Muscle Strength Clinical Trial
Official title:
Reliability, Reproducibility and Performance Analysis of the Use of Tissue Flossing for Blood Flow Restriction.
Verified date | March 2024 |
Source | Paulista University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 136 |
Est. completion date | July 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Franciele Marques Vanderlei | Presidente Prudente | SP |
Lead Sponsor | Collaborator |
---|---|
Paulista University |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | First and Secund Stage - [Time Frame: baseline] | |
Primary | 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). | First Stage - [Time Frame: baseline and all subsequent assessments] | |
Primary | 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. | First and Secund Stage - [Time Frame: baseline and all subsequent assessments] | |
Primary | 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. | First Stage - [Time Frame: The subsequent assessments] | |
Primary | Weight | It will be collected with a weight balance | First and Secund Stage- [Time Frame: Baseline ] | |
Primary | Height | It will be collected with a stadiometer | First and Secund Stage- [Time Frame: Baseline ] | |
Primary | Body Fat | It will be collected with a adipometer | First and Secund Stage- [Time Frame: Baseline ] | |
Primary | Arterial pressure | It will be collected with a sphygmomanometer | First and Secund Stage- [Time Frame: Baseline ] | |
Primary | Perimetry of the dominant lower limb | It will be defined by the Waterloo Footedness | First and Secund Stage- [Time Frame: Baseline ] | |
Primary | Limb length | Identified with a measuring tape | First and Secund Stage- [Time Frame: Baseline ] | |
Primary | Perceived exertion scale | Adapted BORG scale, with 0 being "no effort" and 10 "maximum effort". | Secund Stage- [Time Frame: at the end of the training sessions] | |
Primary | 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. | Secund Stage- [Time Frame: final evaluation] | |
Primary | 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. |
Secund Stage- [Time Frame: baseline and final evaluation] | |
Primary | 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). |
Secund Stage- [Time Frame: baseline during follow-up and final evaluation] | |
Primary | 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. |
Secund Stage- [Time Frame: baseline and final evaluation] |
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