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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05684315
Other study ID # Academy of Physical Education
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date February 17, 2023

Study information

Verified date February 2023
Source Józef Pilsudski University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 17, 2023
Est. primary completion date January 13, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Poland Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska Biala Podlaska

Sponsors (1)

Lead Sponsor Collaborator
Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 40 days
Secondary 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. 40 days
Secondary 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. 40 days
Secondary 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. 40 days
Secondary 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. 40 days
Secondary 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. 40 days
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