Reprogramming Insoles In Regulating Blood Pressure In Hypertensive Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Reprogramming insoles
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postural Reprogramming Insole; Blood Pressure; Posture; Quality Of Life; General Functional Capacity; Respiratory Muscles Strength; Flexibility; Arterial Systemic Hypertension