NCT05219344

Brief 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. Therefore, the aim is to compare the effects of one and two sets of TS on countermovement jump (CMJ) performance and muscle contractile properties.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 20, 2022

Last Update Submit

January 9, 2024

Conditions

Keywords

Physical Performance, Neuromuscular Function, CMJ, TMG, PAP

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    30 seconds per single measurement

Secondary Outcomes (1)

  • Rate of perceived exertion

    5 seconds

Study Arms (2)

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.

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.

Procedure: Tissue flossing

Interventions

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.

Also known as: ischemic preconditioning
One set of muscle flossingTwo sets of muscle flossing

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male subjects will be recruited
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy and physically active male subjects

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Interventions

Ischemic Preconditioning

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Armin Paravlic, PhD

    Faculty of Sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The kinesiologist (care provider), investigator and assessors will be blind for group allocation of the participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Sport

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 2, 2022

Study Start

May 20, 2021

Primary Completion

October 25, 2021

Study Completion

December 1, 2021

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

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

Locations