PneumoniaVAPNCT03343717
Physiotherapy on Pneumonia in Childrens
A study testing Rehabilitation and Chest physical therapy in people with Pneumonia, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
The children's susceptibility to respiratory problems is due to their anatomical and physiological characteristics; therefore, children with more severe clinical conditions may undergo invasive mechanical ventilation (IMV). Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Rehabilitation and Chest physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2017to 1 Jul 2020
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients on invasive or non-invasive mechanical ventilation for less than 96 hours
- with pneumonia due to invasive mechanical ventilation,
- aged between 1 year and 8 years
Who cannot join
- Severe Respiratory Failure
- active bleeding
- acute cerebral disorder
- presence of orthopedic contraindications (bone fractures, dislocations, subluxations, postoperative, unstable spine)
- neurological impairment with minimal functionality
- neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fundação Santa Casa de Misericórdia do Pará
Belém, Pará, 66.050-380
About this study
Official title: Effects of Early Mobilization in Children With Pneumonia
The children's susceptibility to respiratory problems is due to their anatomical and physiological characteristics; therefore, children with more severe clinical conditions may undergo invasive mechanical ventilation (IMV). However, its prolonged use favors tracheal injury, barotrauma and / or volutrauma, decreased cardiac output and oxygen toxicity, and especially the accumulation of respiratory secretions due to ineffective cough due to non-closure of the glottis and damage in the transport of mucus by the presence of the tracheal tube. Thus, triggering the development of mechanical ventilation-associated pneumonia (VAP), which is defined as a pulmonary infection that arises 48 to 72 hours after endotracheal intubation and the institution of invasive mechanical ventilation. As a consequence, respiratory work is performed by IMV, reducing the work exerted by spontaneous ventilation, causing neuromuscular disorders after 5 to 7 days of IMV, changes in muscle mechanics, reducing the capacity of the diaphragm to generate force, thus contributing to changes in modulation autonomic heart rate, changes in muscular trophism, generating physical deconditioning due to weakness and, finally, an increase in the length of hospitalization and immobilism. From this perspective, early mobilization emerges as a rehabilitation mechanism to improve muscle strength and joint mobility, as well as to improve lung function and respiratory system performance, as well as improved autonomic heart rate modulation. It can facilitate the weaning of IMV, reducing hospitalization time and promoting quality of life after discharge.
Read the detailed description
We will select 40 volunteers of both sexes and between the ages of 1 and 8 years, with clinical diagnosis of VAP hospitalized in an intensive care unit, which will be submitted, together with the hospital protocol, the protocol of early mobilization. For these patients will be performed physical therapy evaluation in the pre-protocol period, on the second and fourth day of application of the protocol and 1 week at the end of the proposed protocol. For statistical analysis will be compared the pre and post-treatment data found in the evaluations and tabulated in a Microsoft Excel worksheet. BioStat 5.2 software will be used to analyze the results, and the choice of tests for this will depend on the types of distributions found and the homogeneity of the variables.
- Conditions
- Pneumonia
- Being tested
- Rehabilitation, Chest physical therapy
- Keywords
- Pneumonia, Ventilator-Associated, Mechanical ventilation, Physical therapy
- Medical subject headings
- Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Also called physical therapy
physical therapy exercise
Chest physical therapyOther
chest physical therapy exercise
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation | Experimental | Phase 1 passive mobilization with 10 repetitions on each joint motion and muscle stretching to the upper.
Phase 2 - ability to respond to 3 of 5 simple verbal commands. Beginning with passive, active-assisted or active exercises with 5 repetitions in each joint movement in the MMSS and MMII, following the sequence of phase 1.
Phase 3 - exercises of MMSS with cycle ergometer - 1 series of 1 minute or passive, active-assisted, active or active-resistidos with 5 repetitions in each joint movement, following the sequence of phase 1. Receives: Other: Rehabilitation |
| chest physical therapy | Active comparator | respiratory exercises that include techniques of bronchial hygiene maneuvers with the objective of airway clearance, pulmonary reexpansion techniques for reversal of atelectasis, passive mobilization techniques with the aim of reducing deformities and preserving joint mobility Receives: Other: Chest physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Influence of exercise on cardiac autonomic modulation
Measured: 5 days
Secondary outcomes (1)
Muscle force
Analysis by Medical Research Council Scale of muscle force. The scale is classified in five grades Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.
Grade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side.
Grade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.
Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.
Grade 0: No movement is observed.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Responsible party
- Principal investigator, Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba
- Investigators
- Rodrigo S Rocha, Doctor, Principal investigator, Universidade do Estado do Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343717
- Sponsor's protocol ID
- 2.084.580
- Acronym
- VAP
- Status last verified
- Aug 2020
- First submitted
- 12 Nov 2017
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choong K, Koo KK, Clark H, Chu R, Thabane L, Burns KE, Cook DJ, Herridge MS, Meade MO. Early mobilization in critically ill children: a survey of Canadian practice. Crit Care Med. 2013 Jul;41(7):1745-53. doi: 10.1097/CCM.0b013e318287f592.
PubMed 23507722Choong K, Foster G, Fraser DD, Hutchison JS, Joffe AR, Jouvet PA, Menon K, Pullenayegum E, Ward RE; Canadian Critical Care Trials Group. Acute rehabilitation practices in critically ill children: a multicenter study. Pediatr Crit Care Med. 2014 Jul;15(6):e270-9. doi: 10.1097/PCC.0000000000000160.
PubMed 24777303Choong K. Early Mobilization in Critically Ill Children: Ready for Implementation? Pediatr Crit Care Med. 2016 Dec;17(12):1194-1195. doi: 10.1097/PCC.0000000000000992. No abstract available.
PubMed 27918395Souza GSB, Novais MFM, Lemes GE, de Mello MLFMF, de Sales SCD, Cunha KDC, Rocha LSO, Avila PES, Rocha RSB. Effectiveness of Different Physiotherapy Protocols in Children in the Intensive Care Unit: A Randomized Clinical Trial. Pediatr Phys Ther. 2022 Jan 1;34(1):10-15. doi: 10.1097/PEP.0000000000000848.
PubMed 34873117
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Mobilization in Children With Pneumonia
- ClinicalTrials.gov ID
- NCT03343717
- Acronym / sponsor ID
- VAP / 2.084.580
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Ventilator-Associated, Mechanical ventilation, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
The children's susceptibility to respiratory problems is due to their anatomical and physiological characteristics; therefore, children with more severe clinical conditions may undergo invasive mechanical ventilation (IMV). However, its prolonged use favors tracheal injury, barotrauma and / or volutrauma, decreased cardiac output and oxygen toxicity, and especially the accumulation of respiratory secretions due to ineffective cough due to non-closure of the glottis and damage in the transport of mucus by the presence of the tracheal tube. Thus, triggering the development of mechanical ventilation-associated pneumonia (VAP), which is defined as a pulmonary infection that arises 48 to 72 hours after endotracheal intubation and the institution of invasive mechanical ventilation. As a consequence, respiratory work is performed by IMV, reducing the work exerted by spontaneous ventilation, causing neuromuscular disorders after 5 to 7 days of IMV, changes in muscle mechanics, reducing the capacity of the diaphragm to generate force, thus contributing to changes in modulation autonomic heart rate, changes in muscular trophism, generating physical deconditioning due to weakness and, finally, an increase in the length of hospitalization and immobilism. From this perspective, early mobilization emerges as a rehabilitation mechanism to improve muscle strength and joint mobility, as well as to improve lung function and respiratory system performance, as well as improved autonomic heart rate modulation. It can facilitate the weaning of IMV, reducing hospitalization time and promoting quality of life after discharge.
Detailed description
We will select 40 volunteers of both sexes and between the ages of 1 and 8 years, with clinical diagnosis of VAP hospitalized in an intensive care unit, which will be submitted, together with the hospital protocol, the protocol of early mobilization. For these patients will be performed physical therapy evaluation in the pre-protocol period, on the second and fourth day of application of the protocol and 1 week at the end of the proposed protocol. For statistical analysis will be compared the pre and post-treatment data found in the evaluations and tabulated in a Microsoft Excel worksheet. BioStat 5.2 software will be used to analyze the results, and the choice of tests for this will depend on the types of distributions found and the homogeneity of the variables.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| rehabilitation | Experimental | Other: RehabilitationPhase 1 passive mobilization with 10 repetitions on each joint motion and muscle stretching to the upper. Phase 2 - ability to respond to 3 of 5 simple verbal commands. Beginning with passive, active-assisted or active exercises with 5 repetitions in each joint movement in the MMSS and MMII, following the sequence of phase 1. Phase 3 - exercises of MMSS with cycle ergometer - 1 series of 1 minute or passive, active-assisted, active or active-resistidos with 5 repetitions in each joint movement, following the sequence of phase 1. |
| chest physical therapy | Active comparator | Other: Chest physical therapyrespiratory exercises that include techniques of bronchial hygiene maneuvers with the objective of airway clearance, pulmonary reexpansion techniques for reversal of atelectasis, passive mobilization techniques with the aim of reducing deformities and preserving joint mobility |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients on invasive or non-invasive mechanical ventilation for less than 96 hours
- with pneumonia due to invasive mechanical ventilation,
- aged between 1 year and 8 years
Key exclusion criteria (6 listed)
- Severe Respiratory Failure
- active bleeding
- acute cerebral disorder
- presence of orthopedic contraindications (bone fractures, dislocations, subluxations, postoperative, unstable spine)
- neurological impairment with minimal functionality
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 |
|---|---|---|
| RehabilitationAlso: physical therapyphysical therapy exercise | Other | rehabilitation |
| Chest physical therapychest physical therapy exercise | Other | chest physical therapy |
Primary outcome
Heart rate variability
Time frame: 5 days
Influence of exercise on cardiac autonomic modulation
1 secondary outcome
Muscle force
Time frame: 5 days
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 13 Aug 2020.
- Results publication: PubMed 23507722Choong K, Koo KK, Clark H, Chu R, Thabane L, Burns KE, Cook DJ, Herridge MS, Meade MO. Early mobilization in critically ill children: a survey of Canadian practice. Crit Care Med. 2013 Jul;41(7):1745-53. doi: 10.1097/CCM.0b013e318287f592.
- Results publication: PubMed 24777303Choong K, Foster G, Fraser DD, Hutchison JS, Joffe AR, Jouvet PA, Menon K, Pullenayegum E, Ward RE; Canadian Critical Care Trials Group. Acute rehabilitation practices in critically ill children: a multicenter study. Pediatr Crit Care Med. 2014 Jul;15(6):e270-9. doi: 10.1097/PCC.0000000000000160.
- Results publication: PubMed 27918395Choong K. Early Mobilization in Critically Ill Children: Ready for Implementation? Pediatr Crit Care Med. 2016 Dec;17(12):1194-1195. doi: 10.1097/PCC.0000000000000992. No abstract available.
- Derived from this study: PubMed 34873117Souza GSB, Novais MFM, Lemes GE, de Mello MLFMF, de Sales SCD, Cunha KDC, Rocha LSO, Avila PES, Rocha RSB. Effectiveness of Different Physiotherapy Protocols in Children in the Intensive Care Unit: A Randomized Clinical Trial. Pediatr Phys Ther. 2022 Jan 1;34(1):10-15. doi: 10.1097/PEP.0000000000000848.
- Individual participant dataSharing planned: No
Related trials for Pneumonia
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
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.
Rodrigo S Rocha, Doctor principal investigator
Universidade do Estado do Pará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation and Chest physical therapy in people with Pneumonia, run by Universidade Metodista de Piracicaba 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 3 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 13 Aug 2020. 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.
What does the primary outcome measure?
Heart rate variability (time frame: 5 days). 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 NCT03343717, 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 13 Aug 2020.