broad Jump
Horizontal jump
Measured: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Soreness scale
Likert scale of muscle soreness - the scale ranges from from 0 (a complete absence of soreness) to 6 (a severe pain that limits the ability to move)
Measured: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Feb 2024
- Primary completion15 Feb 2024
- Study completion15 Mar 2024
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 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
- NCT06201260
- Sponsor's protocol ID
- PDFM_003
- Other IDs
- IPC
- Acronym
- IPC4sports
- Status last verified
- May 2024
- First submitted
- 24 Nov 2023
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Pneumatic Compression Following Exercise-induced Muscle Damaged
- ClinicalTrials.gov ID
- NCT06201260
- Acronym / sponsor ID
- IPC4sports / PDFM_003
- Conditions
- Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of MaiaUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 11 Jan 2024 (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.
This study aims to assess the recovery kinetics following an exercise-induced muscle damage activity (using flywheel) on active healthy university students.
The main questions are:
- Is intermittent pneumatic compression superior to a placebo recovering from EIMD? Participants will perform a fatiguing protocol using flywheel and recover with either intermittent pneumatic compression or with a placebo treatment (micro-current treatment, but the device turned off). They will perform several performance tests before, following the recovery period, and at the 24h and 48h following the intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPC | Experimental | Other: intermittent pneumatic compression protocola 30 min high-pressure IPC protocol |
| placebo | Placebo comparator | Other: Placebo treatmentA 30 min placebo |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be eligible for participating in this study, participants should not have been recently injured, and should engage physical activity regularly (>3 times/week).
Key exclusion criteria (2 listed)
- Inactive participants
- Younger than 18 years old or older than 27 years old
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 protocolA 30 min IPC protocol at about 200mmHg | Other | IPC |
| Placebo treatmentThe electrodes of an electrostimulation device (SP 4.0, Compex, Guildford, United Kingdom) will be positioned on participants' quadriceps. Participants will be informed that they are engaging an innovative microcurrent treatment. This procedure will last for 30 min. | Other | placebo |
Primary outcome
Maximal voluntary contraction (knee extension)
Time frame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Measures of isometric strength
Countermovement jump
Time frame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Jump height
Broad Jump
Time frame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Horizontal jump
Soreness scale
Time frame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Likert scale of muscle soreness - the scale ranges from from 0 (a complete absence of soreness) to 6 (a severe pain that limits the ability to move)
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 8 May 2024.
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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 protocol 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 1 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 8 May 2024. 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. Some participants in this study may receive a placebo. 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?
Maximal voluntary contraction (knee extension) (time frame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention). The study lists 4 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 8 May 2024.