Health BehaviorNCT05684315
Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
A study testing soft tissue flossing therapy in people with Health Behavior and Muscle Strain, Lower Leg, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Muscle Strain, Lower Leg
- What is being tested?
- soft tissue flossing therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePoland
- Study dates
- 9 Jan 2023to 17 Feb 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 20 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- men aged 20-25
- BMI (body mass index) at the level of 20-35
Who cannot join
- chronic diseases, musculoskeletal injuries, mental disorders, surgery or hospitalization
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
Biała Podlaska, 21-500
About this study
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.
- Conditions
- Health Behavior, Muscle Strain, Lower Leg
- Being tested
- soft tissue flossing therapy
- Keywords
- health behavior, hamstring flexibility, fascial shearing, delayed onset muscle soreness, muscle disorder, treatment, blood flow restriction training, myotonometer, muscle stiffness
- Medical subject headings
- Health Behavior, Sprains and Strains, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue flossing therapyProcedure or surgery
Also called Blood Flow Restriction Training, BFRT
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.
| Study group | Role | What they receive |
|---|---|---|
| soft tissue flossing therapy right lower limb | Experimental | 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. Receives: Procedure: soft tissue flossing therapy |
| soft tissue flossing therapy left lower limb | Experimental | 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. Receives: Procedure: soft tissue flossing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic muscle strength
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.
Measured: 40 days
Secondary outcomes (5)
Soft tissue assessment
Changes in quadriceps femoris stiffness will be assessed by myometry performed separately for six points marked on the muscle before the test.
Measured: 40 days
Range of motion
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.
Measured: 40 days
Visual Analogue Scale (1-100 mm)
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.
Measured: 40 days
Pain assessment - Algometer
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.
Measured: 40 days
Triple hop jump test
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.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start9 Jan 2023
- Primary completion13 Jan 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Crossover
- Model description
- The study will be conducted in two rounds over 4 weeks. In the first round, subjects will have one leg threaded during the fatigue protocol, and after a four-week rest after full recovery, they will have the other leg threaded during the fatigue protocol.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Szczepan Wiecha, Phd, Study director, Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684315
- Sponsor's protocol ID
- Academy of Physical Education
- Status last verified
- Feb 2023
- First submitted
- 3 Jan 2023
- Last updated
- 6 Jun 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 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
- ClinicalTrials.gov ID
- NCT05684315
- Acronym / sponsor ID
- Academy of Physical Education
- Conditions
- Health Behavior, Muscle Strain, Lower Leg
- Keywords
- health behavior, hamstring flexibility, fascial shearing, delayed onset muscle soreness, muscle disorder, treatment, blood flow restriction training, myotonometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 13 Jan 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will be conducted in two rounds over 4 weeks. In the first round, subjects will have one leg threaded during the fatigue protocol, and after a four-week rest after full recovery, they will have the other leg threaded during the fatigue protocol.
| Arm | Type | Receives |
|---|---|---|
| soft tissue flossing therapy right lower limb | Experimental | Procedure: soft tissue flossing therapyThe 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. |
| soft tissue flossing therapy left lower limb | Experimental | Procedure: soft tissue flossing therapyThe 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. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- men aged 20-25
- BMI (body mass index) at the level of 20-35
Key exclusion criteria (1 listed)
- chronic diseases, musculoskeletal injuries, mental disorders, surgery or hospitalization
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 |
|---|---|---|
| soft tissue flossing therapyAlso: Blood Flow Restriction Training, BFRTBFRT 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. | Procedure or surgery | soft tissue flossing therapy left lower limb, soft tissue flossing therapy right lower limb |
Primary outcome
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.
5 secondary outcomes
Soft tissue assessment
Time frame: 40 days
Range of motion
Time frame: 40 days
Visual Analogue Scale (1-100 mm)
Time frame: 40 days
Pain assessment - Algometer
Time frame: 40 days
Triple hop jump test
Time frame: 40 days
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 6 Jun 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.
Szczepan Wiecha, Phd study director
Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft tissue flossing therapy in people with Health Behavior and Muscle Strain, Lower Leg, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 2 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 6 Jun 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 Poland. 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?
Isokinetic muscle strength (time frame: 40 days). 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 6 Jun 2023.