Clinical trial NCT01295359: Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Impact of a Hospital Physical Therapy Program on Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Walking
Hospital
Exercise Tolerance
Physical Therapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2011-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  * Stroke
  * Epilepsy
* 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

Primary outcomes:
measure: Change in Exercise Capacity
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Change in BODE index
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
Secondary outcomes:
measure: Change in Perceived Dyspnea
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Change in Perceived discomfort in lower limbs
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Change in Variation in Heart Rate
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Change in the need of oxygen therapy
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Change in Handgrip Isometric Force
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Change in General Quality of Life
timeFrame: first day of the protocol and at the day of discharge
measure: Change in Body Composition
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Change in Forced Expiratory Volume in the First Second
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Days in hospital
timeFrame: At the discharge
measure: Change in Reported Dyspnea
timeFrame: Daily, as soon as medically appropriated, during the hospitalization
measure: Change in Heart Rate Variability
timeFrame: first day of the protocol and at the day of discharge
measure: Quadriceps Isometric Force
timeFrame: first day of the protocol and at the day of discharge
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Hospital Escola Municipal "Dr Horácio Carlos Panepucci
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Valéria Amorim Pires Di Lorenzo, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Sao Carlos
name: Adriana Sanches Garcia de Araujo, Masters
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Sao Carlos
name: Juliano Ferreira Arcuri, Especialist
role: PRINCIPAL_INVESTIGATOR
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