Reprogramming Insoles In Regulating Blood Pressure In Hypertensive Subjects
NCT ID: NCT02401516
Last Updated: 2020-01-18
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-05-31
2019-12-31
Brief Summary
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Pathways used by SANS for immediate control of BP (wich are reticulate formation, bulb and cortex) appear to be similar to pathways used for postural control reflex (reticulate formation, bulb, cortex, among others), which are also used by Postural Reprogramming Insoles (PRI) for posture adequacy. Due to this similarity in reflex activation areas, it is believed that PRI may have some effect on BP regulation.
There are many ways to treat postural changes and one of them is posturology, which is based on therapeutic use of postural reprogramming insoles (PRI). PRI activates tonic-postural system, rebalancing muscles, joints and bony structures of body segments, and returning individual to an appropriate posture.
The PRI is composed of a central artifact, situated in reflex zone full of somatosensory stimuli captors, which generates a frequency of vibration that promotes postural adaptation.
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Detailed Description
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When sensory information captured by body are unbalanced, body reacts to this information with deformities and misalignment like flat feet, scoliosis, among others. Posturology is a way of treating these alignment changes, which is based on use of postural reprogramming insoles (PRI) to return individual to an appropriate posture. The PRI is composed of a central artifact which stimulates autonomic system, via tonic postural system, promoting posture adaptation/regulation.
What is not known, though, is the influence of these insoles on other systems such as cardiovascular system and on other conditions, such as arterial systemic hypertension (ASH), a multifactorial clinical condition characterized by high and constant levels of blood pressure (BP).
ASH neurological pathophysiology studies has shown that excessive activation of sympathetic autonomic nervous system (SANS) seems to have an important role in genesis and maintenance of ASH, with current studies aimed to understand this relationship.
Previous studies indicate that, despite efforts to understand and control arterial systemic hypertension, rates of ASH control are low and some difficulties are listed such as: access to health services and medications, adherence to guidelines, quantity of medication usage, non-controlling hypertension even on medication, family help regarding treatment, difficulty in maintaining regular practice of physical exercise. Therefore, it is necessary to encourage dietary control, increased patient support and new forms of affordable and effective non-pharmacological treatment, in addition to measuring the impact disease causes in life and living of those patients.
Arterial Systemic Hypertension impacts physical health, psychological well-being, longevity and quality of life (QOL), and therefore should quality of life be an important criterion for studying, once it can be used as indicator of impacts that illness can provoke in individuals as well as provide data about individual adaptation.
Quality of life (QOL) is defined by WHO as the "individual's perception of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectations, standards and concerns".
Health-related quality of life (HRQOL) is evaluated based on objective and measurable data, applied to sick people to identify committed dimensions and discomfort degree associated with limitation disease and/or therapy can cause. Thus, health professionals can effectively measure impact of interventions on health-related quality of life.
Instruments that assess HRQOL are usually questionnaires that must go through a validation process for language-country, in this case Portuguese.
From all HRQOL questionnaires validated in Brazil, there is one specific to assess quality of life in hypertension individuals, called Mini-Questionnaire Quality of Life in Hypertension - MINICHAL, which was developed in Spain in 2001, and validated in Brazil in 2007.
THEORETICAL RATIONALE Imbalances that affect posture are a reflection of asymmetry in Tonic Postural System (TPS). The simplified model of organization of STP states that equilibrium depends on the fascia and muscles viscoelastic system to maintain balance against body mass actions, gravity, and height.
In a standing position, fascia is not able to overcome forces opposing gravity, lonely, requiring joint muscle action to balance forces on body.
Posture can be classified as appropriate or inappropriate. When sensory information captured by body are symmetrical and well organized, tonic-postural system reaction generates minimal overload of bone, joint and myofascial structures, producing a lower energy expenditure for maintenance of these structures, favoring relative alignment to gravity and individual has an appropriated posture.
If sensory information, captured by body are unbalanced, inconsistent and disorganized, tonic-postural system requires more of muscles, joints, fascia and bone structures, to keep body segments reacting to gravity force. It creates a disharmonious relationship of various parts of body, producing a greater burden in supporting structures and a less efficient body balance on their stand weight basis, creating greater energy expenditure, misalignment and deformities like flat feet, knees valgus, scoliosis, among others and then person has poor posture.
During motion, there is a predicted movement and movement that is actually done. Between these two points there is cerebellum, which is the structure that compares predicted and performed movements by promoting postural adjustments, carried out so that movement is close to what was expected. Cerebellum organizes, provides, adjusts and modifies movement.
Adaptation system function to get body back into balance in cases of imbalance, which can be both internal and external. Terminal system adaptation is foot and therefore there is no reprogramming in TPS without focusing foot, with use of postural reprogramming insole (PRI).
PRI artifact is formed by two crossed polarizing devices, which creates a electrogalvanic field that loads and unloads, causing vibration that integrates with energy field of individual. This integration leads to a permanent posture recalibration, aligning individual in relation to gravity forces with consequent improvement of postural changes secondary to imbalances.
These sensory stimuli use SANS to stimulate areas of brain such as cerebellum, vestibular nuclei, basal nuclei (BN), reticulate formation of bulb and frontal premotor cortex to cause posture correction.
BP control is also related to SANS, which uses nerve reflex by stimulating baroreceptors, located in arteries walls and when distended, as happens in high BP, send signals to glossopharyngeal nerve and reticular formation of medulla, brain stem, causing inhibition of vasoconstrictor center and exciting vagal center, with consequent: vasodilation of veins and arterioles, decreased heart rate (HR) and heart contraction force, leading to fall reflex of BP due to decreased peripheral resistance and cardiac debit, respectively.
However, what seems to occur as shown in recent studies is the existence of a constant activation / stimulation of vasoconstrictor center in hypertensive individuals, causing BP to remain at high levels.
Stimulation of vasoconstrictor center suffers influence of SANS, which uses areas of reticulate formation, bulb and cerebral cortex, which areas appear to be similar to those used for reflex control of posture (reticulate formation, bulb, cortex, among others), which are also used by PRI for posture correction. Due to this similarity in areas of reflex activation, it is believed that PRI may have some effect on BP regulation.
Once occurring regulation of blood pressure due to use of PRI and improved posture, it is expected a positive effect on health-related quality of life of hypertensive patients.
Mini-Questionnaire Quality of Life in Hypertension - MINICHAL-Brazil suffered cultural adaptation and validation into Portuguese, which was tested for content, construct and internal consistency of instrument, comparing outcomes in hypertensive patients and patients with normal BP. Subsequently, other studies have been published testing concurrent validity by comparing Minichal with two other questionnaires used in many researches in Brazil: Short Form 36 (SF-36) and the WHOQOL questionnaire (WHOQOL-Bref), showing significant correlation to both questionnaires, making a specific tool for assessing health-related quality of life in hypertensive population.
Whereas many studies have been developed in the later stages of hypertension and impairments in functional capacity, respiratory and locomotor were observed in these stages; Whereas it is a chronic and systemic condition of progressive evolution; Whereas this study addresses a hypertensive population stage I and II without target organ injury; it is important to identify if in the early stages of this condition (stages I and II) it is possible to observe changes in above mentioned systems, identifying effects of hypertension in functional capacity, respiratory and locomotor systems, not only with character of prevention, but also for early diagnosis and prognosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Reprogramming Insoles
EG - experimental group. Subjects will be subjected to the use of insoles with the artifact in the postural reprogramming insole that emits a electrogalvanic stream. Volunteers of this research must use the insole for at least 12 hours a day and have usage control through a daily chart.
Reprogramming insoles
1)Answer demographic, lifestyle and health questionnaire; 2)Weight and height evaluation; 3)ABPM (Ambulatory Blood Pressure Monitoring) and diary of activities assessment; 4)Postural Assessment software (SAPO), created by São Paulo's University (USP), which assesses posture through full body images of people with marked bone prominences on the body in all planes of motion. Images are captured by a Sony Cybershot 14 Megapixel camera, supported on a tripod, placed three meters away from the subject and at half its height. 5)Six-Minutes Walk Test in accordance with Britto and Souza25 and American Thoracic Society guidelines43; 6)analog manometer Globalmed® brand to assess respiratory muscle strength; 7)Dynamometer Jamar® brand to measure grip strength; 8)Wells bank to evaluate Flexibility.
Neutral Insoles
CG - control group. Subjects will be subjected to the use of insoles likewise the ones used by EG, but instead the artifact in the postural reprogramming insole made of metal, will be made of cork.
Reprogramming insoles
1)Answer demographic, lifestyle and health questionnaire; 2)Weight and height evaluation; 3)ABPM (Ambulatory Blood Pressure Monitoring) and diary of activities assessment; 4)Postural Assessment software (SAPO), created by São Paulo's University (USP), which assesses posture through full body images of people with marked bone prominences on the body in all planes of motion. Images are captured by a Sony Cybershot 14 Megapixel camera, supported on a tripod, placed three meters away from the subject and at half its height. 5)Six-Minutes Walk Test in accordance with Britto and Souza25 and American Thoracic Society guidelines43; 6)analog manometer Globalmed® brand to assess respiratory muscle strength; 7)Dynamometer Jamar® brand to measure grip strength; 8)Wells bank to evaluate Flexibility.
Interventions
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Reprogramming insoles
1)Answer demographic, lifestyle and health questionnaire; 2)Weight and height evaluation; 3)ABPM (Ambulatory Blood Pressure Monitoring) and diary of activities assessment; 4)Postural Assessment software (SAPO), created by São Paulo's University (USP), which assesses posture through full body images of people with marked bone prominences on the body in all planes of motion. Images are captured by a Sony Cybershot 14 Megapixel camera, supported on a tripod, placed three meters away from the subject and at half its height. 5)Six-Minutes Walk Test in accordance with Britto and Souza25 and American Thoracic Society guidelines43; 6)analog manometer Globalmed® brand to assess respiratory muscle strength; 7)Dynamometer Jamar® brand to measure grip strength; 8)Wells bank to evaluate Flexibility.
Eligibility Criteria
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Inclusion Criteria
* Both sexes,
* Between 30-60 years;
* Living in Salvador and metropolitan area,
* Body mass index (BMI) to 29.9kg / m2,
* In regular use of anti-hypertensive drugs
Exclusion Criteria
* With a history of previous cardiovascular event (myocardial infarction, heart failure, unstable angina, peripheral arterial disease)
* Undertake regular exercise
30 Years
60 Years
ALL
No
Sponsors
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Escola Bahiana de Medicina e Saude Publica
OTHER
Responsible Party
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ANA LUCIA BARBOSA GOES
PHYSICAL THERAPIST AND PROFESSOR AT ESCOLA BAHIANA DE MEDICINA E SAÚDE PÚBLICA
Principal Investigators
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ANA MARICE T LADEIA, Doctorade
Role: PRINCIPAL_INVESTIGATOR
ESCOLA BAHIANA DE MEDICINA E SAÚDE PÚBLICA
Locations
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Escola Bahiana de Medicina E Saúde Pública
Salvador, Estado de Bahia, Brazil
Countries
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References
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Kavounoudias A, Roll R, Roll JP. The plantar sole is a 'dynamometric map' for human balance control. Neuroreport. 1998 Oct 5;9(14):3247-52. doi: 10.1097/00001756-199810050-00021.
Ribot-Ciscar E, Roll JP. Ago-antagonist muscle spindle inputs contribute together to joint movement coding in man. Brain Res. 1998 Apr 27;791(1-2):167-76. doi: 10.1016/s0006-8993(98)00092-4.
Villechevrolle, O. Influence des semelles of reprogrammation posturale globale sur les tests oculomoteurs réalisés sur une des sujets présentant disfonction cranio-mandibulaire.Thèse, Nantes, 1994a
Villechevrolle, O. Influence des semelles of reprogrammation posturale globale sur le test de Fukuda. Diplôme d'Université mémoire of the Parodontologie et d'occluso, Nantes, 1994b.
Mallong SP. Étude prospective longitudinal suivi par of pacientes douloureux au cours d'une Reprogrammation posturale Globale (RPG). Résonances Européennes du Rachis. 2006; 14 (42): 1753-6.
Brazilian Society of Cardiology / Brazilian Society of Hypertension / Brazilian Society of Nephrology. VI Brazilian Guidelines on Hypertension. Arq Bras Cardiol 2010; 95 (1 suppl.1): 1-51
Ferreira SR, Moura EC, Malta DC, Sarno F. Frequency of arterial hypertension and associated factors: Brazil, 2006. Rev Saude Publica. 2009 Nov;43 Suppl 2:98-106. doi: 10.1590/s0034-89102009000900013. English, Portuguese.
Piccini RX, Facchini LA, Tomasi E, Siqueira FV, Silveira DS, Thume E, Silva SM, Dilelio AS. Promotion, prevention and arterial hypertension care in Brazil. Rev Saude Publica. 2012 Jun;46(3):543-50. doi: 10.1590/s0034-89102012005000027. Epub 2012 Apr 17. English, Portuguese.
Lopes MC, Marcon SS. [Arterial hypertension in the family: the need for family care]. Rev Esc Enferm USP. 2009 Jun;43(2):343-50. doi: 10.1590/s0080-62342009000200013. Portuguese.
Schulz RB, Rossignoli P, Correr CJ, Fernandez-Llimos F, Toni PM. Validation of the short form of the Spanish hypertension quality of life questionnaire (MINICHAL) for Portuguese (Brazil). Arq Bras Cardiol. 2008 Feb;90(2):127-31. doi: 10.1590/s0066-782x2008000200010. English, Portuguese.
Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
Colne P, Frelut ML, Peres G, Thoumie P. Postural control in obese adolescents assessed by limits of stability and gait initiation. Gait Posture. 2008 Jul;28(1):164-9. doi: 10.1016/j.gaitpost.2007.11.006. Epub 2008 Jan 10.
Roll JP, Bergenheim M, Ribot-Ciscar E. Proprioception Muscle afferents Sensory coding
Kavounoudias A, Roll R, Roll JP. Foot sole and ankle muscle inputs contribute jointly to human erect posture regulation. J Physiol. 2001 May 1;532(Pt 3):869-78. doi: 10.1111/j.1469-7793.2001.0869e.x.
Roll R, Kavounoudias A, Roll JP. Cutaneous afferents from human plantar sole contribute to body posture awareness. Neuroreport. 2002 Oct 28;13(15):1957-61. doi: 10.1097/00001756-200210280-00025.
Grassi G, Seravalle G, Quarti-Trevano F. The 'neuroadrenergic hypothesis' in hypertension: current evidence. Exp Physiol. 2010 May;95(5):581-6. doi: 10.1113/expphysiol.2009.047381. Epub 2009 Dec 11.
Fisher JP, Fadel PJ. Therapeutic strategies for targeting excessive central sympathetic activation in human hypertension. Exp Physiol. 2010 May;95(5):572-80. doi: 10.1113/expphysiol.2009.047332. Epub 2010 Mar 19.
Tsioufis C, Kordalis A, Flessas D, Anastasopoulos I, Tsiachris D, Papademetriou V, Stefanadis C. Pathophysiology of resistant hypertension: the role of sympathetic nervous system. Int J Hypertens. 2011 Jan 20;2011:642416. doi: 10.4061/2011/642416.
Bruno RM, Ghiadoni L, Seravalle G, Dell'oro R, Taddei S, Grassi G. Sympathetic regulation of vascular function in health and disease. Front Physiol. 2012 Jul 24;3:284. doi: 10.3389/fphys.2012.00284. eCollection 2012.
Cavalcante MA, Bombig MT, Luna Filho B, Carvalho AC, Paola AA, Povoa R. Quality of life of hypertensive patients treated at an outpatient clinic. Arq Bras Cardiol. 2007 Oct;89(4):245-50. doi: 10.1590/s0066-782x2007001600006. English, Portuguese.
Related Links
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List of validated instruments of BP assessment
Other Identifiers
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CAAE 16952113.5.0000.5544
Identifier Type: -
Identifier Source: org_study_id
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