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Clinical Trials/NCT01295359
NCT01295359
Unknown
Not Applicable

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

Universidade Federal de Sao Carlos1 site in 1 country40 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Universidade Federal de Sao Carlos
Enrollment
40
Locations
1
Primary Endpoint
Change in Exercise Capacity
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
August 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidade Federal de Sao Carlos

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in Exercise Capacity

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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