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Home-based in Chronic Obstructive Pulmonary Disease (HBCOPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Home based pulmonary rehabilitation with exercise

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring home-based, pulmonary rehabilitation, COPD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

will be included patients of both sexes,
over 40 years and diagnosis of COPD according to criteria of ATS, GOLD and II Brazilian Consensus of COPD.
must be medically stable,
without having presented the framework of exacerbation of disease over the past 30 days and,
must have agreed to participate in this study which, after being presented and explained to patients, this accepted should be confirmed by Subscription Term of free and informed consent, pursuant to resolution 96 of 1996 of MS.

Exclusion Criteria:

will be excluded from the study patients with serious comorbidity,
orthopedic diseases such as heart defects in upper and lower limbs,
sequelae of motor neurological disorders or impaired that may interfere with the ability to carry out physical exercise,
uncontrolled hypertension,
lung diseases and
those who do not grant support to participation in this study.

Sites / Locations

University Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

exercise

Arm Description

Patients will receive a booklet of exercises, besides containing an explanation of his illness and the importance of exercise in their quality of life, an exercise routine physical to be held three times a week for two consecutive months. Patients will be instructed individually on each exercise, performing with supervisor that there be no doubt about execution, thereby minimizing any possible mistake in practice at home. For each day of the year ended data should be recorded in a daily monitoring. At the end of two months of the PR program semi-home patients will be subject to review so that all tests should be applied again.

Patients will receive a booklet of exercises, besides containing an explanation of his illness and the importance of exercise in their quality of life, an exercise routine physical to be held three times a week for two consecutive months. For each day of the year ended data should be recorded in a daily monitoring. Is also scheduled a visit to the laboratory biweekly in which patients demonstrate their exercise routine program RP semi-home settings for any load, postural corrections and execution of physical exercise, should be refocused. At the end of two months of the PR program semi-home patients will be subject to review so that all tests should be applied again.

Outcomes

Primary Outcome Measures

Change from baseline of functional capacity and quality of life after Home-based rehab

Observe the effectiveness of home rehabilitation on functional capacity and quality of life among the placebo group and intervention as well as pre and post assessment patient care intervention group

Secondary Outcome Measures

Full Information

NCT ID

NCT01554072

First Posted

January 17, 2012

Last Updated

June 24, 2013

Sponsor

University of Nove de Julho

1. Study Identification

Unique Protocol Identification Number

NCT01554072

Brief Title

Home-based in Chronic Obstructive Pulmonary Disease

Acronym

HBCOPD

Official Title

Home-based Pulmonary Rehabilitation in COPD

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Nove de Julho

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Pulmonary rehabilitation consists of a multidisciplinary program of care for patients with chronic respiratory disease, which currently encompasses numerous features and physical training methods aimed at maintaining stability clinic for people with Chronic Obstructive Pulmonary Disease (COPD), especially in patients who, even with optimized clinical treatment, continue their decline and symptomatic physical functions and 8 so that these social. goals are achieved the patient with COPD should integrate into a program of RP assiduous and with accompanying several times per week, for several months, which for a number of factors is not always possible. For this reason, it is the research of methodology of RP that hold their effectiveness, but with greater flexibility and viability to people with COPD. On this basis, this study aims to investigate the effectiveness of a program of RP semi-domiciliar in which the patient suffering from COPD can receive guidance and training in person, to develop it partially in own domicile.

Detailed Description

The protocol of the experimental procedure will begin with the explanation of the purpose, risks and benefits of the study volunteers to patients with COPD. Subsequently, based on an evaluation form, will collect data on the past history and current disease and performed a general physical examination. Then the patients will respond to two questionnaires. The first will research the Medical Council (MRC) 13, which is a dyspnea scale to categorize in terms of disability, patients with COPD. The second questionnaire will be the Airway Questionnaire 20 (AQ20) 14 specific for obstructive pulmonary disease, which is validated for the local language and highly reliable for the evaluation of patients with COPD, containing 20 questions related to respiratory health to evaluate the quality of life. Subsequently, the same day, the patients carry out the following tests: spirometry, respiratory muscle strength, respiratory muscle endurance, assessment of training load of the upper and shuttle test and bioimpedance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

home-based, pulmonary rehabilitation, COPD

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

exercise

Arm Type

Active Comparator

Arm Description

Patients will receive a booklet of exercises, besides containing an explanation of his illness and the importance of exercise in their quality of life, an exercise routine physical to be held three times a week for two consecutive months. For each day of the year ended data should be recorded in a daily monitoring. Is also scheduled a visit to the laboratory biweekly in which patients demonstrate their exercise routine program RP semi-home settings for any load, postural corrections and execution of physical exercise, should be refocused. At the end of two months of the PR program semi-home patients will be subject to review so that all tests should be applied again.

Intervention Type

Other

Intervention Name(s)

Home based pulmonary rehabilitation with exercise

Intervention Description

After each group will receive the randomization their booklets containing the exercise routine that should be performed at home., to be held three times a week for two consecutive months. Is also scheduled a visit to the laboratory biweekly Respiratory Functional Assessment in which patients demonstrate their exercise routine program RP semi-home settings for any load, postural corrections and execution of physical exercise, should be refocused.

Primary Outcome Measure Information:

Title

Change from baseline of functional capacity and quality of life after Home-based rehab

Description

Observe the effectiveness of home rehabilitation on functional capacity and quality of life among the placebo group and intervention as well as pre and post assessment patient care intervention group

Time Frame

After two months of treatment

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: will be included patients of both sexes, over 40 years and diagnosis of COPD according to criteria of ATS, GOLD and II Brazilian Consensus of COPD. must be medically stable, without having presented the framework of exacerbation of disease over the past 30 days and, must have agreed to participate in this study which, after being presented and explained to patients, this accepted should be confirmed by Subscription Term of free and informed consent, pursuant to resolution 96 of 1996 of MS. Exclusion Criteria: will be excluded from the study patients with serious comorbidity, orthopedic diseases such as heart defects in upper and lower limbs, sequelae of motor neurological disorders or impaired that may interfere with the ability to carry out physical exercise, uncontrolled hypertension, lung diseases and those who do not grant support to participation in this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernanda Dias

Organizational Affiliation

University of Nove de Julho

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Nove de Julho

City

São Paulo

ZIP/Postal Code

03121020

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

24235824

Citation

Dias FD, Sampaio LM, da Silva GA, Gomes EL, do Nascimento ES, Alves VL, Stirbulov R, Costa D. Home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized clinical trial. Int J Chron Obstruct Pulmon Dis. 2013;8:537-44. doi: 10.2147/COPD.S50213. Epub 2013 Nov 5.

Results Reference

derived

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Home-based in Chronic Obstructive Pulmonary Disease

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