Back to resultsEffect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
Primary Purpose
Health Behavior, Muscle Strain, Lower Leg
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
soft tissue flossing therapy
Sponsored by
About this trial
This is an interventional treatment trial for Health Behavior focused on measuring health behavior, hamstring flexibility, fascial shearing, delayed onset muscle soreness, muscle disorder, treatment, blood flow restriction training, myotonometer, muscle stiffness
Eligibility Criteria
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
Sites / Locations
- Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
soft tissue flossing therapy right lower limb
soft tissue flossing therapy left lower limb
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05684315
First Posted
January 3, 2023
Last Updated
June 5, 2023
Sponsor
Józef Piłsudski University of Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT05684315
Brief Title
Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
Official Title
Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Józef Piłsudski University of Physical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, muscle stiffness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
The subjects will not be informed what activity awaits them and which leg will be subjected to intervention.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
soft tissue flossing therapy right lower limb
Arm Type
Experimental
Arm Description
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.
Arm Title
soft tissue flossing therapy left lower limb
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
soft tissue flossing therapy
Other Intervention Name(s)
Blood Flow Restriction Training, BFRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Isokinetic muscle strength
Description
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.
Time Frame
40 days
Secondary Outcome Measure Information:
Title
Soft tissue assessment
Description
Changes in quadriceps femoris stiffness will be assessed by myometry performed separately for six points marked on the muscle before the test.
Time Frame
40 days
Title
Range of motion
Description
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.
Time Frame
40 days
Title
Visual Analogue Scale (1-100 mm)
Description
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.
Time Frame
40 days
Title
Pain assessment - Algometer
Description
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.
Time Frame
40 days
Title
Triple hop jump test
Description
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.
Time Frame
40 days
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szczepan Wiecha, Phd
Organizational Affiliation
Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
Official's Role
Study Director
Facility Information:
Facility Name
Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
City
Biała Podlaska
ZIP/Postal Code
21-500
Country
Poland
12. IPD Sharing Statement
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Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
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