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Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease (PR)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
upper limb exercises
without training for upper limb
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary rehabilitation, chronic obstructive pulmonary disease, physical ability, pulmonary function, quality of daily life

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of BahiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

without training for upper limb

upper limb exercises

Arm Description

Receive treatment from traditional pulmonary rehabilitation and without resistive training for upper limb (UL)

Receive the same treatment control with additional upper limb resistance training.

Outcomes

Primary Outcome Measures

Change in distance of the six-minute walk test
measure: metres

Secondary Outcome Measures

Change in quality of life
measured by questionnaire Saint George/ measure: points
Change in forced expiratory volume in one second
measurement: liters
Change in forced vital capacity
measurement: liters
Change in respiratory muscle strength
measurement: Water centimeter
repetition maximum (RM);
measurement: Kg

Full Information

First Posted
May 30, 2015
Last Updated
May 24, 2017
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT02468635
Brief Title
Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease
Acronym
PR
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pulmonary rehabilitation, chronic obstructive pulmonary disease, physical ability, pulmonary function, quality of daily life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
without training for upper limb
Arm Type
Other
Arm Description
Receive treatment from traditional pulmonary rehabilitation and without resistive training for upper limb (UL)
Arm Title
upper limb exercises
Arm Type
Other
Arm Description
Receive the same treatment control with additional upper limb resistance training.
Intervention Type
Other
Intervention Name(s)
upper limb exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
without training for upper limb
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in distance of the six-minute walk test
Description
measure: metres
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
measured by questionnaire Saint George/ measure: points
Time Frame
8 weeks
Title
Change in forced expiratory volume in one second
Description
measurement: liters
Time Frame
8 weeks
Title
Change in forced vital capacity
Description
measurement: liters
Time Frame
8 weeks
Title
Change in respiratory muscle strength
Description
measurement: Water centimeter
Time Frame
8 weeks
Title
repetition maximum (RM);
Description
measurement: Kg
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cássio Magalhães, research
Phone
+557199616304
Email
cassiofisio2@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Mansueto Neto, research
Phone
+557199188277
Email
netofisio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelmir Machado, research
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cássio Magalhães, research
Phone
+557199616304
Email
cassiofisio2@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Mansueto Neto, research
Phone
+557199188277
Email
netofisio@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease

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