Physical PerformanceMF2-TMG-CMJNCT05219344
Tissue Flossing and Lower Limb Neuromuscular Function
A study testing Tissue flossing in people with Physical Performance and Neuromuscular Function, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
There is no study investigating different volumes, that is various sets of the configuration of tissue flossing on neuromuscular function. Previously, investigators found that 3 sets of TF impaired neuromuscular function assessed with TMG. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Performance, Neuromuscular Function, Tissue Flossing
- What is being tested?
- Tissue flossing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 May 2021to 1 Dec 2021
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy and physically active male subjects
Who cannot join
- Subjects who have latex allergy, hypertension, venous thrombotic disease, cardio-respiratory disease, or neurological disorders, acute and or chronic neuromuscular injuries i.e., with a history of serious lower limb injuries in 12 months period prior to study began will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Volumes of Tissue Flossing Around Thigh Muscle on Neuromuscular Function
There is no study investigating different volumes, that is various sets of the configuration of tissue flossing on neuromuscular function. Previously, investigators found that 3 sets of TF impaired neuromuscular function assessed with TMG. Therefore, the aim is to compare the effects of one and two sets of TS on countermovement jump (CMJ) performance and muscle contractile properties.
Read the detailed description
The primary purpose of the study will be to examine the differences in one and two sets of applying tissue flossing to the thigh muscles on neuromuscular function using tensiomyography (TMG) and CMJ, while considering several measurement points after flossing application (i.e., +0.5min, +3min, +6min, +9min, +12min, +15min). A better understanding of the effects of flossing on acute performance enhancement as well as on individual muscle contractile properties could help practitioners to develop specific pre-conditioning activities and consequently improve athletic performance on the field. The investigators hypothesized that: (i) the application of tissue flossing will improve the contraction time of the vastus lateralis muscle as well as the maximal jumping performance, regardless of sets of configuration.
- Being tested
- Tissue flossing
- Keywords
- Physical Performance, Neuromuscular Function, CMJ, TMG, PAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue flossingProcedure or surgery
Also called ischemic preconditioning
After the standardized warm-up, participants will be instructed to stand still with their legs shoulder-width apart. The floss band (1.3 mm thick, 50 mm wide, 2 meters long, and strength level 3), consisting of a thick elastic latex band (COMPRE Floss, Sanctband), will be applied bilaterally around the distal third of the thigh. The applied pressure will be individualized by thigh circumferences, whereas low target pressure was chosen for this study, showing potential to elicit the most beneficial outcomes following flossing. The pressure will be monitored by the PicoPress device, which was placed at the middle distance of the application of the floss band to ensure that the entire surface of the pressure sensors was always completely covered. The flossing will be applied for 2 minutes with 2 minutes rest between sets. During flossing application subjects will be instructed to conduct 10 deep squats followed by 15 repetitions of knee extensions without added weight.
| Study group | Role | What they receive |
|---|---|---|
| One set of muscle flossing | Experimental | This group will receive one set of muscle flossing around the thigh with low pressure. Pressure will be individualized based on thigh circumferences. Receives: Procedure: Tissue flossing |
| Two sets of muscle flossing | Active comparator | This group will receive two sets of muscle flossing around the thigh with low pressure. Pressure will be individualized based on thigh circumferences. Receives: Procedure: Tissue flossing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tensiomyography
We will use TMG to assess PAP from pre to post-different tissue flossing procedures. The contractile properties of the individual muscles will be assessed by the non-invasive TMG method. We will measure the vastus lateralis muscle of the dominant leg only.
Measured: 20 seconds per single measurement
Countermovement jump
Countermovement and squat jumps will be used to assess muscle fatigue from pre to post-different Vo2max testing procedures. Jumping ability will be assessed by vertical jump tests, using a bilateral force plate (model 9260AA6, Kistler, Switzerland) with Kistler MARS software to record ground reaction force data.
Measured: 30 seconds per single measurement
Secondary outcomes (1)
Rate of perceived exertion
Rate of perceived exertion will be measured to assess subjective perception of the fatigue from pre-to post flossing procedure
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start20 May 2021
- Primary completion25 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical PerformanceStudies 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
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Paravlic, University of Ljubljana
- Investigators
- Armin Paravlic, PhD, Principal investigator, Faculty of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219344
- Sponsor's protocol ID
- Thigh Flossing 2022
- Acronym
- MF2-TMG-CMJ
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We can share our data upon a reasonable request to the principal investigator
Publications
Paravlic AH, Segula J, Drole K, Hadzic V, Pajek M, Vodicar J. Tissue Flossing Around the Thigh Does Not Provide Acute Enhancement of Neuromuscular Function. Front Physiol. 2022 Apr 27;13:870498. doi: 10.3389/fphys.2022.870498. eCollection 2022.
PubMed 35574482
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Volumes of Tissue Flossing Around Thigh Muscle on Neuromuscular Function
- ClinicalTrials.gov ID
- NCT05219344
- Acronym / sponsor ID
- MF2-TMG-CMJ / Thigh Flossing 2022
- Keywords
- Physical Performance, Neuromuscular Function, CMJ, TMG, PAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 2 Feb 2022 (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.
There is no study investigating different volumes, that is various sets of the configuration of tissue flossing on neuromuscular function. Previously, investigators found that 3 sets of TF impaired neuromuscular function assessed with TMG. Therefore, the aim is to compare the effects of one and two sets of TS on countermovement jump (CMJ) performance and muscle contractile properties.
Detailed description
The primary purpose of the study will be to examine the differences in one and two sets of applying tissue flossing to the thigh muscles on neuromuscular function using tensiomyography (TMG) and CMJ, while considering several measurement points after flossing application (i.e., +0.5min, +3min, +6min, +9min, +12min, +15min). A better understanding of the effects of flossing on acute performance enhancement as well as on individual muscle contractile properties could help practitioners to develop specific pre-conditioning activities and consequently improve athletic performance on the field. The investigators hypothesized that: (i) the application of tissue flossing will improve the contraction time of the vastus lateralis muscle as well as the maximal jumping performance, regardless of sets of configuration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| One set of muscle flossing | Experimental | Procedure: Tissue flossingThis group will receive one set of muscle flossing around the thigh with low pressure. Pressure will be individualized based on thigh circumferences. |
| Two sets of muscle flossing | Active comparator | Procedure: Tissue flossingThis group will receive two sets of muscle flossing around the thigh with low pressure. Pressure will be individualized based on thigh circumferences. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy and physically active male subjects
Key exclusion criteria (1 listed)
- Subjects who have latex allergy, hypertension, venous thrombotic disease, cardio-respiratory disease, or neurological disorders, acute and or chronic neuromuscular injuries i.e., with a history of serious lower limb injuries in 12 months period prior to study began will be excluded.
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 |
|---|---|---|
| Tissue flossingAlso: ischemic preconditioningAfter the standardized warm-up, participants will be instructed to stand still with their legs shoulder-width apart. The floss band (1.3 mm thick, 50 mm wide, 2 meters long, and strength level 3), consisting of a thick elastic latex band (COMPRE Floss, Sanctband), will be applied bilaterally around the distal third of the thigh. The applied pressure will be individualized by thigh circumferences, whereas low target pressure was chosen for this study, showing potential to elicit the most beneficial outcomes following flossing. The pressure will be monitored by the PicoPress device, which was placed at the middle distance of the application of the floss band to ensure that the entire surface of the pressure sensors was always completely covered. The flossing will be applied for 2 minutes with 2 minutes rest between sets. During flossing application subjects will be instructed to conduct 10 deep squats followed by 15 repetitions of knee extensions without added weight. | Procedure or surgery | One set of muscle flossing, Two sets of muscle flossing |
Primary outcome
Tensiomyography
Time frame: 20 seconds per single measurement
We will use TMG to assess PAP from pre to post-different tissue flossing procedures. The contractile properties of the individual muscles will be assessed by the non-invasive TMG method. We will measure the vastus lateralis muscle of the dominant leg only.
Countermovement jump
Time frame: 30 seconds per single measurement
Countermovement and squat jumps will be used to assess muscle fatigue from pre to post-different Vo2max testing procedures. Jumping ability will be assessed by vertical jump tests, using a bilateral force plate (model 9260AA6, Kistler, Switzerland) with Kistler MARS software to record ground reaction force data.
1 secondary outcome
Rate of perceived exertion
Time frame: 5 seconds
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 11 Jan 2024.
- Results publication: PubMed 35574482Paravlic AH, Segula J, Drole K, Hadzic V, Pajek M, Vodicar J. Tissue Flossing Around the Thigh Does Not Provide Acute Enhancement of Neuromuscular Function. Front Physiol. 2022 Apr 27;13:870498. doi: 10.3389/fphys.2022.870498. eCollection 2022.
- Publisher siteLink provided by the sponsor.
- Individual participant dataSharing planned: No. We can share our data upon a reasonable request to the principal investigator
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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.
Armin Paravlic, PhD principal investigator
Faculty of Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue flossing in people with Physical Performance and Neuromuscular Function, run by University of Ljubljana at 1 site in Slovenia.
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 1 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 11 Jan 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 Slovenia. 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?
Tensiomyography (time frame: 20 seconds per single measurement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219344, which also lists 1 linked publication.
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 11 Jan 2024.