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临床试验/NCT03829709
NCT03829709已完成不适用

Electromiography Study in the Respiratory Muscle Training in Human Lymphotropic Virus Type 1

Universidade Metodista de Piracicaba2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Inspiratory and expiratory muscle force

研究概览

简要总结

The main objective of the research will be to analyze, through surface electromyography, the impact of inspiratory muscle training before a supervised home training protocol in patients with human T-cell lymphotropic virus type 1 (HTLV-1). For this, a clinical, longitudinal, prospective, quantitative and single center trial will be carried out, aiming at home inspiratory muscle training lasting 5 weeks, 3 times a week, 30 minutes daily through the IMT Threshold, with 14 volunteers enrolled in the Laboratory of Studies in Functional Rehabilitation (LAERF) of the Federal University of Pará (UFPA). They will be classified as the manifestation of Tropical Spastic Paraparesis / Myelopathy (PET / MAH) for GP (PET / MAH probable) and GD (PET / MAH definitive) groups, obeying inclusion criteria. For characterization of expiratory flow rates and flows, as well as respiratory muscle strength, they will be submitted to spirometry and manovacuometry, pre, per, and post treatment, respectively. For the analysis of the electromyographic activity, the diaphragm, parasternal and sternocleidomastoid muscles will be counted in the follow-up during the analysis of inspiratory muscle strength, as well as once a week during the conduction of the inspiratory muscle training protocol. The collected data will be stored in a Microsoft Office Excel® 2010 worksheet and then submitted to statistical analysis using the Bioestat 5.0® program, adopting a standard error of 5%. The theoretical support of the research will have a bibliographical survey of scientific articles collected during the design of the project, and the accomplishment of the research. It is expected to map, through the surface electromyographic study, the impact of respiratory muscle training at a distance on the inspiratory muscle strength of patients with HTLV-I virus with probable or definitive PET / MAH.

详细描述

Human T-lymphotropic viruses, HTLV (Human Lymphotrophic Virus T), are retroviruses, which stand out as type 1 (HTLV-1) and type 2 (HTLV-2), the former being the etiologic agent of serious organ diseases such as leukemia adult T-cell lymphoma (ATLL), a neurological disorder, Tropical Spastic Paraparesis / HTLV-I-associated myelopathy (PET / HAM) and other non-malignant ophthalmologic, dermatological, rheumatic and osteomyelitis non-malignant disorders. For HTLV-2 it has not yet separated with some disease.

The highest prevalence of virus is found in countries of the Caribbean, South America, Melanesia Islands, West Africa and Japan. Brazil is an endemic country for infection and prevalence varies from state to state, being highest in Bahia, Pernambuco and Pará. The form of sexual transmission, hematologic for blood transfusions or accompanied by contaminated needles, mother-to-child verticalization, the passage of the lymphocyte infected by breast milk and also in the perinatal period.

The mechanism of the disease comes from the infection of several types of cells, such as T and B lymphocytes, monocytes and fibroblasts. However, its tropism is by TCD4 + cells. The form of contamination is cell-cell, thus being transferred from infected material to uninfected cells, modifying the immune system, as well as cell cells.

The main characteristic of HTLV infection is that in most cases the virus persists asymptomatic and undetectable by the immune system per year or until death in about 98% of the patients, while the hosts are able to transmit the virus. There are still no basic surveys on how severe forms of symptoms of graves occur in those infected.

In this context, when the individual becomes symptomatic, he is affected by chronic infection that may be associated with disabling diseases that compromise quality of life, such as the neurological disease PET-MAH. The onset is insidious with frequent changes in gait and urinary symptoms, mainly affecting the lower limbs such as spasticity, hyperreflexia, sensory-motor dysfunctions such as neuropathic or nociceptive pain, paresis, paralysis and paresthesia, urinary bladder disorders, muscle weakness and low back pain. The early diagnosis of motor complications in the face of the onset of neurological disease also contributes to the prevention of the installation of motor sensory sequelae if the physiotherapeutic treatment is established early. According to this reference, one of the aspects of preventive care refers to the functional autonomy correlated with physical conditioning in order to increase the strength and / or endurance of the skeletal muscles.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • volunteers of both sexes
  • HTLV-1 positive serology with definitive or probable PET / MAH

排除标准

  • pulmonary diseases
  • serious comorbidities such as heart disease and uncontrolled arterial hypertension
  • cognitive alterations that impede the conduction of the protocol

结局指标

主要结局

Inspiratory and expiratory muscle force

时间窗: Five weeks

The evaluation of respiratory muscle strength will be performed by measuring the maximal inspiratory pressure (PiMáx) and expiratory (PeMAx) measurements with manovacuometer (+ - 300cmH2O). In order to perform the measurement of PiMáx and PeMáx, referring to inspiratory and expiratory muscle strength respectively. The values can range from 0 to 300 cmH2O, being 0 no strength and 300 maximum respiratory muscle strength.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Santiago Barbosa Rocha, Phd

Director of Human Movement Department

Universidade Metodista de Piracicaba

研究点 (2)

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