Reprogramming Insoles In Regulating Blood Pressure In Hypertensive Subjects — RIBP  

Hypertension Clinical Trial

Official title: Effect Of Postural Reprogramming Insoles In Regulating Blood Pressure, Posture And Quality Of Life In Hypertensive Subjects

Status Completed

Clinical Trial Summary

ASH has a high prevalence rates and considered one of the major modifiable risk factors for cardiac vascular diseases (CVD) and brain vascular diseases (BVD) and one of the most important public health problems. Researches estimated 62% of BVD can be attributed to ASH. In Brazil, prevalence of hypertension ranged from 21.6% in 2006 to 42.4% in 2011. CVD are responsible for high frequency of hospitalization, and in 2009, 91,970 hospitalizations due to CVD cost public treasury more than 165 million reais. 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.

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.

Clinical Trial Description

Posture can be defined as the way body acquires at any given time in relation to gravity line, and suffers influence of sensory information from different segments, organs and systems, integrated to cerebral cortex. Once information is associated, analyzed and compared, is sent to tonic and phasic-tonic muscles that will perform necessary adjustments to maintain posture.

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. ;

Related Conditions & MeSH terms

• Hypertension

• NCT number: NCT02401516
• Study type: Interventional
• Source: Escola Bahiana de Medicina e Saude Publica
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Completion date: December 2019