- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684315
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- 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 Locations
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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:
|
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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)
January 9, 2023
Primary Completion (Actual)
January 13, 2023
Study Completion (Actual)
February 17, 2023
Study Registration Dates
First Submitted
January 3, 2023
First Submitted That Met QC Criteria
January 5, 2023
First Posted (Actual)
January 13, 2023
Study Record Updates
Last Update Posted (Actual)
June 6, 2023
Last Update Submitted That Met QC Criteria
June 5, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Health Behavior
-
Holbaek SygehusCompletedHealth Behavior | Health Knowledge, Attitudes, Practice | Health-Related Behavior | Health LiteracyDenmark
-
University of PennsylvaniaNot yet recruitingBehavior, HealthUnited States
-
University of PennsylvaniaNot yet recruiting
-
Yale UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedBehavior, HealthUnited States
-
Penn State UniversityCompletedBehavior, HealthUnited States
-
Henry Ford Health SystemUniversity of Kansas; University of Maryland, College ParkActive, not recruiting
-
Istinye UniversityRecruitingHealth-Related BehaviorTurkey (Türkiye)
-
University of Texas Rio Grande ValleyHealth and Human Services Commission (HHSC); Pharr-San Juan-Alamo Independent... and other collaboratorsCompletedHealth-Related BehaviorUnited States
-
University of PrimorskaUniversity of Ljubljana, Faculty of Social Sciences; Ministry of Defence, SloveniaActive, not recruitingHealth-Related BehaviorSlovenia
-
University of LisbonRecruitingOral Health Behavior Change | Oral Health Care | Oral Health Self-efficacyPortugal
Clinical Trials on soft tissue flossing therapy
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedEffects of Tissue Flossing on Pain and Functional Performance in Patients With Achilles TendinopathyAchilles Tendinopathy (AT)Pakistan
-
University Fernando PessoaCompleted
-
University School of Physical Education in WroclawAalborg University; Universidad Rey Juan CarlosCompleted
-
Université de SherbrookeCanadian Interdisciplinary Network Complementary & Alternative Medicine Research and other collaboratorsCompletedCesarean Section ComplicationsCanada
-
University of LjubljanaCompletedPhysical Performance | Ischemic Preconditioning | Neuromuscular Function | Tissue FlossingSlovenia
-
Charles University, Czech RepublicCompletedTissue FlossingCzechia
-
University of ChileCompleted
-
Riphah International UniversityCompleted