Reprogramming Insoles In Regulating Blood Pressure In Hypertensive Subjects

NCT02401516 | Completed DMC

• 1 other identifier: CAAE 16952113.5.0000.5544
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Postural Reprogramming Insole; Blood Pressure; Posture; Quality Of Life; General Functional Capacity; Respiratory Muscles Strength; Flexibility; Arterial Systemic Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Control by ABPM (Ambulatory Blood Pressure Monitoring) - mm Hg

  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.

  Baseline and after 6 weeks insoles

Secondary Outcomes (19)

• Influence of posture alterations on blood pressure control in hypertensive individuals

  Baseline

• Composite Outcome measure - Association between Blood Pressure and Posture

  6 weeks

• Quality of Life domains

  6 weeks

• Description impact of High Blood Pressure by ABPM (Ambulatory Blood Pressure Monitoring)

  Baseline and 6 weeks

• Compare estimated and predicted values of Six-minutes Walk Test.

  Baseline

Study Arms (2)

Reprogramming Insoles

ACTIVE COMPARATOR

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.

Device: Reprogramming insoles

Neutral Insoles

PLACEBO COMPARATOR

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.

Device: Reprogramming insoles

Interventions

Reprogramming insoles DEVICE

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; Reprogramming Insoles

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Escola Bahiana de Medicina e Saude Publica: lead

Study Sites (1)

Escola Bahiana de Medicina E Saúde Pública

Salvador, Estado de Bahia, 40.000-000, Brazil

Location

Related Publications (20)

• 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.

  PMID: 9831459 BACKGROUND

• 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.

  PMID: 9593876 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 19936504 BACKGROUND

• 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.

  PMID: 22510974 BACKGROUND

• 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.

  PMID: 19655675 BACKGROUND

• 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.

  PMID: 18392385 BACKGROUND

• 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.

  PMID: 9626712 BACKGROUND

• 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.

  PMID: 18191568 BACKGROUND

• Roll JP, Bergenheim M, Ribot-Ciscar E. Proprioception Muscle afferents Sensory coding

  RESULT

• 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.

  PMID: 11313452 RESULT

• 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.

  PMID: 12395099 RESULT

• 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.

  PMID: 20008032 RESULT

• 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.

  PMID: 20304932 RESULT

• 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.

  PMID: 21331155 RESULT

• 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.

  PMID: 22934037 RESULT

• 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.

  PMID: 17992381 RESULT

Related Links

• List of validated instruments of BP assessment

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• ANA MARICE T LADEIA, Doctorade

  ESCOLA BAHIANA DE MEDICINA E SAÚDE PÚBLICA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHYSICAL THERAPIST AND PROFESSOR AT ESCOLA BAHIANA DE MEDICINA E SAÚDE PÚBLICA

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 30, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)