Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06075901
Study type Interventional
Source Paulista University
Contact
Status Not yet recruiting
Phase N/A
Start date May 1, 2024
Completion date July 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Completed NCT04136821 - The Long-term Effects of Oceanix™ on Resistance Training Adaptations N/A
Recruiting NCT05945641 - Effect of Low-load Resistance Training vs. High-intensity Interval Training on Local Muscle Endurance N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A
Completed NCT03715920 - Comparison of Different Quadriceps Femoris Isometric Strengthening Methods N/A
Terminated NCT01561404 - Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise Phase 4
Completed NCT04535336 - Vitality Acupunch Exercise Program for Older Adults With Sarcopenia N/A
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Recruiting NCT06061315 - Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men N/A
Completed NCT05366348 - The Effects of Horse-back Riding on Core Muscles in Adolescents N/A
Completed NCT04213586 - Effects of Whey Protein and Collagen Supplementation N/A
Completed NCT04626817 - Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study N/A
Completed NCT03922113 - Muscle Function After Intensive Care
Completed NCT01449097 - Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers Phase 4
Completed NCT05882981 - Increased Femoral Anteversion and Physical Performance
Completed NCT06196268 - Core Strengthening vs Pilates Exercises on Posture, Body Awareness and Fatigue Among Female Athletes N/A
Completed NCT00059436 - Mental Effort and Muscle Strength Phase 1
Recruiting NCT06410014 - Assessment of Overall Functioning in Patients With Complex Health Issues
Completed NCT04239417 - Effect of Preoperative Abdominal Exercises and Russian Current on Muscle Strength Post Ventral Hernioplasty N/A
Completed NCT04315077 - The Short Term Effects of Oceanix Supplementation on Recovery N/A