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Physiotherapy on Pneumonia in Childrens (VAP)

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rehabilitation
Chest physical therapy
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pneumonia focused on measuring Pneumonia, Ventilator-Associated, Mechanical ventilation, Physical therapy

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Fundação Santa Casa de Misericórdia do Pará

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rehabilitation

chest physical therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Heart rate variability
Influence of exercise on cardiac autonomic modulation

Secondary Outcome Measures

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.

Full Information

First Posted
November 12, 2017
Last Updated
August 11, 2020
Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará
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1. Study Identification

Unique Protocol Identification Number
NCT03343717
Brief Title
Physiotherapy on Pneumonia in Childrens
Acronym
VAP
Official Title
Effects of Early Mobilization in Children With Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Pneumonia, Ventilator-Associated, Mechanical ventilation, Physical therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
chest physical therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Other Intervention Name(s)
physical therapy
Intervention Description
physical therapy exercise
Intervention Type
Other
Intervention Name(s)
Chest physical therapy
Intervention Description
chest physical therapy exercise
Primary Outcome Measure Information:
Title
Heart rate variability
Description
Influence of exercise on cardiac autonomic modulation
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Muscle force
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
1 year to 8 years
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo S Rocha, Doctor
Organizational Affiliation
Universidade do Estado do Pará
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundação Santa Casa de Misericórdia do Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66.050-380
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23507722
Citation
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.
Results Reference
result
PubMed Identifier
24777303
Citation
Choong 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 Reference
result
PubMed Identifier
27918395
Citation
Choong 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.
Results Reference
result
PubMed Identifier
34873117
Citation
Souza 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.
Results Reference
derived

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Physiotherapy on Pneumonia in Childrens

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