Clinical trial NCT02468635: Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease
Official title: Analysis of Pulmonary Rehabilitation on the Physical Capacity and Pulmonary Function in Patients With Chronic Obstructive Pulmonary Disease Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary rehabilitation
chronic obstructive pulmonary disease
physical ability
pulmonary function
quality of daily life
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) is characterized by the obstruction is not fully reversible airway, where the severity of the disease and the prognosis is not determined solely by changes in lung function. Pulmonary rehabilitation is a multidisciplinary program of care for patients with chronic respiratory diseases, individually designed to optimize physical and social performance and autonomy of these patients, promoting improvement in functional exercise capacity, quality of life, reducing dyspnea, frequency and duration of hospitalizations and reduce the frequency of exacerbations of the disease. The overall objective of the research is to evaluate the effects of pulmonary rehabilitation program on exercise capacity, lung function, quality of daily life and reduction of dyspnea in patients with COPD. A study type randomized, open-label trial following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials) will be held. The study will be conducted at the Clinic Physiotherapy Course of the School with a sample of 58 patients. The intervention will be performed sessions three times a week for 16 weeks (8 weeks for assessment and 8 weeks for adaptation and (pulmonary rehabilitation training). The PR (pulmonary rehabilitation) will last 60-120 minutes each.O group A (control) will receive treatment of traditional pulmonary rehabilitation and without resistive training for upper limb (UL) and group B will receive the same treatment control with additional training of upper limb strength.

Detailed description: Chronic obstructive pulmonary disease (COPD) is characterized by the obstruction is not fully reversible airway, where the severity of the disease and the prognosis is not determined solely by changes in lung function. Pulmonary rehabilitation is a multidisciplinary program of care for patients with chronic respiratory diseases, individually designed to optimize physical and social performance and autonomy of these patients, promoting improvement in functional exercise capacity, quality of life, reducing dyspnea, frequency and duration of hospitalizations and reduce the frequency of exacerbations of the disease. It is still reported in the survey improved ability to perform activities of daily life, exercise capacity, quality of life, reduction in respiratory symptoms, anxiety and depression in patients with chronic lung diseases. The overall objective of the research is to evaluate the effects of pulmonary rehabilitation program on exercise capacity, lung function, quality of daily life and reduction of dyspnea in patients with COPD. A study type randomized, open-label trial following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials) will be held. The study will be conducted at the Clinical Department of Physical Therapy School The calculation of the sample held at LEE program (epidemiology laboratory and statistics) with 95% confidence interval and allowing a loss of 20% the sample then goes to 58 patients. Inclusion criteria: Patients with COPD eligible to moderate COPD according to the criteria of gold GOLD (Global Initiative for Chronic Obstructive Lung Disease) as well as being ex-smokers and no exacerbation of the disease in the last three months. Accompanied by a pulmonologist. Age between 40-85 years. Be not practicing physical activity and without cardiovascular or orthopedic disease, make use of bronchodilators and oral theophylline, oxygen therapy or corticosteroids. Exclusion criteria: Patients who have comorbidities musculoskeletal, peripheral saturation of oxygen fall lower than 90% during the 6 minute walk test (six) minutes. Difficulty cognitive understanding of body awareness. The evaluation procedure will be: functional independence measure (FIM); london chest activity of daily living (LCADL); scale medical research council (MRC); the world health organization disability assessment schedule 2.0 (WHODAS 2.0); anthropometric examination; walk test of six (6) minutes; step test; As the repetition maximum (RM); muscle activation - electromyography; grip strength of the upper limbs (DMS); ultrasound diaphragm dynamometer; spirometry; respiratory muscle strength; saint george in respiratory disease questionnaire (SGRQ). The intervention will be performed sessions three times a week for 16 weeks (8 weeks for assessment and 8 weeks for adaptation and PR training). PR will last from 60 to 120 minutes each. Patients who agree to participate and the PR will be divided into two groups randomly through enveloped draw. Group A (control) will receive treatment from traditional pulmonary rehabilitation and without resistive training for upper limb (UL) and group B will receive the same treatment control with additional upper limb resistance training. For data analysis continuous variables will be analyzed with central tendency and dispersion measures, data or dichotomous categorical variables will be analyzed frequently measures. For the realization of inferential statistics are. Since the data are normally distributed, the Student t test for independent samples. The Mann-Whitney test is used to compare the differences in the means of the variables between the groups. To analyze the correlation between the functional capacity variables and QOL will be used in calculating the Pearson correlation coefficient (r) if the data are normally distributed and the calculation of the Spearman correlation coefficient was not distributed normally. To evaluate the reliability will be used the coefficient of intra-class correlation coefficient (ICC). Statistical analysis will be performed using the Statistical Package for Social Sciences for Windows (version 17.0).

Eligibility criteria: Inclusion Criteria:

* Patients with COPD eligible to moderate COPD according to the criteria of gold GOLD (Global Initiative for Chronic Obstructive Lung Disease) and who had post-bronchodilator spirometry results in the last year of FEV1 (forced expiratory volume in one second) / FVC (forced vital capacity) \<0.7 and FEV1 between 50% and 80% of previsto.
* Besides being former smokers for at least three months and were clinically stable, no disease exacerbation in the past three months.
* Accompanied by a pulmonologist.
* Age between 40-85 years.
* They are not practicing physical activity.
* Without cardiovascular or orthopedic disease that makes it impossible to perform the exercises of the RP protocol.
* Without presenting other comorbidities that put them at risk during the exercises .
* Use of bronchodilators and oral theophylline, oxygen therapy or corticosteroids.

Exclusion Criteria:

* Patients who have musculoskeletal comorbidities that interfere with walking or performing upper extremity exercises.
* lower peripheral saturation decrease of oxygen lower than 90% during the 6 minute walk test (six) minutes.
* Presenting difficulty of cognitive understanding of body awareness and the ability to recall information for the questionnaire responses applied in the evaluation and re-evaluation in addition to this also children, adolescents and legally incapable

Primary outcomes:
measure: Change in distance of the six-minute walk test
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in quality of life
timeFrame: 8 weeks
measure: Change in forced expiratory volume in one second
timeFrame: 8 weeks
measure: Change in forced vital capacity
timeFrame: 8 weeks
measure: Change in respiratory muscle strength
timeFrame: 8 weeks
measure: repetition maximum (RM);
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Federal University of Bahia
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Adelmir Machado, research
role: STUDY_DIRECTOR
References: