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