PneumoniaNCT01017081
Chest Physiotherapy in Pediatrics Patients With Pneumonia
A study testing Physiotherapy and Positioning and cough in people with Pneumonia, run by Santa Casa de Porto Alegre at 1 site in Brazil.
Trial summary
Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Physiotherapy and Positioning and cough
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2001to Sep 2002
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours)
Who cannot join
- Severely ill patients (hospitalized in intensive care units)
- Pleural effusion treated with chest drainage
- Atelectasis detected by x-ray
- Pneumonia or pleural effusion in the previous six months
- Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Porto Alegre
Posto Alegre, Rio Grande do Sul, 90020-160
About this study
Official title: Chest Physiotherapy in Pediatric Patients Hospitalised With Community-acquired Pneumonia: a Randomized Clinical Trial
Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.
- Conditions
- Pneumonia
- Being tested
- Physiotherapy, Positioning and cough
- Keywords
- physiotherapy, children, clinical trial
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Physiotherapy: three times per day, for 10 to 12 minutes, during hospital admission
Positioning and coughOther
Non-mandatory request to maintain lateral positioning to improve air exchange and cough
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Non-mandatory request to maintain lateral positioning to improve air exchange, to cough in order to clear secretion, and to perform diaphragmatic and deep breathing, for five minutes, once a day, during hospital stay. Receives: Other: Positioning and cough |
| Physiotherapy | Experimental | Physiotherapy: Children younger than 5 years: Manual Thoracic vibration (TV), thoracic compression (TC), positive expiratory pressure (PEP), and forced exhalation with the glottis open ("huffing"). Children aged 5 years or older: same procedures in addition to the ventilatory patterns, and a forced expiratory technique (FET), consisting of one or two "huffs" (forced expirations) followed by a period of relaxed, controlled diaphragmatic breathing, three times per day, for 10 to 12 minutes, during hospital admission. Receives: Other: Physiotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startSep 2001
- Primary completionSep 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Casa de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017081
- Sponsor's protocol ID
- FISIOPUL
- Status last verified
- Nov 2009
- First submitted
- 19 Nov 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Physiotherapy in Pediatric Patients Hospitalised With Community-acquired Pneumonia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01017081
- Acronym / sponsor ID
- FISIOPUL
- Conditions
- Pneumonia
- Keywords
- physiotherapy, children, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Santa Casa de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Sep 2001
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 20 Nov 2009 (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.
Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Positioning and coughNon-mandatory request to maintain lateral positioning to improve air exchange, to cough in order to clear secretion, and to perform diaphragmatic and deep breathing, for five minutes, once a day, during hospital stay. |
| Physiotherapy | Experimental | Other: PhysiotherapyPhysiotherapy: Children younger than 5 years: Manual Thoracic vibration (TV), thoracic compression (TC), positive expiratory pressure (PEP), and forced exhalation with the glottis open ("huffing"). Children aged 5 years or older: same procedures in addition to the ventilatory patterns, and a forced expiratory technique (FET), consisting of one or two "huffs" (forced expirations) followed by a period of relaxed, controlled diaphragmatic breathing, three times per day, for 10 to 12 minutes, during hospital admission. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours)
Key exclusion criteria (5 listed)
- Severely ill patients (hospitalized in intensive care units)
- Pleural effusion treated with chest drainage
- Atelectasis detected by x-ray
- Pneumonia or pleural effusion in the previous six months
- Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency
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 |
|---|---|---|
| PhysiotherapyPhysiotherapy: three times per day, for 10 to 12 minutes, during hospital admission | Other | Physiotherapy |
| Positioning and coughNon-mandatory request to maintain lateral positioning to improve air exchange and cough | Other | Control |
Primary outcome
Not reported in the source record.
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 20 Nov 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Positioning and cough in people with Pneumonia, run by Santa Casa de Porto Alegre 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 1 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 20 Nov 2009. 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. 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.
Where can I read the original study information?
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 20 Nov 2009.