Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease (PR)
2017年5月24日 更新者:Cássio Magalhães da Silva e Silva、Federal University of Bahia
Analysis of Pulmonary Rehabilitation on the Physical Capacity and Pulmonary Function in Patients With Chronic Obstructive Pulmonary Disease Clinical Trial
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.
研究概览
详细说明
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).
研究类型
介入性
注册 (预期的)
2
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Bahia
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Salvador、Bahia、巴西、40110100
- 招聘中
- Federal University of Bahia
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接触:
- Cássio Magalhães, research
- 电话号码:+557199616304
- 邮箱:cassiofisio2@yahoo.com.br
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接触:
- Mansueto Neto, research
- 电话号码:+557199188277
- 邮箱:netofisio@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:without training for upper limb
Receive treatment from traditional pulmonary rehabilitation and without resistive training for upper limb (UL)
|
HEATING PHASE: diagonals for upper and lower limbs (5-10 minutes).
AEROBIC PHASE: aerobic exercise on a treadmill or bicycle between 5 - 30 minutes and rest 1-2 minutes according to the Borg scale and patient tolerance (Borg scores for dyspnea 4-5); RESPIRATORY TRAINING: Strengthening respiratory muscles 5-15 minutes with Threshold with load of 50% of MIP hit in the evaluation.
RELAXATION: Stretching and muscle massage therapy group involved in the 5-10 minute workout.
|
|
其他:upper limb exercises
Receive the same treatment control with additional upper limb resistance training.
|
HEATING PHASE: diagonals for upper and lower limbs (5-10 minutes).
AEROBIC PHASE: aerobic exercise on a treadmill or bicycle between 5 - 30 minutes and rest 1-2 minutes according to the Borg scale and patient tolerance (Borg scores for dyspnea 4-5); RESISTANCE STAGE: upper limb exercises with weight training equipment or dumbbells (the patient's adaptation) with 50% of maximum load reached the maximum repetition test.
Series 2 minutes and rest interval between sets 1-2 minutes.
RESPIRATORY TRAINING : Strengthening of the respiratory muscles 5-15 minutes with Threshold with load of 50% of the affected MIP (measure maximal inspiratory pressure) evaluation.
RELAXATION: Stretching and muscle massage therapy group involved in the 5-10 minute workout.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in distance of the six-minute walk test
大体时间:8 weeks
|
measure: metres
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in quality of life
大体时间:8 weeks
|
measured by questionnaire Saint George/ measure: points
|
8 weeks
|
|
Change in forced expiratory volume in one second
大体时间:8 weeks
|
measurement: liters
|
8 weeks
|
|
Change in forced vital capacity
大体时间:8 weeks
|
measurement: liters
|
8 weeks
|
|
Change in respiratory muscle strength
大体时间:8 weeks
|
measurement: Water centimeter
|
8 weeks
|
|
repetition maximum (RM);
大体时间:8 weeks
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measurement: Kg
|
8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Adelmir Machado, research、Federal University of Bahia
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年6月1日
初级完成 (预期的)
2017年6月1日
研究完成 (预期的)
2018年5月1日
研究注册日期
首次提交
2015年5月30日
首先提交符合 QC 标准的
2015年6月8日
首次发布 (估计)
2015年6月11日
研究记录更新
最后更新发布 (实际的)
2017年5月30日
上次提交的符合 QC 标准的更新
2017年5月24日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ca141078
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