[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568244":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":43,"interventions":66,"overallOfficials":32,"centralContacts":32,"locations":84,"responsibleParty":105,"collaborators":109,"id":113,"slug":32,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":32,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":32,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":87,"whyStopped":32,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Universidade Federal de Sao Carlos","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Diastolic Blood Pressure","Diastolic blood pressure measured in millimeters of mercury (mmHg)","Acute effect (immediately post-intervention until 24 hours after)",[14,17,20,24,28],{"measure":15,"description":16,"timeFrame":12},"Systolic Blood Pressure","systolic blood pressure measured in millimeters of mercury (mmHg)",{"measure":18,"description":19,"timeFrame":12},"Mean Arterial Pressure","mean arterial pressure measured in millimeters of mercury (mmHg)",{"measure":21,"description":22,"timeFrame":23},"Endothelial Function","Endothelial function measured by flow-mediated dilation, with a brachial artery ultrasound","Acute effect (About 25 minutes post-intervention)",{"measure":25,"description":26,"timeFrame":27},"Arterial Stiffness","Arterial stiffness measured by pulse wave velocity","Acute effect (About 15 minutes post-intervention)",{"measure":29,"description":30,"timeFrame":31},"Blood Nitrite","Blood nitrite levels","Acute effect (1 hour post-intervention)",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","FACTORIAL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":39},"TRIPLE",[40,41,42],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[44,50,56,61],{"label":45,"type":46,"description":47,"interventionNames":48},"Panel Group","EXPERIMENTAL","Participants who will receive full-body photobiomodulation irradiation, from a panel of LEDs",[49],"Device: Panel Effective Photobiomodulation Therapy",{"label":51,"type":52,"description":53,"interventionNames":54},"Panel Sham Group","SHAM_COMPARATOR","Participants who will receive full-body photobiomodulation irradiation, with the device turned-off",[55],"Device: Sham Panel Photobiomodulation Therapy",{"label":57,"type":46,"description":58,"interventionNames":59},"Modified ILIB Group","Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method",[60],"Device: Modified ILIB Photobiomodulation Therapy",{"label":62,"type":52,"description":63,"interventionNames":64},"Modified ILIB Sham Group","Participants who will received photobiomodulation irradiation with the transcutaneous ILIB method, with the device turned-off",[65],"Device: Modified ILIB Sham Photobiomodulation Therapy",[67,72,76,80],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":32},"DEVICE","Panel Effective Photobiomodulation Therapy","Photobiomodulation therapy is the use of low-power light in biological tissues through a non-ionizing source of light (600 to 1.100 nm), with variable power between 1 and 500 mW and therapeutic goals.\n\nThis group will receive photobiomodulation from a whole-body panel of low intensity LEDs",[45],{"type":68,"name":73,"description":74,"armGroupLabels":75,"otherNames":32},"Sham Panel Photobiomodulation Therapy","Use of common red lamp to perform the sham photobiomodulation for the panel group",[51],{"type":68,"name":77,"description":78,"armGroupLabels":79,"otherNames":32},"Modified ILIB Sham Photobiomodulation Therapy","ILIB Therapy device turned off for the sham ILIB therapy",[62],{"type":68,"name":81,"description":82,"armGroupLabels":83,"otherNames":32},"Modified ILIB Photobiomodulation Therapy","Common laser used in ILIB mode for modified ILIB therapy",[57],[85],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Federal University of São Carlos","RECRUITING","São Carlos","São Paulo","13565-905","Brazil","BR",{"type":94,"coordinates":95},"Point",[96,97],-47.89083,-22.0175,{"lat":97,"lon":96},[100],{"name":101,"role":102,"phone":103,"phoneExt":32,"email":104},"Lara Espósito, PT","CONTACT","+551633518985","larabataglia@estudante.ufscar.br",{"type":106,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Lara Maria Bataglia Espósito","Physical Therapist, Master's student",[110],{"name":111,"class":112},"Fundação de Amparo à Pesquisa do Estado de São Paulo","OTHER_GOV","100568244",false,"NCT06678698","Acute Effect of Photobiomodulation in Individuals with Hypertension","Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Sedentary or irregularly inactive individuals (IPAQ)\n* Both sexes\n* Age between 40 to 60 years old\n* Clinical diagnosis of hypertension for at least 3 months with difficulty in blood pressure control\n* Hypertension classification up to stage 2\n* Individuals who have a prescription for hypertension control drugs and have been using these drugs for at least 3 months\n\nExclusion Criteria:\n\n* Diabetes diagnosis\n* Smokers\n* BMI \\> 30 kg\u002Fm²\n* Cardiac pacemaker use\n* Presence of arrhythmias or other decompensated cardiovascular diseases\n* Musculoskeletal, orthopedic or neurological conditions that make it unable to participate in the procedures\n* Presence of cognitive deficits that make it difficult to understand the assessments\n* Presence of active neoplasia, under suspicion or after 5 years in remission period\n* Presence of tattoos (covering a large body area, or the anterior wrist region)\n* Photosensitive drugs use\n* Pregnant women or under suspicion\n* Presence of epilepsy or seizures\n* Participants who present a systolic blood pressure ≥ 180 mmHg and\u002For diastolic blood pressure ≥ 110 mmHg on the day of the intervention","ALL","40 Years","60 Years",{"count":123,"type":124},48,"ESTIMATED","INTERVENTIONAL",[127],"NA","This is a randomized, double-blind and sham-controlled clinical trial that aims to evaluate and compare the acute effect of full-body photobiomodulation (PBM) and modified ILIB (Intravascular laser irradiation of blood) on blood pressure, endothelial function and arterial stiffness in individuals with hypertension. Participants (n=48) will be equally, randomly and secretly allocated into one of 4 groups: Panel Group; Panel Sham Group; Modified ILIB group; and Modified ILIB Sham Group. Participants aged 40 to 60 years old, diagnosed with hypertension and using control drugs for at least 3 months will be included. Participants will be assessed at pre- and post-intervention for: BP; endothelial function; arterial stiffness; blood nitrite; and thermography. In the post-intervention period, the ambulatory blood pressure monitoring will also be carried out. Participants will receive a single application of PBM, which, depending on the group, may be full-body irradiation from an LED panel (660 nm; 25.34 J\u002Fcm²; 42.24 mW\u002Fcm²), modified ILIB (660 nm; 42,462 J\u002Fcm²; 35.385 W\u002Fcm²), or the respective sham therapies. Data homogeneity and normality will be verified by the Levene and Shapiro-Wilk tests, which will determine the choice of subsequent tests. A statistical significance of 5% will be considered.",[130],"Hypertension",[132,133,134],"hypertension","photobiomodulation","low-level light therapy","2024-11-06",{"date":137,"type":138},"2024-11-08","ACTUAL",{"date":140,"type":138},"2024-05-01",{"date":142,"type":124},"2025-01-30",{"name":5,"class":6},1]