Chronic Obstructive Pulmonary DiseaseHBCOPDNCT01554072
Home-based in Chronic Obstructive Pulmonary Disease
A study testing Home based pulmonary rehabilitation with exercise in people with Chronic Obstructive Pulmonary Disease, run by University of Nove de Julho at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Home based pulmonary rehabilitation with exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based Pulmonary Rehabilitation in COPD
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.
Read the 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Home based pulmonary rehabilitation with exercise
- Keywords
- home-based, pulmonary rehabilitation, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based pulmonary rehabilitation with exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Other: Home based pulmonary rehabilitation with exercise |
| exercise | Active comparator | 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. Receives: Other: Home based pulmonary rehabilitation with exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After two months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Dultra Dias, University of Nove de Julho
- Investigators
- Fernanda Dias, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554072
- Sponsor's protocol ID
- 384767
- Other IDs
- pulmonary rehabilitation
- Acronym
- HBCOPD
- Status last verified
- Jun 2013
- First submitted
- 17 Jan 2012
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24235824
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Pulmonary Rehabilitation in COPD
- ClinicalTrials.gov ID
- NCT01554072
- Acronym / sponsor ID
- HBCOPD / 384767
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- home-based, pulmonary rehabilitation, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Home based pulmonary rehabilitation with exercisePatients 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. |
| exercise | Active comparator | Other: Home based pulmonary rehabilitation with exercisePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based pulmonary rehabilitation with exerciseAfter 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. | Other | Placebo, exercise |
Primary outcome
Change from baseline of functional capacity and quality of life after Home-based rehab
Time frame: After two months of treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- Derived from this study: PubMed 24235824Dias 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda Dias principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based pulmonary rehabilitation with exercise in people with Chronic Obstructive Pulmonary Disease, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of functional capacity and quality of life after Home-based rehab (time frame: After two months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01554072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.