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Reprogramming Insoles In Regulating Blood Pressure In Hypertensive Subjects

NCT02401516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Escola Bahiana de Medicina e Saude Publica

    lead OTHER

Principal Investigators

  • ANA MARICE T LADEIA, Doctorade · ESCOLA BAHIANA DE MEDICINA E SAÚDE PÚBLICA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401516 on ClinicalTrials.gov