Effect Of Postural Reprogramming Insoles In Regulating Blood Pressure, Posture And Quality Of Life In Hypertensive Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Blood Pressure Control by ABPM (Ambulatory Blood Pressure Monitoring) - mm Hg
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals diagnosed with hypertension (PAS≥140mmHg and PAD≥90mmHg), for at least two months
- •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
- •Individuals with neurological diseases, mental depression, renal failure, pregnancy and diabetes mellitus associated with hypertension,
- •With a history of previous cardiovascular event (myocardial infarction, heart failure, unstable angina, peripheral arterial disease)
- •Undertake regular exercise
Arms & Interventions
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.
Intervention: Reprogramming insoles (Device)
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.
Intervention: Reprogramming insoles (Device)
Outcomes
Primary Outcomes
Blood Pressure Control by ABPM (Ambulatory Blood Pressure Monitoring) - mm Hg
Time Frame: Baseline and after 6 weeks insoles
Subjects will undergo ABPM (Ambulatory Blood Pressure Monitoring), a technique that allows multiple indirect measurements of blood pressure for 24 or more consecutive hours with a minimum of discomfort during daily activities (MAPA, 2005). ABPM will be held by oscillometric method, BP measured every 15 minutes. ABPM will be used in accordance with ABPM I-II of IV Guideline tables. Subjects will also fill a diary of activities with data on symptoms and other situations that may modify BP. ABPM will be performed one day before PRI use to define baseline BP values, and six weeks after reassessment is performed using insole and is considered as endpoint the BP mean.
Secondary Outcomes
- Influence of posture alterations on blood pressure control in hypertensive individuals(Baseline)
- Compare estimated and predicted values of Six-minutes Walk Test.(Baseline)
- Composite Outcome measure - association between AMBP parameters and Global Muscle Strength(Baseline)
- Changing in Posture by Postural Assessment software (SAPO)(Baseline and 6 weeks)
- Composite Outcome measure - Association between Blood Pressure and Posture(6 weeks)
- Quality of Life domains(6 weeks)
- Compare estimated and predicted values of respiratory muscle strength.(Baseline)
- Composite Outcome measure - association between AMBP parameters and Respiratory Muscle Strength(Baseline)
- Description impact of High Blood Pressure by ABPM (Ambulatory Blood Pressure Monitoring)(Baseline and 6 weeks)
- Changing in Quality of Life by Mini-Questionnaire of Quality of Life in Hypertension: - MINICHAL-Brazil(Baseline and 6 weeks)
- Changing in Overall muscle strength by dynamometer Jamar® brand to measure grip strength.(Baseline and 6 weeks)
- Composite Outcome measure - association between double product parameters and Global Muscle Strength(Baseline)
- Changing in General Functional Capacity using the Six-minutes Walking Test protocol(Baseline and 6 weeks)
- Changing in Respiratory muscle strength by analog manometer Globalmed® brand.(Baseline and 6 weeks)
- Changing in Flexibility measured through Wells bank.(Baseline and 6 weeks)
- Flexibility parameters in hypertensive individuals(Baseline)
- Composite Outcome measure - association between AMBP parameters and functional capacity(Baseline)
- Composite Outcome measure - association between double product parameters and functional capacity(Baseline)
- Composite Outcome measure - association between double product parameters and Respiratory Muscle Strength(Baseline)
Investigators
ANA LUCIA BARBOSA GOES
PHYSICAL THERAPIST AND PROFESSOR AT ESCOLA BAHIANA DE MEDICINA E SAÚDE PÚBLICA
Escola Bahiana de Medicina e Saude Publica