NCT05684315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
Last Updated

June 6, 2023

Status Verified

February 1, 2023

Enrollment Period

4 days

First QC Date

January 3, 2023

Last Update Submit

June 5, 2023

Conditions

Health BehaviorMuscle Strain, Lower Leg

Keywords

health behaviorhamstring flexibilityfascial shearingdelayed onset muscle sorenessmuscle disordertreatmentblood flow restriction trainingmyotonometermuscle stiffness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Soft tissue assessment

    40 days

  • Range of motion

    40 days

  • Visual Analogue Scale (1-100 mm)

    40 days

  • Pain assessment - Algometer

    40 days

  • Triple hop jump test

    40 days

Study Arms (2)

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.

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.

Procedure: soft tissue flossing therapy

Interventions

soft tissue flossing therapyPROCEDURE

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.

Also known as: Blood Flow Restriction Training, BFRT
soft tissue flossing therapy left lower limbsoft tissue flossing therapy right lower limb

Eligibility Criteria

Age20 Years - 25 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska

Biała Podlaska, 21-500, Poland

Location

MeSH Terms

Conditions

Health BehaviorSprains and StrainsMuscular Diseases

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

BehaviorWounds and InjuriesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Szczepan Wiecha, Phd

    Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The subjects will not be informed what activity awaits them and which leg will be subjected to intervention.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 13, 2023

Study Start

January 9, 2023

Primary Completion

January 13, 2023

Study Completion

February 17, 2023

Last Updated

June 6, 2023

Record last verified: 2023-02

Locations

PL(1)