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

May 24, 2017 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40110100
        • Recruiting
        • Federal University of Bahia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: without training for upper limb
Receive treatment from traditional pulmonary rehabilitation and without resistive training for upper limb (UL)
Other: without training for upper limb
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.
Other: upper limb exercises
Receive the same treatment control with additional upper limb resistance training.
Other: upper limb exercises
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in distance of the six-minute walk test
Time Frame: 8 weeks
measure: metres
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: 8 weeks
measured by questionnaire Saint George/ measure: points
8 weeks
Change in forced expiratory volume in one second
Time Frame: 8 weeks
measurement: liters
8 weeks
Change in forced vital capacity
Time Frame: 8 weeks
measurement: liters
8 weeks
Change in respiratory muscle strength
Time Frame: 8 weeks
measurement: Water centimeter
8 weeks
repetition maximum (RM);
Time Frame: 8 weeks
measurement: Kg
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Bahia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Adelmir Machado, research, Federal University of Bahia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ca141078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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