Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness

June 5, 2023 updated by: Józef Piłsudski University of Physical Education
The aim of the study is to assess whether soft tissue flossing therapy will alleviate eccentric muscle-destroying influences. Men aged 20-25 will be tested. Suddenly taking up activity in untrained people and performing the fatigue protocol is a heavy burden for the body, and its effects may have a negative impact on the body. The assessment of the processes taking place in the body under the influence of this type of physical activity with the use of soft tissue flossing will broaden the scope of knowledge about this therapeutic method and will allow assessing whether it has an impact on accelerating regeneration after intense physical exertion.

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

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.
18

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

  • Poland
      • Biała Podlaska, Poland, 21-500
        • Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska

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

20 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • men aged 20-25
  • BMI (body mass index) at the level of 20-35

Exclusion Criteria:

• chronic diseases, musculoskeletal injuries, mental disorders, surgery or hospitalization

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: Crossover Assignment
  • Masking: Double

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: soft tissue flossing therapy right lower limb
The study will be conducted in two rounds, 4 weeks apart. In round one, subjects will have their right leg flossed while performing the fatigue protocol.
Procedure: soft tissue flossing therapy
BFRT and tissue threading is a therapy that involves applying external pressure below or above a joint or muscle of a selected limb, usually with a circumferential elastic band. The pressure provided by the rolled band securely maintains arterial blood supply but reduces or blocks venous outflow distal to the site.
Other Names:
  • Blood Flow Restriction Training
  • BFRT
Experimental: soft tissue flossing therapy left lower limb
The study will be conducted in two rounds, 4 weeks apart. In round one, subjects will have their left leg flossed while performing the fatigue protocol.
Procedure: soft tissue flossing therapy
BFRT and tissue threading is a therapy that involves applying external pressure below or above a joint or muscle of a selected limb, usually with a circumferential elastic band. The pressure provided by the rolled band securely maintains arterial blood supply but reduces or blocks venous outflow distal to the site.
Other Names:
  • Blood Flow Restriction Training
  • BFRT

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
Isokinetic muscle strength
Time Frame: 40 days
Measurements will be performed on an isokinetic dynamometer (Biodex Medical System 4-PRO, New York, USA). According to the manufacturer's protocol, the dynamometer will be calibrated before each test session. The gravity correction will be performed before each series of measurements. Before the intervention, participants will perform a 5-minute warm-up on the bicycle ergometer with a power of 120 W.
40 days

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
Soft tissue assessment
Time Frame: 40 days
Changes in quadriceps femoris stiffness will be assessed by myometry performed separately for six points marked on the muscle before the test.
40 days
Range of motion
Time Frame: 40 days
Knee Range of motion will be measured with a 360° 14- inch hand held metal goniometer (Fabrication Enterprises, USA). During the measurement, the tested person will be in the supine position. A stabilizing belt will be placed at the height of the sacrum. The axis of rotation of the goniometer will be set at the height of the space of the knee joint. One arm of the goniometer will be aimed at the greater trochanter and the other arm at the lateral malleolus of the fibula. Landmarks for subsequent measurements will be marked on the first day on the subjects' bodies with a semi-permanent marker. Participants will be asked to perform maximum full knee flexion. The knee angle measurement will be repeated three times, and the average result will be included in further analysis.
40 days
Visual Analogue Scale (1-100 mm)
Time Frame: 40 days
A Visual Analogue Scale will be was used to assess pain - the subjects will mark the level of pain perception on a colour scale (1-100 mm) immediately after all exercise tests where a value of 1 is attributed to no pain at all, and a value of 100 is the worst pain imaginable.
40 days
Pain assessment - Algometer
Time Frame: 40 days
Measurement of the pain threshold under the influence of pressure on the muscle will be tested with a digital algometer "Digital Force Algometer" at six points marked on the muscle before the tests.
40 days
Triple hop jump test
Time Frame: 40 days
In the triple jump test, subjects will perform the longest possible jump on one leg three times in a row. During the test, they must not lose their balance and must land safely. The distance will be measured from the starting line to the supporting heel.
40 days

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.
Józef Piłsudski University of Physical Education

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.
  • Study Director: Szczepan Wiecha, Phd, Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska

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.
January 9, 2023

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.
January 13, 2023

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.
February 17, 2023

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 3, 2023

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 5, 2023

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.
January 13, 2023

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.
June 6, 2023

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.
June 5, 2023

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.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • Academy of Physical Education

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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