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临床试验/NCT01295359
NCT01295359Unknown不适用

Impact of a Hospital Physical Therapy Program on Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial

Universidade Federal de Sao Carlos2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Change in Exercise Capacity

研究概览

简要总结

The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and mortality, so it's important to find actions that could improve quality of life and decrease the mortality. The objective of this study is to verify if a ground walking program applied to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity, airways obstruction, body composition, heart rate variability, quadriceps isometric force and in the "Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index" (BODE index). An evaluators-blinded randomized controlled study will be conducted in "Hospital Escola Municipal de São Carlos" where forty patients will be recruited to participate. The volunteers will be randomized in two groups with twenty patients, the usual care group, that will receive only the usual care of the hospital; and the trained group that will receive the same care, but will also participate in a ground walking program associated with respiratory exercises. It will be evaluated, in the start and at the end of the program, the health related and general quality of life and the Barthel index. Daily, the patient will be submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test and to a dyspnea assessment, and will be calculated its BODE index. All patients will be invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would receive the same evaluation of the last day in the hospital. All the collected data will be expressed in means and standard deviations or medians and range when appropriated. It will be chosen appropriated tests to compare and correlate them.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD Patients (FEV1/FVC < 0,70; FEV1 > 30% and < 80%)
  • Hospitalized for exacerbation of COPD

排除标准

  • Conditions that could restrict walking
  • Skeletal-muscle and joint disturbs
  • Extreme Obesity (BMI > 35kg/m²)
  • Heart Failure (New York Heart Association class III and IV)
  • Uncontrolled infection (fever > 38ºC and leukocytosis > 10000 cels/dl)
  • Need of Invasive Mechanical Ventilation after the beginning of the program
  • Previous Diagnosis of:
  • Coagulation disorders (INR > 1,5 or platelets < 50.000/m³)
  • Psychiatric Disorders or severe agitation
  • Cardiac or respiratory instability
  • Oxygen therapy > 3L/min at rest
  • Respiratory Rate > 30 breaths/min at rest
  • Tachycardia and Bradycardia
  • Vasoactive Drugs need

结局指标

主要结局

Change in Exercise Capacity

时间窗: Daily, as soon as medically appropriated, during the hospitalization

It will be evaluated through the six minutes walking distance, performed according to ATS rules.

Change in BODE index

时间窗: Daily, as soon as medically appropriated, during the hospitalization

The Body-Mass Index, Airways Obstruction, Dyspnea, Exercise Capacity (BODE) index. This is a multidimensional evaluation that includes Forced Expiratory Volume in the first second, Body-Mass Index, 6 Minutes Walking Distance and mMRC score. It is an index to predict mortality.

次要结局

  • Change in Variation in Heart Rate(Daily, as soon as medically appropriated, during the hospitalization)
  • Change in the need of oxygen therapy(Daily, as soon as medically appropriated, during the hospitalization)
  • Change in Perceived Dyspnea(Daily, as soon as medically appropriated, during the hospitalization)
  • Change in General Quality of Life(first day of the protocol and at the day of discharge)
  • Change in Forced Expiratory Volume in the First Second(Daily, as soon as medically appropriated, during the hospitalization)
  • Quadriceps Isometric Force(first day of the protocol and at the day of discharge)
  • Change in Perceived discomfort in lower limbs(Daily, as soon as medically appropriated, during the hospitalization)
  • Change in Handgrip Isometric Force(Daily, as soon as medically appropriated, during the hospitalization)
  • Change in Body Composition(Daily, as soon as medically appropriated, during the hospitalization)
  • Days in hospital(At the discharge)
  • Change in Reported Dyspnea(Daily, as soon as medically appropriated, during the hospitalization)
  • Change in Heart Rate Variability(first day of the protocol and at the day of discharge)

研究者

发起方
Universidade Federal de Sao Carlos
申办方类型
Other

研究点 (2)

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