Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Ground Walking Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trained Group<br>This group will receive the usual care of the hospital and a ground walking training program associated with respiratory exercises. | Other: Ground Walking Program<br>* The patients will walk on a corridor, for 40min, once a day. The speed will be controlled through a metronome, that will be programed to a frequency of steps/min determinated as 80% of the mean frequency of steps performed in six minutes walk test of that day. The 40min will be divided in 3min of walk and 2min of rest, totalizing 24min of exercise and 16min of rest. Furthermore, these patients, in sitting position, will receive orientation to do calm and slow inspirations and expirations, associated with pursed lips expiration. They will try to maintain its Respiratory Rate in 6bpm, during four minutes.<br>* Other names: Respiratory Rehabilitation;|
| No Intervention: Usual Care Group<br>This group will only receive the usual care of the hospital, including physical therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exercise Capacity | It will be evaluated through the six minutes walking distance, performed according to ATS rules. | Daily, as soon as medically appropriated, during the hospitalization | 
| Change in BODE index | 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. | Daily, as soon as medically appropriated, during the hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Dyspnea | Dyspnea during the six minutes walk test through the BORG CR10 scale | Daily, as soon as medically appropriated, during the hospitalization | 
| Change in Perceived discomfort in lower limbs | Evaluated during the six minutes walk test through the BORG CR10 scale | Daily, as soon as medically appropriated, during the hospitalization | 
| Change in Variation in Heart Rate | It will be evaluated the variation in the Heart Rate during the six minutes walk test (Exercise Peak - rest) | Daily, as soon as medically appropriated, during the hospitalization | 
| Change in the need of oxygen therapy | Will be evaluated the need of oxygen therapy during the six minutes walk test | Daily, as soon as medically appropriated, during the hospitalization | 
| Change in Handgrip Isometric Force | It will be evaluated through a hand grip dynamometer. | Daily, as soon as medically appropriated, during the hospitalization | 
| Change in General Quality of Life | It will be evaluated through the SF-36 questionnaire | first day of the protocol and at the day of discharge | 
| Change in Body Composition | 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. | Daily, as soon as medically appropriated, during the hospitalization | 
| Change in Forced Expiratory Volume in the First Second | It will be evaluated through espirometry | Daily, as soon as medically appropriated, during the hospitalization | 
| Days in hospital |  | At the discharge | 
| Change in Reported Dyspnea | It will be evaluated through the Modified Medical Research Concil Questionnaire | Daily, as soon as medically appropriated, during the hospitalization | 
| Change in Heart Rate Variability | It will be recorded through a cardiac monitor, and analized in the time and frequency domain, and non-linear analysis. | first day of the protocol and at the day of discharge | 
| Quadriceps Isometric Force | It will be evaluated through a hand held dynamometer. | first day of the protocol and at the day of discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Walking, Hospital, Exercise Tolerance, Physical Therapy