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临床试验/NCT02783326
NCT02783326已完成不适用

Effects of a Protocol Of Rehabilitation in Patients With Chronic Disease Obstructive Pulmonary (COPD) Improvement Modulation Autonomic Heart Rate, Oxidative Stress, Quality of Life and Function

Universidade Metodista de Piracicaba2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Heart rate variability modulation

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a condition in which the lung is in chronic state due to an inflammatory response that leads to limitation in lung function of the individual, providing symptoms such as dyspnea, nutritional changes, decreased strength respiratory muscle, low capacity to exercise, dynamic insufflation and altered autonomic function with decreased heart rate variability. Have objective to evaluate and compare the effects of a rehabilitation protocol on autonomic modulation of heart rate. Participate in the study, 10 volunteers with COPD and 10 apparently healthy individuals, of both sexes, between 50 and 70 years old. Data collection and application of the Protocol will take place at the Clinical School of Physiotherapy and Occupational Therapy at the University of the Amazon (UNAMA). Between January and February 2015.

详细描述

The study is being conducted in the physiotherapy clinic of HUJBB. The sample is composed of 26 volunteers with moderate to severe COPD, of both genders, recruited from the population that will start the treatment in pulmonology HUJBB physiotherapy clinic.

All participants will undergo the assessment base used in HUJBB, blood analysis, heart rate variability, AQ20 questionary, 6-minute walk test and Pulmonary Rehabilitation Program.

The evaluation will be carried out by pre-existing general assessment form and used in hospital outpatient. The sheet contains: identification data; medical history; diagnosed diseases; Drug use; Use of oxygen; nutrition and exercise habits; Physical exam; Investigations; functional kinetic evaluation; Goals; treatment/management. Since these will only be used: identification data; diagnosed diseases; Use of Oxygen; nutrition and exercise habits and goals.

Morphological assessment of EOX in blood plasma is performed according to the test known as Optical Microscopy for cell analysis in vitro or HLB test, also known under the name Dry layer oxidative test, which the investigators refer to as microscopic morphology EOX in plasma (EEW). The EEW provides indirect information concerning EOX, among others, using the following grading system percentage of discontinuous area of the clot, present in the microscope slide: grade I (normal EOX rate, with total area of discontinuity of the extracellular matrix (ME) less than 10%), grade II (light EOX with ME discontinuity area between 10 to 20%), grade III (moderate EOX with ME discontinuity area between 20 to 30%), grade IV ( serious EOX with ME discontinuity area between 30 to 40%) and the grade V (very serious EOX with ME discontinuity area above 40%) 18. By lancing on the medial side of the digital pulp of the fourth finger of the left hand previously sanitized with alcohol, collecting the blood drop will be next to a microscope slide by five light touches this blade with the drop. After this procedure, the blade will be kept in place protected from contact with the blood and at room temperature (23 ° C) for the nine-minute period for the realization of the collected blood clotting process. At the end of this period, the morphological patterns of these clots are seen in an increase of 40 times as set out in protocolo18 and their assigned qualitative graduation will be logged into a spreadsheet for further statistical analysis.

The coagulated blood will be studied by Videomicroscopy (microscope NIPOM brand), which will be selected the best histological field, then a picture which will be analyzed by Image Pro Plus you see the fields where there is no blood coagulation will be made, and from this discontinuity the program will provide the percentage of oxidative stress. This analysis test allows you to have an indirect notion of oxidative stress level in the studied patient and to evaluate its therapeutic development.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • individuals who have been diagnosed with COPD , stage II and III disease
  • are undergoing treatment at the hospital João de Barros Barreto in the period January and February 2016
  • both sexes
  • 50 to 70 years of age
  • hemodynamically stable

排除标准

  • were not diagnosed with COPD
  • present associated diseases that may interfere with cardiac autonomic control,
  • had less than 50 years or over 70 years old
  • are in stage I of the COPD
  • in intensive care unit
  • present muscle skeletal deformities
  • hemodynamic instability
  • make use of pacemakers
  • in need of supplemental O2
  • who do not tolerate the practice of exercises

研究组 & 干预措施

COPD Group

Experimental

Evaluation of oxidative stress, heart rate variability, quality of life with AQ20 questionary, function with TC6 before the application of rehabilitation protocol, after 10 weeks during protocol application and 2 months after protocol application

干预措施: Rehabilitation (Other)

Control Group

Active Comparator

Evaluation of oxidative stress, heart rate variability, quality of life with AQ20 questionary, function with TC6 before the application of rehabilitation protocol, after 10 weeks during protocol application and 2 months after protocol application

干预措施: Rehabilitation (Other)

结局指标

主要结局

Heart rate variability modulation

时间窗: Change from baseline autonomic modulation at 2 months

Heart rate variability evaluation

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

Principal investigator

Universidade Metodista de Piracicaba

研究点 (2)

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