- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02468635
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
2
Phase
- 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
- Name: Cássio Magalhães, research
- Phone Number: +557199616304
- Email: cassiofisio2@yahoo.com.br
Study Contact Backup
- Name: Mansueto Neto, research
- Phone Number: +557199188277
- Email: netofisio@gmail.com
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 40110100
- Recruiting
- Federal University of Bahia
-
Contact:
- Cássio Magalhães, research
- Phone Number: +557199616304
- Email: cassiofisio2@yahoo.com.br
-
Contact:
- Mansueto Neto, research
- Phone Number: +557199188277
- Email: netofisio@gmail.com
-
-
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
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 |
Intervention / Treatment |
---|---|
Other: 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.
|
Other: 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.
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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
June 1, 2015
Primary Completion (Anticipated)
June 1, 2017
Study Completion (Anticipated)
May 1, 2018
Study Registration Dates
First Submitted
May 30, 2015
First Submitted That Met QC Criteria
June 8, 2015
First Posted (Estimate)
June 11, 2015
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on without training for upper limb
-
The Hong Kong Polytechnic UniversityNot yet recruitingParkinson Disease | Electroencephalography | Acoustic Stimulation
-
The Hong Kong Polytechnic UniversityNot yet recruitingParkinson Disease | Movement, Abnormal | Bradykinesia | Acoustic Stimulation | Arm
-
University of Sao PauloUnknown
-
Université de SherbrookeMcGill University; Université de Montréal; Université du Québec à ChicoutimiCompleted
-
Université de MontréalCanadian Institutes of Health Research (CIHR)Completed
-
Federal State Budgetary Scientific Institution...CompletedPrevention of Diseases of the Musculoskeletal SystemRussian Federation
-
Riphah International UniversityNot yet recruitingPronator Teres SyndromePakistan
-
Beni-Suef UniversityCompletedEffect of Different Types of Aerobic Training on Diastolic Heart Failure PatientsEgypt
-
Taipei Medical University Shuang Ho HospitalNot yet recruiting
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium