Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT06512961
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-31
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Reliability and Performance Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006984', 'term': 'Hypertrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occlusion pressures (AOP, 80% and 40% of AOP)', 'timeFrame': '3 days', 'description': "To determine the AOP, the Doppler equipment transducer will be used, which will be positioned over the brachii 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 brachii artery is interrupted."}, {'measure': 'Assessment of arterial flow and diameter', 'timeFrame': '3 days', '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 brachii artery, enabling variables to be assessed. Doppler flow measurements of upper limb (peak systolic velocity \\[cm/s\\], end-diastolic velocity \\[cm/s\\] and arterial diameter).'}, {'measure': 'Perceptual parameter', 'timeFrame': '3 days', '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.'}, {'measure': 'Tissue Flossing Assessment', 'timeFrame': '3 days', '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.'}, {'measure': 'Weight', 'timeFrame': '3 days', 'description': 'It will be collected with a weight balance'}, {'measure': 'Height', 'timeFrame': '1 day', 'description': 'It will be collected with a stadiometer'}, {'measure': 'Body Fat', 'timeFrame': '1 day', 'description': 'It will be collected with a adipometer'}, {'measure': 'Arterial pressure', 'timeFrame': '1 day', 'description': 'It will be collected with a sphygmomanometer'}, {'measure': 'Perimetry of the dominant upper limb', 'timeFrame': '1 day', 'description': 'It will be defined by the Waterloo Footedness'}, {'measure': 'Limb length', 'timeFrame': '1 day', 'description': 'Identified with a measuring tape'}, {'measure': 'Perceived exertion scale', 'timeFrame': 'up to 15 weeks', 'description': 'Adapted BORG scale, with 0 being "no effort" and 10 "maximum effort".'}, {'measure': 'Method preference', 'timeFrame': 'up to 15 weeks', 'description': 'Participants must answer a brief questionnaire about their preference for one of the BFR methods carried out, and justify why they chose it.'}, {'measure': '1 Maximum Repetition Test', 'timeFrame': 'up to 15 weeks', 'description': "The warm-up will include a series of 6 to 10 repetitions, using approximately 50% of the estimated load for the first attempt of the test (44). This warm-up will not only prepare participants but also familiarize them with the movement. The determination of the initial warm-up load will be made subjectively by the researcher responsible for the study, considering the participant's height, body mass and training experience as reference points (45).\n\nAfter the warm-up phase, up to five attempts will be given to find the 1RM, with intervals of 3 to 5 minutes between them (46). The load adjustment for subsequent attempts will be determined by the subjective perception of effort, according to the BORG scale, where the greater the perception of effort, the lower the percentage of load added for the next attempt. The 1RM will be established as the maximum load at which the participant can perform one repetition without compensation."}, {'measure': 'Myotonometry', 'timeFrame': 'up to 15 weeks', 'description': 'Myotonometry will be assessed using the MyotonPRO® tool, which consists of a portable, wireless and non-invasive device.\n\nThe 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).'}, {'measure': 'Ultrasound', 'timeFrame': 'up to 15 weeks', 'description': "The assessment of the muscular structure will be carried out using ultrasound images of the participant's upper limbs, which will be captured using BodyMetrix BX-2000.\n\nParticipants will be assessed in the supine position with arms 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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tissue flossing', 'Blood flow restriction'], 'conditions': ['Hypertrophy', 'Muscle Strength']}, 'descriptionModule': {'briefSummary': 'Blood flow restriction (BFR) 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.', 'detailedDescription': '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.\n\nMethods: 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, 34 participants will be evaluated over fifteen weeks. The initial procedures involve anthropometric assessments, POT determination, myotonometry, ultrasound, perceptual scale and 1RM test, applied to both upper limbs. Participants will perform a upper limb training protocol using RFS or TF, 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, the investigatorsF 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.\n\nParticipants 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 were approved to the Research Ethics Committee of FCT/UNESP, Presidente Prudente, SP, Brazil.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who present one or more of the following characteristics will not be included:\n* 1 presence of any health condition that contraindicates or prevents exercise;\n* 2 diabetes and diagnosed high blood pressure;\n* 3 inflammatory, psychiatric, cardiovascular and/or respiratory rheumatological disease; - -4 being dependent on alcohol, consuming drugs and/or being a smoker;\n* 5 history of knee surgery (e.g., meniscal repair and ligament reconstruction) or recent upper 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);\n* 6 use of ergogenic supplements to improve physical performance and/or muscle mass and/or vasoactive medications;\n* 7 having one or more risk factors predisposing to thromboembolism\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if they:\n* 1 have a health problem that does not allow them to continue;\n* 2 wish to leave the study;\n* 3 not sign the consent form'}, 'identificationModule': {'nctId': 'NCT06512961', 'briefTitle': 'Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Reliability and Performance Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Paulista University'}, 'officialTitle': 'Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Study of Reliability, Reproducibility and Performance Analysis', 'orgStudyIdInfo': {'id': '78229724.9.0000.5402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Traditional BFR', 'description': 'This group will perform the training protocol with traditional BFR, using a pressure cuff as an occluder on both arms.', 'interventionNames': ['Device: Blood Flow Restriction Cuff', 'Other: Training Protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Group BFR TF', 'description': 'This group will perform the training protocol with BFR using TF on both arms.', 'interventionNames': ['Device: Tissue Flossing', 'Other: Training Protocol']}], 'interventions': [{'name': 'Tissue Flossing', 'type': 'DEVICE', 'description': 'Tissue Flossing ia a elastic band that when applied exerts an external pressure above or below a muscle or joint of the extremities.', 'armGroupLabels': ['Group BFR TF']}, {'name': 'Blood Flow Restriction Cuff', 'type': 'DEVICE', 'description': 'Inflatable device that exerts an external pressure above a muscle or joint of the extremities.', 'armGroupLabels': ['Group Traditional BFR']}, {'name': 'Training Protocol', 'type': 'OTHER', 'description': 'The upper limb resistance training protocol will follow that recommended in the study by Patterson et al. for resistance training, and will last 15weeks, with 3 training sessions per week, with a day break between sessions.', 'armGroupLabels': ['Group BFR TF', 'Group Traditional BFR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19060900', 'city': 'Presidente Prudente', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'UNESP', 'geoPoint': {'lat': -22.12556, 'lon': -51.38889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paulista University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordination for the Improvement of Higher Education Personnel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Franciele Marques Vanderle', 'investigatorAffiliation': 'Paulista University'}}}}