Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Other: Ground Walking Program
- Registration Number
- NCT01295359
- Lead Sponsor
- Universidade Federal de Sao Carlos
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- COPD Patients (FEV1/FVC < 0,70; FEV1 > 30% and < 80%)
- Hospitalized for exacerbation of COPD
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Conditions that could restrict walking
- Skeletal-muscle and joint disturbs
- Extreme Obesity (BMI > 35kg/m²)
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Heart Failure (New York Heart Association class III and IV)
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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
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Respiratory Rate > 30 breaths/min at rest
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Tachycardia and Bradycardia
-
Vasoactive Drugs need
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trained Group Ground Walking Program This group will receive the usual care of the hospital and a ground walking training program associated with respiratory exercises.
- Primary Outcome Measures
Name Time Method Change in Exercise Capacity 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 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 Outcome Measures
Name Time Method Change in Variation in Heart Rate Daily, as soon as medically appropriated, during the hospitalization It will be evaluated the variation in the Heart Rate during the six minutes walk test (Exercise Peak - rest)
Change in the need of oxygen therapy Daily, as soon as medically appropriated, during the hospitalization Will be evaluated the need of oxygen therapy during the six minutes walk test
Change in Perceived Dyspnea Daily, as soon as medically appropriated, during the hospitalization Dyspnea during the six minutes walk test through the BORG CR10 scale
Change in General Quality of Life first day of the protocol and at the day of discharge It will be evaluated through the SF-36 questionnaire
Change in Forced Expiratory Volume in the First Second Daily, as soon as medically appropriated, during the hospitalization It will be evaluated through espirometry
Quadriceps Isometric Force first day of the protocol and at the day of discharge It will be evaluated through a hand held dynamometer.
Change in Perceived discomfort in lower limbs Daily, as soon as medically appropriated, during the hospitalization Evaluated during the six minutes walk test through the BORG CR10 scale
Change in Handgrip Isometric Force Daily, as soon as medically appropriated, during the hospitalization It will be evaluated through a hand grip dynamometer.
Change in Body Composition Daily, as soon as medically appropriated, during the hospitalization It will be performed through a body composition monitor, evaluating weight, body Fat percentage, Muscle Mass, Basal Metabolic Rate, Bone Mass and Total Body Water Percentage.
Days in hospital At the discharge Change in Reported Dyspnea Daily, as soon as medically appropriated, during the hospitalization It will be evaluated through the Modified Medical Research Concil Questionnaire
Change in Heart Rate Variability first day of the protocol and at the day of discharge It will be recorded through a cardiac monitor, and analized in the time and frequency domain, and non-linear analysis.
Trial Locations
- Locations (1)
Hospital Escola Municipal "Dr Horácio Carlos Panepucci
🇧🇷São Carlos, São Paulo, Brazil