Lower Respiratory Tract InfectionsNCT02053870
Lung Sounds as Indicators of Severity and Recovery of Lung Disease
A study testing Physiotherapy+conventional treatment and Conventional treatment in people with Lower Respiratory Tract Infections, run by Aveiro University at 1 site in Portugal.
Trial summary
This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in patients with lower respiratory tract infection (LRTI). Patients will be recruited from a central Hospital and their demographic and anthropometric data, lung sounds, lung function, breathlessness, oxygen saturation and chest… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract Infections
- What is being tested?
- Physiotherapy+conventional treatment and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2009to Mar 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of LRTI according to the international guidelines (i.e., presence cough and at least one of the following symptoms: sputum, dyspnoea, wheezes or chest pain)
- ≥ 18 years old
- able to provide their own informed consent
Who cannot join
- cognitive impairments
- inability to understand and co-operate
- bedridden or complete dependence on a wheelchair
- score >2 in the CURB criteria
- presence of severe comorbidities (e.g., past history of pulmonary lobectomy and current history of neoplasia, tuberculosis or other infectious disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adventitious Lung Sounds as Indicators of Severity and Recovery of Lung Pathology and Sputum Location
This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in patients with lower respiratory tract infection (LRTI).
Patients will be recruited from a central Hospital and their demographic and anthropometric data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will be collected within 24h of the first appointment. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus respiratory physiotherapy. Conventional treatment will consist on daily medical treatment prescribed by the physician. Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.
It is expected that ALS will be responsive to changes in patients' lung function after treatment. It is also expected that, by including a respiratory physiotherapy component in the treatment of patients with LRTI, they will express more improvements in a shorter period of time.
Read the detailed description
Respiratory problems are a significant burden to patients of all ages suffering from the most different pathologies and to their respective families, with enormous economic costs. Thus, respiratory therapies, physical (such as airway clearance therapy) or chemical (such as medication or inhalation therapies) are of increasing importance. However, little is known about the effectiveness of respiratory therapies due to the lack of accuracy, reliability and sensitivity of the current outcome measures used. Adventitious lung sounds (i.e., wheezes and crackles) have been shown to be objective, reliable measure and a sensitive indicator of minor alterations in airway geometry. Using wheezes' and crackles' analysis, the detection and characterization of the severity of the lung disease may be performed before any other measure. However, studies assessing the responsiveness to change of the ALS have never been conducted and are deemed necessary to assess if ALS are an appropriate outcome measure to overcome the problems recognized in the other clinical measures.
Therefore the main aim of this project is to assess and interpret the responses of lung sounds to respiratory interventions. To achieve this aim, high resolution computed tomography (HRCT), which is the gold standard to assess lung diseases, will be performed.
The specific aims of the study are:
- to explore ALS as indicators of severity and recovery of lung disease comparing acoustic data from the lungs with lung HRCT images and with the other measures i.e. breathlessness, oxygen saturation and lung function data )pre/post respiratory treatments);
- to explore ALS data as indicators of sputum movement comparing acoustic with imaging analysis;
- to explore respiratory physiotherapy effectiveness in patients with LTRI.
The plan is to recruit approximately 100 voluntary patients with LRTI attending to casualty at a central hospital. This study will enroll adult patients diagnosed with LRTI according to the international guidelines. The age and pathology of the participants have been chosen because i) adult patients are easier to collaborate; ii) there is some characterization based on ALS of adult patients allowing future comparisons; iii) this pathology normally benefit from medical and respiratory physiotherapy treatments as soon as the diagnose is made, but in Portugal do not often received respiratory physiotherapy. Furthermore, these patients will be able to cooperate with the data collection, namely with the imaging techniques, which is fundamental to assess the responsiveness to change of a measure.
Patients will be recruited via the physician, who will provide brief explanation of the study. Then, the researcher will contact interested participants to provide more detailed information and obtained the consent forms. Patients' who agree to participate will be randomly assigned to the conventional treatment group or the conventional treatment plus respiratory physiotherapy group (approximately 50 patients in each group).
Baseline data will be collected within the first 24 hours of patients' visit to the hospital. The researcher will collect some clinical information, socio-demographic, anthropometric, breathlessness and peripheral oxygen saturation of all participants. A multi-channel system with 7 microphones (attached to the patients' chest) will be connected to a laptop and will be used to record the lung sounds data. Patients will then lie down in supine on the machine plinth and a HRCT scan of the chest will be acquired. Lung function and exercise tolerance data will then be recorded.
Patients in the experimental group will receive daily medical treatment and respiratory physiotherapy 3 times a week, during 2 weeks (average time to treat the LRTI). Respiratory physiotherapy will consist of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease. This program will be adjusted to each individual needs. After this period all measurements will be repeated. Furthermore, all measures with the exception of the chest images will also be performed before/after each respiratory physiotherapy session to monitor the intervention. Each session will be conducted in property equipped rooms and will last approximately 60 minutes.
To identify change in the lung sounds, statistical techniques (e.g. ALS, intra-class correlation coefficient, Bland and Altmand 95% limits of agreements and smallest real difference) will be used. The relationship between the images and the sounds will be explored and defined analytically and quantitatively. To analyse changes in outcome measures, data from the two groups will be compared at baseline and 3 weeks after the intervention.
The data analysis will be undertaken using proprietary software packages (e.g.Matlab, SPSS) and will include the generation of descriptive statistics, and the use of existing and custom routines for hypothesis testing and signal processing and analysis.
- Conditions
- Lower Respiratory Tract Infections
- Being tested
- Physiotherapy+conventional treatment, Conventional treatment
- Keywords
- Adventitious lung sounds, Crackles, Wheezes, Sputum location
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy+conventional treatmentOther
Patients will be treated with daily medication prescribed by the physician, during 3 weeks. Additionally, they will be involved in 9 sessions (3 times a week during 2 weeks) of respiratory physiotherapy including breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.
Conventional treatmentDrug
Patients will be treated with daily medication prescribed by the physician, during 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy+conventional treatment | Experimental | Patients will be treated with daily medication prescribed by the physician, during 3 weeks. Additionally, they will be involved in 9 sessions (3 times a week during 2 weeks) of respiratory physiotherapy including breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease. Receives: Other: Physiotherapy+conventional treatment |
| Conventional treatment | Active comparator | Patients will be treated with daily medication prescribed by the physician, during 3 weeks. Receives: Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adventitious lung sounds
Adventitious lung sounds are sounds superimposed on the normal respiratory sound. There are continuous (wheezes) and discontinuous (crackles) adventitious sounds. The presence of adventitious lung sound generally indicates pulmonary disorders.
Measured: 24 hours after hospital presentation (baseline) and 3 weeks after intervention
Secondary outcomes (5)
Change in High Resolution Computed Tomography (HRCT scans)
Radiation levels were kept to the minimum needed to visualize the images properly and perform image computation.
Measured: assessment at baseline and 3 weeks after intervention
Change in exercise tolerance
Patients' exercise tolerance will be assessed with the 6-minute walk test. The maximal distance walked during 6 minutes and the associated respiratory symptoms will be collected.
Measured: assessment at baseline and 3 weeks after intervention
Change in activities limitation resulting from breathlessness
The Modified British Medical Research Council questionnaire comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
Measured: assessment at baseline and 3 weeks after intervention
Change in lung function
Lung function tests will be performed with a portable spirometer to assess the degree of bronchial obstruction or restriction
Measured: assessment at baseline and 3 weeks after intervention
Change in peripheral oxygen saturation
Peripheral Oxygen Saturation will be assessed with a pulse oximeter
Measured: assessment at baseline and 3 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startSep 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract InfectionsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda S. Marques, PhD, Principal investigator, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053870
- Sponsor's protocol ID
- PTDC/SAU-BEB/101943/2008
- Status last verified
- Feb 2014
- First submitted
- 31 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oliveira A, Pinho C, Monteiro S, Marcos A, Marques A. Usability testing of a respiratory interface using computer screen and facial expressions videos. Comput Biol Med. 2013 Dec;43(12):2205-13. doi: 10.1016/j.compbiomed.2013.10.010. Epub 2013 Oct 17.
PubMed 24290937Marques A, Oliveira A, Jacome C. Computerized adventitious respiratory sounds as outcome measures for respiratory therapy: a systematic review. Respir Care. 2014 May;59(5):765-76. doi: 10.4187/respcare.02765. Epub 2013 Sep 17.
PubMed 24046460Marques A, Pinho C, De Francesco S, Martins P, Neves J, Oliveira A. A randomized controlled trial of respiratory physiotherapy in lower respiratory tract infections. Respir Med. 2020 Feb;162:105861. doi: 10.1016/j.rmed.2019.105861. Epub 2020 Jan 1.
PubMed 31916533Oliveira A, Marques A. Exploratory mixed methods study of respiratory physiotherapy for patients with lower respiratory tract infections. Physiotherapy. 2016 Mar;102(1):111-8. doi: 10.1016/j.physio.2015.03.3723. Epub 2015 May 14.
PubMed 26067286
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adventitious Lung Sounds as Indicators of Severity and Recovery of Lung Pathology and Sputum Location
- ClinicalTrials.gov ID
- NCT02053870
- Acronym / sponsor ID
- PTDC/SAU-BEB/101943/2008
- Conditions
- Lower Respiratory Tract Infections
- Keywords
- Adventitious lung sounds, Crackles, Wheezes, Sputum location
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- Sep 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Feb 2014 (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.
This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in patients with lower respiratory tract infection (LRTI).
Patients will be recruited from a central Hospital and their demographic and anthropometric data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will be collected within 24h of the first appointment. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus respiratory physiotherapy. Conventional treatment will consist on daily medical treatment prescribed by the physician. Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.
It is expected that ALS will be responsive to changes in patients' lung function after treatment. It is also expected that, by including a respiratory physiotherapy component in the treatment of patients with LRTI, they will express more improvements in a shorter period of time.
Detailed description
Respiratory problems are a significant burden to patients of all ages suffering from the most different pathologies and to their respective families, with enormous economic costs. Thus, respiratory therapies, physical (such as airway clearance therapy) or chemical (such as medication or inhalation therapies) are of increasing importance. However, little is known about the effectiveness of respiratory therapies due to the lack of accuracy, reliability and sensitivity of the current outcome measures used. Adventitious lung sounds (i.e., wheezes and crackles) have been shown to be objective, reliable measure and a sensitive indicator of minor alterations in airway geometry. Using wheezes' and crackles' analysis, the detection and characterization of the severity of the lung disease may be performed before any other measure. However, studies assessing the responsiveness to change of the ALS have never been conducted and are deemed necessary to assess if ALS are an appropriate outcome measure to overcome the problems recognized in the other clinical measures.
Therefore the main aim of this project is to assess and interpret the responses of lung sounds to respiratory interventions. To achieve this aim, high resolution computed tomography (HRCT), which is the gold standard to assess lung diseases, will be performed.
The specific aims of the study are:
- to explore ALS as indicators of severity and recovery of lung disease comparing acoustic data from the lungs with lung HRCT images and with the other measures i.e. breathlessness, oxygen saturation and lung function data )pre/post respiratory treatments);
- to explore ALS data as indicators of sputum movement comparing acoustic with imaging analysis;
- to explore respiratory physiotherapy effectiveness in patients with LTRI.
The plan is to recruit approximately 100 voluntary patients with LRTI attending to casualty at a central hospital. This study will enroll adult patients diagnosed with LRTI according to the international guidelines. The age and pathology of the participants have been chosen because i) adult patients are easier to collaborate; ii) there is some characterization based on ALS of adult patients allowing future comparisons; iii) this pathology normally benefit from medical and respiratory physiotherapy treatments as soon as the diagnose is made, but in Portugal do not often received respiratory physiotherapy. Furthermore, these patients will be able to cooperate with the data collection, namely with the imaging techniques, which is fundamental to assess the responsiveness to change of a measure.
Patients will be recruited via the physician, who will provide brief explanation of the study. Then, the researcher will contact interested participants to provide more detailed information and obtained the consent forms. Patients' who agree to participate will be randomly assigned to the conventional treatment group or the conventional treatment plus respiratory physiotherapy group (approximately 50 patients in each group).
Baseline data will be collected within the first 24 hours of patients' visit to the hospital. The researcher will collect some clinical information, socio-demographic, anthropometric, breathlessness and peripheral oxygen saturation of all participants. A multi-channel system with 7 microphones (attached to the patients' chest) will be connected to a laptop and will be used to record the lung sounds data. Patients will then lie down in supine on the machine plinth and a HRCT scan of the chest will be acquired. Lung function and exercise tolerance data will then be recorded.
Patients in the experimental group will receive daily medical treatment and respiratory physiotherapy 3 times a week, during 2 weeks (average time to treat the LRTI). Respiratory physiotherapy will consist of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease. This program will be adjusted to each individual needs. After this period all measurements will be repeated. Furthermore, all measures with the exception of the chest images will also be performed before/after each respiratory physiotherapy session to monitor the intervention. Each session will be conducted in property equipped rooms and will last approximately 60 minutes.
To identify change in the lung sounds, statistical techniques (e.g. ALS, intra-class correlation coefficient, Bland and Altmand 95% limits of agreements and smallest real difference) will be used. The relationship between the images and the sounds will be explored and defined analytically and quantitatively. To analyse changes in outcome measures, data from the two groups will be compared at baseline and 3 weeks after the intervention.
The data analysis will be undertaken using proprietary software packages (e.g.Matlab, SPSS) and will include the generation of descriptive statistics, and the use of existing and custom routines for hypothesis testing and signal processing and analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy+conventional treatment | Experimental | Other: Physiotherapy+conventional treatmentPatients will be treated with daily medication prescribed by the physician, during 3 weeks. Additionally, they will be involved in 9 sessions (3 times a week during 2 weeks) of respiratory physiotherapy including breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease. |
| Conventional treatment | Active comparator | Drug: Conventional treatmentPatients will be treated with daily medication prescribed by the physician, during 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of LRTI according to the international guidelines (i.e., presence cough and at least one of the following symptoms: sputum, dyspnoea, wheezes or chest pain)
- ≥ 18 years old
- able to provide their own informed consent
Key exclusion criteria (5 listed)
- cognitive impairments
- inability to understand and co-operate
- bedridden or complete dependence on a wheelchair
- score >2 in the CURB criteria
- presence of severe comorbidities (e.g., past history of pulmonary lobectomy and current history of neoplasia, tuberculosis or other infectious disease)
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 |
|---|---|---|
| Physiotherapy+conventional treatmentPatients will be treated with daily medication prescribed by the physician, during 3 weeks. Additionally, they will be involved in 9 sessions (3 times a week during 2 weeks) of respiratory physiotherapy including breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease. | Other | Physiotherapy+conventional treatment |
| Conventional treatmentPatients will be treated with daily medication prescribed by the physician, during 3 weeks. | Drug | Conventional treatment |
Primary outcome
Change in adventitious lung sounds
Time frame: 24 hours after hospital presentation (baseline) and 3 weeks after intervention
Adventitious lung sounds are sounds superimposed on the normal respiratory sound. There are continuous (wheezes) and discontinuous (crackles) adventitious sounds. The presence of adventitious lung sound generally indicates pulmonary disorders.
5 secondary outcomes
Change in High Resolution Computed Tomography (HRCT scans)
Time frame: assessment at baseline and 3 weeks after intervention
Change in exercise tolerance
Time frame: assessment at baseline and 3 weeks after intervention
Change in activities limitation resulting from breathlessness
Time frame: assessment at baseline and 3 weeks after intervention
Change in lung function
Time frame: assessment at baseline and 3 weeks after intervention
Change in peripheral oxygen saturation
Time frame: assessment at baseline and 3 weeks after intervention
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 4 Feb 2014.
- Background: PubMed 24290937Oliveira A, Pinho C, Monteiro S, Marcos A, Marques A. Usability testing of a respiratory interface using computer screen and facial expressions videos. Comput Biol Med. 2013 Dec;43(12):2205-13. doi: 10.1016/j.compbiomed.2013.10.010. Epub 2013 Oct 17.
- Background: PubMed 24046460Marques A, Oliveira A, Jacome C. Computerized adventitious respiratory sounds as outcome measures for respiratory therapy: a systematic review. Respir Care. 2014 May;59(5):765-76. doi: 10.4187/respcare.02765. Epub 2013 Sep 17.
- Derived from this study: PubMed 31916533Marques A, Pinho C, De Francesco S, Martins P, Neves J, Oliveira A. A randomized controlled trial of respiratory physiotherapy in lower respiratory tract infections. Respir Med. 2020 Feb;162:105861. doi: 10.1016/j.rmed.2019.105861. Epub 2020 Jan 1.
- Derived from this study: PubMed 26067286Oliveira A, Marques A. Exploratory mixed methods study of respiratory physiotherapy for patients with lower respiratory tract infections. Physiotherapy. 2016 Mar;102(1):111-8. doi: 10.1016/j.physio.2015.03.3723. Epub 2015 May 14.
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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.
Alda S. Marques, PhD principal investigator
Aveiro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy+conventional treatment and Conventional treatment in people with Lower Respiratory Tract Infections, run by Aveiro University at 1 site in Portugal.
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 3 inclusion and 5 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 4 Feb 2014. 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 Portugal. 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. 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 in adventitious lung sounds (time frame: 24 hours after hospital presentation (baseline) and 3 weeks after intervention). 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 NCT02053870, which also lists 4 linked publications.
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 4 Feb 2014.