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Reliability and Performance Analysis of the Use of Tissue Flossing for Blood Flow Restriction.

Primary Purpose

Hypertrophy, Muscle Strength

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tissue Flossing
Blood Flow Restriction Cuff
Training Protocol
Sponsored by
Paulista University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertrophy focused on measuring tissue flossing, blood flow restriction

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals who present one or more of the following characteristics will not be included: 1 presence of any health condition that contraindicates or prevents exercise; 2 diabetes and diagnosed high blood pressure; 3 inflammatory, psychiatric, cardiovascular and/or respiratory rheumatological disease; - -4 being dependent on alcohol, consuming drugs and/or being a smoker; 5 history of knee surgery (e.g., meniscal repair and ligament reconstruction) or recent lower limb musculoskeletal injury that may impair performance during tests or interventions (e.g., muscle injury, tendinopathy, patellofemoral pain and/or back pain column in the last six months); 6 use of ergogenic supplements to improve physical performance and/or muscle mass and/or vasoactive medications; 7 having one or more risk factors predisposing to thromboembolism Exclusion Criteria: Participants will be excluded from the study if they: 1 have a health problem that does not allow them to continue; 2 wish to leave the study; 3 not sign the consent form

Sites / Locations

  • Franciele Marques Vanderlei

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Blood Flow Restriction with Cuffing

Blood Flow Restriction with Tissue Flossing

Arm Description

The participant will use the Cuffing for Blood Flow Restriction training

The participant will use Tissue Flossing for Blood Flow Restriction training

Outcomes

Primary Outcome Measures

Occlusion pressures (AOP, 80% and 40% of AOP)
To determine the AOP, the Doppler equipment transducer will be used, which will be positioned over the posterior tibial artery to capture the auscultatory pulse. A blood pressure cuff will be fixed to the participant's thigh close to the region of the inguinal fold of the dominant limb, and then with the inflatable region of the cuff on the medial portion of the thigh covering the femoral artery, it will be progressively inflated, waiting 15 seconds every 30 mmHg until the point at which the auscultatory pulse of the tibial artery is interrupted.
Assessment of arterial flow and diameter
A Sonoline Sienna® vascular ultrasound will be used combined with a 40mm B-mode ultrasonic transducer with a 7.5 MHz linear beam, which will be coated with gel for acoustic contact and positioned longitudinally to the posterior tibial artery, enabling variables to be assessed. Doppler flow measurements of MI (peak systolic velocity [cm/s], end-diastolic velocity [cm/s] and arterial diameter).
Perceptual parameter
The perceptual parameter will be evaluated using a Borg CR10+ scale, representing the perception of discomfort, 0 represents no discomfort and 10 extremely uncomfortable.
Tissue Flossing Assessment
The application of tissue flossing on the leg will be carried out by always passing the elastic tape with 50% of the tape over the next strip, until the end of the elastic tape.
Weight
It will be collected with a weight balance
Height
It will be collected with a stadiometer
Body Fat
It will be collected with a adipometer
Arterial pressure
It will be collected with a sphygmomanometer
Perimetry of the dominant lower limb
It will be defined by the Waterloo Footedness
Limb length
Identified with a measuring tape
Perceived exertion scale
Adapted BORG scale, with 0 being "no effort" and 10 "maximum effort".
Method preference
Participants must answer a brief questionnaire about their preference for one of the RFS methods carried out, and justify why they chose it.
1 Maximum Repetition Test
The participant must be positioned seated on the extension chair with knees and feet hip-width apart, knees at 90° flexion determined by goniometry, hands holding the handles adjacent to the hips and lumbosacral spine in a firm position in contact with the back of the chair. 1 repetition should be performed to familiarize the movement and 10 repetitions to warm up. At the beginning of the test, they will be instructed to maintain a movement pattern and avoid compensation. The RM is then defined by the highest load at which the participant is capable of performing 1 repetition without compensation.
Myotonometry
Myotonometry will be assessed using the MyotonPRO® tool, which consists of a portable, wireless and non-invasive device. The measurement will be carried out once, and in each shot, the following myotonometry parameters will be calculated: the state of tension (tone) and biomechanical properties (rigidity and elasticity).
Ultrasound
The assessment of the muscular structure will be carried out using ultrasound images of the participant's lower limbs, which will be captured using BodyMetrix BX-2000. Participants will be assessed in the supine position with legs fully extended and muscles relaxed. The ultrasound transducer will be covered with water-soluble transmission gel and positioned perpendicular to the skin over the muscle.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2023
Last Updated
October 4, 2023
Sponsor
Paulista University
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1. Study Identification

Unique Protocol Identification Number
NCT06075901
Brief Title
Reliability and Performance Analysis of the Use of Tissue Flossing for Blood Flow Restriction.
Official Title
Reliability, Reproducibility and Performance Analysis of the Use of Tissue Flossing for Blood Flow Restriction.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paulista University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Blood flow restriction (RFS) is a widely studied technique that combines low-intensity exercise with vascular occlusion, resulting in muscular benefits. However, its application is challenging due to methodological variations and equipment costs. Tissue Flossing (TF) appears as an affordable alternative, but lacks solid scientific evidence.
Detailed Description
Objectives: to evaluate the intra- and inter-rater reliability of the occlusion pressure generated by TF, investigate the reproducibility of TF application on different days and compare TF with traditional RFS in terms of muscle gains. Methods: the study is divided into two stages: First stage, randomized controlled crossover clinical trial, 80 healthy individuals aged 18 to 30 years old evaluated to determine the reliability of the TF. Participants will follow one of two types of randomization, with exclusions based on health criteria. Assessments include anthropometric characteristics, determination of occlusion pressure (POT), identification of 40% and 80% of POT, flow data and arterial diameter after TF application. Statistical analysis will use the intraclass correlation index (ICC) and specific models for intra- and inter-rater analyses. Second stage, randomized controlled clinical trial with parallel groups, 110 recreational athletes will be evaluated over four weeks. The initial procedures involve anthropometric assessments, POT determination, myotonometry, ultrasound, perceptual scale and 1RM test, applied to both lower limbs. Participants will perform a lower limb training protocol, using RFS and TF on different legs, following myotonometric and perceptual assessments. After training, final assessments will measure the same parameters initially assessed. Statistical analysis will use normality tests, Generalized Mixed Models and effect size analysis in SPSS software, with a significance level of p<0.05. Expected results: This study is expected to provide information on the reliability and reproducibility of TF in generating occlusion pressure. Furthermore, we seek to validate TF by comparing it with traditional RFS in terms of muscle gains. If effective, TF could become an affordable option to promote muscle gains, in different application scenarios. Participants will be duly informed about the procedures and objectives of this study, and after agreeing, they will sign an informed consent form, effectively becoming part of it. In the consent form, participants will be asked if they agree to the use of their data if they choose to withdraw from the study. Participants will also be asked for permission for the research team to share relevant data with people at universities participating in the research or regulatory authorities, where relevant. The study will be sent for consideration and approval to the Research Ethics Committee of FCT/UNESP, Presidente Prudente, SP, Brazil.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy, Muscle Strength
Keywords
tissue flossing, blood flow restriction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Restriction with Cuffing
Arm Type
Active Comparator
Arm Description
The participant will use the Cuffing for Blood Flow Restriction training
Arm Title
Blood Flow Restriction with Tissue Flossing
Arm Type
Experimental
Arm Description
The participant will use Tissue Flossing for Blood Flow Restriction training
Intervention Type
Device
Intervention Name(s)
Tissue Flossing
Intervention Description
Tissue Flossing ia a elastic band that when applied exerts an external pressure above or below a muscle or joint of the extremities.
Intervention Type
Device
Intervention Name(s)
Blood Flow Restriction Cuff
Intervention Description
Inflatable device that exerts an external pressure above a muscle or joint of the extremities.
Intervention Type
Other
Intervention Name(s)
Training Protocol
Intervention Description
The lower limb resistance training protocol will follow that recommended in the study by Patterson et al. for resistance training, and will last 4 weeks, with 3 training sessions per week, with a day break between sessions.
Primary Outcome Measure Information:
Title
Occlusion pressures (AOP, 80% and 40% of AOP)
Description
To determine the AOP, the Doppler equipment transducer will be used, which will be positioned over the posterior tibial artery to capture the auscultatory pulse. A blood pressure cuff will be fixed to the participant's thigh close to the region of the inguinal fold of the dominant limb, and then with the inflatable region of the cuff on the medial portion of the thigh covering the femoral artery, it will be progressively inflated, waiting 15 seconds every 30 mmHg until the point at which the auscultatory pulse of the tibial artery is interrupted.
Time Frame
First and Secund Stage - [Time Frame: baseline]
Title
Assessment of arterial flow and diameter
Description
A Sonoline Sienna® vascular ultrasound will be used combined with a 40mm B-mode ultrasonic transducer with a 7.5 MHz linear beam, which will be coated with gel for acoustic contact and positioned longitudinally to the posterior tibial artery, enabling variables to be assessed. Doppler flow measurements of MI (peak systolic velocity [cm/s], end-diastolic velocity [cm/s] and arterial diameter).
Time Frame
First Stage - [Time Frame: baseline and all subsequent assessments]
Title
Perceptual parameter
Description
The perceptual parameter will be evaluated using a Borg CR10+ scale, representing the perception of discomfort, 0 represents no discomfort and 10 extremely uncomfortable.
Time Frame
First and Secund Stage - [Time Frame: baseline and all subsequent assessments]
Title
Tissue Flossing Assessment
Description
The application of tissue flossing on the leg will be carried out by always passing the elastic tape with 50% of the tape over the next strip, until the end of the elastic tape.
Time Frame
First Stage - [Time Frame: The subsequent assessments]
Title
Weight
Description
It will be collected with a weight balance
Time Frame
First and Secund Stage- [Time Frame: Baseline ]
Title
Height
Description
It will be collected with a stadiometer
Time Frame
First and Secund Stage- [Time Frame: Baseline ]
Title
Body Fat
Description
It will be collected with a adipometer
Time Frame
First and Secund Stage- [Time Frame: Baseline ]
Title
Arterial pressure
Description
It will be collected with a sphygmomanometer
Time Frame
First and Secund Stage- [Time Frame: Baseline ]
Title
Perimetry of the dominant lower limb
Description
It will be defined by the Waterloo Footedness
Time Frame
First and Secund Stage- [Time Frame: Baseline ]
Title
Limb length
Description
Identified with a measuring tape
Time Frame
First and Secund Stage- [Time Frame: Baseline ]
Title
Perceived exertion scale
Description
Adapted BORG scale, with 0 being "no effort" and 10 "maximum effort".
Time Frame
Secund Stage- [Time Frame: at the end of the training sessions]
Title
Method preference
Description
Participants must answer a brief questionnaire about their preference for one of the RFS methods carried out, and justify why they chose it.
Time Frame
Secund Stage- [Time Frame: final evaluation]
Title
1 Maximum Repetition Test
Description
The participant must be positioned seated on the extension chair with knees and feet hip-width apart, knees at 90° flexion determined by goniometry, hands holding the handles adjacent to the hips and lumbosacral spine in a firm position in contact with the back of the chair. 1 repetition should be performed to familiarize the movement and 10 repetitions to warm up. At the beginning of the test, they will be instructed to maintain a movement pattern and avoid compensation. The RM is then defined by the highest load at which the participant is capable of performing 1 repetition without compensation.
Time Frame
Secund Stage- [Time Frame: baseline and final evaluation]
Title
Myotonometry
Description
Myotonometry will be assessed using the MyotonPRO® tool, which consists of a portable, wireless and non-invasive device. The measurement will be carried out once, and in each shot, the following myotonometry parameters will be calculated: the state of tension (tone) and biomechanical properties (rigidity and elasticity).
Time Frame
Secund Stage- [Time Frame: baseline during follow-up and final evaluation]
Title
Ultrasound
Description
The assessment of the muscular structure will be carried out using ultrasound images of the participant's lower limbs, which will be captured using BodyMetrix BX-2000. Participants will be assessed in the supine position with legs fully extended and muscles relaxed. The ultrasound transducer will be covered with water-soluble transmission gel and positioned perpendicular to the skin over the muscle.
Time Frame
Secund Stage- [Time Frame: baseline and final evaluation]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals who present one or more of the following characteristics will not be included: 1 presence of any health condition that contraindicates or prevents exercise; 2 diabetes and diagnosed high blood pressure; 3 inflammatory, psychiatric, cardiovascular and/or respiratory rheumatological disease; - -4 being dependent on alcohol, consuming drugs and/or being a smoker; 5 history of knee surgery (e.g., meniscal repair and ligament reconstruction) or recent lower limb musculoskeletal injury that may impair performance during tests or interventions (e.g., muscle injury, tendinopathy, patellofemoral pain and/or back pain column in the last six months); 6 use of ergogenic supplements to improve physical performance and/or muscle mass and/or vasoactive medications; 7 having one or more risk factors predisposing to thromboembolism Exclusion Criteria: Participants will be excluded from the study if they: 1 have a health problem that does not allow them to continue; 2 wish to leave the study; 3 not sign the consent form
Facility Information:
Facility Name
Franciele Marques Vanderlei
City
Presidente Prudente
State/Province
SP
ZIP/Postal Code
55
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Reliability and Performance Analysis of the Use of Tissue Flossing for Blood Flow Restriction.

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