Tissue Flossing and Lower Limb Neuromuscular Function (MF2-TMG-CMJ)

January 9, 2024 updated by: Armin Paravlic, University of Ljubljana

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Faculty of Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy and physically active male subjects

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One set of muscle flossing
This group will receive one set of muscle flossing around the thigh with low pressure. Pressure will be individualized based on thigh circumferences.
Procedure: Tissue flossing
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.
Other Names:
  • ischemic preconditioning
Active Comparator: Two sets of muscle flossing
This group will receive two sets of muscle flossing around the thigh with low pressure. Pressure will be individualized based on thigh circumferences.
Procedure: Tissue flossing
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.
Other Names:
  • ischemic preconditioning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
20 seconds per single measurement
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.
30 seconds per single measurement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of perceived exertion
Time Frame: 5 seconds
Rate of perceived exertion will be measured to assess subjective perception of the fatigue from pre-to post flossing procedure
5 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ljubljana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Armin Paravlic, PhD, Faculty of Sport

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Thigh Flossing 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We can share our data upon a reasonable request to the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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