HealthyNCT05153980
The Impact of Blood Flow Restriction Within Warm-up.
A study testing Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet) and Warm-up in people with Healthy, run by University Ghent at 1 site in Belgium.
Trial summary
Sixty athletes will be randomized in two groups; (1) an experimental group and (2) a control group. Both groups will undergo the following procedure: Moment 1: 1. Baseline testing: countermovement jump, 25m sprint and strength assessment of the Hamstrings and Quadriceps muscle. 2. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet) and Warm-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Nov 2021to 30 Nov 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free of pain at the moment of testing
- Adult (18+)
- Athletes (competitive team sport)
Who cannot join
- History of a hamstring strain injury
- History of cardiovascular problems
- Recent (<1 year) trauma or surgery of the lower extremity
- Reduced functioning or pain in the lower extremity.
- Not being able to perform physical activities, for whatever (medical) reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Blood Flow Restriction Within Warm-up Routines on Performance and Muscle Stiffness.
Sixty athletes will be randomized in two groups; (1) an experimental group and (2) a control group. Both groups will undergo the following procedure:
Moment 1:
Read more
- Baseline testing: countermovement jump, 25m sprint and strength assessment of the Hamstrings and Quadriceps muscle.
- Short warm-up (approximately 4 minutes), which will be completed with blood flow restriction cuffs (experimental group) or without (control group)
- Post testing: same tests as performed in baseline.
Moment 2:
- Baseline testing: stiffness measurements of the Biceps Femoris Long Head via Shear Wave Elastography.
- Short warm-up (approximately 4 minutes), which will be completed with blood flow restriction cuffs (experimental group) or without (control group)
- Post testing: same tests as performed in baseline.
Both moments of testing as well as the order in which the performance tests take place are randomized.
Read the detailed description
Traditionally, athletes perform a warm-up program before participating in sport activities, due to its assumed beneficial effect on performance and injury prevention. However, within team sports, substitutes usually do not perform the comprehensive pre-match warm-up. In many cases, those substitute players get a very short period of time, during the game, to prepare themselves for coming on to the pitch where they immediately have to perform at a very high-intensity. Hence, this could lead to a poorer performance and a greater injury risk for those substitute players, as they did not get a decent warm-up.
Therefore, new techniques are needed in order to prepare the substitute athletes optimally in a very short period of time (often within a few minutes). Consequently, the aim of this study is to investigate whether the incorporation of Blood Flow Restriction (BFR) within a warm-up routine could be of additional value. Both performance parameters and muscle stiffness will be evaluated. As Hamstring strain Injuries (HSI) are common within sports encompassing high-speed running, this muscle group will be investigated on muscle stiffness as a representation of the interventional effect on muscle stiffness. Athletes will be randomized in two groups of 30 participants (anticipated); (1) an experimental group and (2) a control group. Both groups will perform baseline testing (5x Countermovement Jump, 25m Sprint and Muscle Strength of hamstrings and Quadriceps), and a short warm-up program, followed by repeating the same tests as executed in baseline. The experimental group will receive Blood Flow Restriction within the warm-up routine, whereas the control group will do the same warm up program but without BFR.
On a separate occasion, the same athletes will perform the same warm-up routine with a Shear Wave Elastographic assessment of the Biceps Femoris Long Head before and after (immediately after, after 5 minutes and once more after 10 minutes) the warm-up.
- Conditions
- Healthy
- Being tested
- Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet), Warm-up
- Keywords
- Shear Wave Elastography, Blood Flow Restriction, Warm-up, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet)Device
Also called Kaatsu, partial vascular occlusion
Blood Flow Restriction
Warm-upOther
Warm-up without any special intervention (no Blood Flow Restriction)
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction | Experimental | Incorporation of Blood Flow Restriction within the warm-up routine. Receives: Device: Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet) |
| Control Group | Active comparator | Warm-up routine without any special intervention (no Blood Flow Restriction). Receives: Other: Warm-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle stiffness
The stiffness of the Biceps Femoris Long Head of the dominant leg will be assessed via a Shear Wave Elastography Device (Mach 30, SuperSonic Imagine), before and immediately after the warm-up routine. The muscle stiffness will be expressed in Kilopascals (kPa).
Measured: (1) Before the warm-up routine, (2) immediately after the warm-up routine, (3) 5 minutes after the warm-up routine, and (4) 10 minutes after the warm-up routine
Change in jump height
The jump height will be assessed during 5 consecutive countermovement jumps. This will be assessed with an OptoJump device. The highest jump will be taken into account. The jump height will be expressed in cm.
Measured: (1) Before the warm-up routine and (2) immediately after the warm-up routine
Change in muscle strength
Muscle strength of the Hamstrings and Quadriceps muscles. Measured via a Hand Held Dynamometer. Strength will be expressed in Newton (N).
Measured: (1) Before the warm-up routine and (2) immediately after the warm-up routine
Change in sprinting speed
Sprinting speed will be assessed at 5m, 10m and 25m. This via the use of timing gates. This outcome measure will be expressed in seconds (s).
Measured: (1) Before the warm-up routine and (2) immediately after the warm-up routine
Secondary outcomes (2)
level of readiness
Participants will be asked after the warm-up (with or without BFR) how well they feel prepared to substitute into the game on a scale from 0-100; being zero = not ready at all, 100 = totally ready
Measured: Immediately after the warm-up
Change in heart rate
This parameter will be captured to track the cardiovascular answer of the body during the warm-up by using a polar watch and elastic strap with a monitor around the waist.
Measured: (1) Right before the warm up, (2) after one minute, (3) after two minutes, (4) after 3 minutes, (5) at the end of the warm up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start2 Nov 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Witvrouw, Principal investigator, Departement of Rehabilitation Sciences, Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153980
- Sponsor's protocol ID
- B6702021000931
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Blood Flow Restriction Within Warm-up Routines on Performance and Muscle Stiffness.
- ClinicalTrials.gov ID
- NCT05153980
- Acronym / sponsor ID
- B6702021000931
- Conditions
- Healthy
- Keywords
- Shear Wave Elastography, Blood Flow Restriction, Warm-up, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 10 Dec 2021 (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.
Sixty athletes will be randomized in two groups; (1) an experimental group and (2) a control group. Both groups will undergo the following procedure:
Moment 1:
- Baseline testing: countermovement jump, 25m sprint and strength assessment of the Hamstrings and Quadriceps muscle.
- Short warm-up (approximately 4 minutes), which will be completed with blood flow restriction cuffs (experimental group) or without (control group)
- Post testing: same tests as performed in baseline.
Moment 2:
- Baseline testing: stiffness measurements of the Biceps Femoris Long Head via Shear Wave Elastography.
- Short warm-up (approximately 4 minutes), which will be completed with blood flow restriction cuffs (experimental group) or without (control group)
- Post testing: same tests as performed in baseline.
Both moments of testing as well as the order in which the performance tests take place are randomized.
Detailed description
Traditionally, athletes perform a warm-up program before participating in sport activities, due to its assumed beneficial effect on performance and injury prevention. However, within team sports, substitutes usually do not perform the comprehensive pre-match warm-up. In many cases, those substitute players get a very short period of time, during the game, to prepare themselves for coming on to the pitch where they immediately have to perform at a very high-intensity. Hence, this could lead to a poorer performance and a greater injury risk for those substitute players, as they did not get a decent warm-up.
Therefore, new techniques are needed in order to prepare the substitute athletes optimally in a very short period of time (often within a few minutes). Consequently, the aim of this study is to investigate whether the incorporation of Blood Flow Restriction (BFR) within a warm-up routine could be of additional value. Both performance parameters and muscle stiffness will be evaluated. As Hamstring strain Injuries (HSI) are common within sports encompassing high-speed running, this muscle group will be investigated on muscle stiffness as a representation of the interventional effect on muscle stiffness. Athletes will be randomized in two groups of 30 participants (anticipated); (1) an experimental group and (2) a control group. Both groups will perform baseline testing (5x Countermovement Jump, 25m Sprint and Muscle Strength of hamstrings and Quadriceps), and a short warm-up program, followed by repeating the same tests as executed in baseline. The experimental group will receive Blood Flow Restriction within the warm-up routine, whereas the control group will do the same warm up program but without BFR.
On a separate occasion, the same athletes will perform the same warm-up routine with a Shear Wave Elastographic assessment of the Biceps Femoris Long Head before and after (immediately after, after 5 minutes and once more after 10 minutes) the warm-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction | Experimental | Device: Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet)Incorporation of Blood Flow Restriction within the warm-up routine. |
| Control Group | Active comparator | Other: Warm-upWarm-up routine without any special intervention (no Blood Flow Restriction). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Free of pain at the moment of testing
- Adult (18+)
- Athletes (competitive team sport)
Key exclusion criteria (5 listed)
- History of a hamstring strain injury
- History of cardiovascular problems
- Recent (<1 year) trauma or surgery of the lower extremity
- Reduced functioning or pain in the lower extremity.
- Not being able to perform physical activities, for whatever (medical) reason.
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 |
|---|---|---|
| Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet)Also: Kaatsu, partial vascular occlusionBlood Flow Restriction | Device | Blood Flow Restriction |
| Warm-upWarm-up without any special intervention (no Blood Flow Restriction) | Other | Control Group |
Primary outcome
Change in muscle stiffness
Time frame: (1) Before the warm-up routine, (2) immediately after the warm-up routine, (3) 5 minutes after the warm-up routine, and (4) 10 minutes after the warm-up routine
The stiffness of the Biceps Femoris Long Head of the dominant leg will be assessed via a Shear Wave Elastography Device (Mach 30, SuperSonic Imagine), before and immediately after the warm-up routine. The muscle stiffness will be expressed in Kilopascals (kPa).
Change in jump height
Time frame: (1) Before the warm-up routine and (2) immediately after the warm-up routine
The jump height will be assessed during 5 consecutive countermovement jumps. This will be assessed with an OptoJump device. The highest jump will be taken into account. The jump height will be expressed in cm.
Change in muscle strength
Time frame: (1) Before the warm-up routine and (2) immediately after the warm-up routine
Muscle strength of the Hamstrings and Quadriceps muscles. Measured via a Hand Held Dynamometer. Strength will be expressed in Newton (N).
Change in sprinting speed
Time frame: (1) Before the warm-up routine and (2) immediately after the warm-up routine
Sprinting speed will be assessed at 5m, 10m and 25m. This via the use of timing gates. This outcome measure will be expressed in seconds (s).
2 secondary outcomes
level of readiness
Time frame: Immediately after the warm-up
Change in heart rate
Time frame: (1) Right before the warm up, (2) after one minute, (3) after two minutes, (4) after 3 minutes, (5) at the end of the warm up
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 5 Dec 2023.
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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.
Erik Witvrouw principal investigator
Departement of Rehabilitation Sciences, Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet) and Warm-up in people with Healthy, run by University Ghent at 1 site in Belgium.
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 3 inclusion and 5 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 5 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 Belgium. 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?
Change in muscle stiffness (time frame: (1) Before the warm-up routine, (2) immediately after the warm-up routine, (3) 5 minutes after the warm-up routine, and (4) 10 minutes after the warm-up routine). 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 5 Dec 2023.