Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Walking, Hospital, Exercise Tolerance, Physical Therapy
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.
Interventions
OTHERGround Walking Program
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.
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Universidade Federal de Sao Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 |
| 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. |
| 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 Forced Expiratory Volume in the First Second | Daily, as soon as medically appropriated, during the hospitalization | It will be evaluated through espirometry |
| 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 |
Countries
Brazil
Contacts
Primary ContactJuliano Ferreira Arcuri, Especialist
Backup ContactAdriana Sanches Garcia de Araujo, Masters
Outcome results
None listed