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Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of pneumonia
  • Must be able to walk
  • Time less than 48 hours of hospitalization
  • Age above 18 years
  • Conscious and oriented
  • Hemodynamically stable

Exclusion Criteria:

  • Patients with other respiratory diseases
  • Osteoarticular or cognitive disorders
  • Patients who refuse to participate or complete the procedures

Sites / Locations

  • Universidade Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Patients hospitalized for community-acquired pneumonia

Patients hospitalized for community-acquired pneumonia

Outcomes

Primary Outcome Measures

Glittre test

Secondary Outcome Measures

Shuttle test

Full Information

First Posted
March 22, 2014
Last Updated
March 30, 2016
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02103400
Brief Title
Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia
Official Title
Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional capacity, peripheral muscle strength and quality of life. Despite the high incidence and severity has not yet been demonstrated whether a physical training program can change these outcomes. Objectives: To evaluate the effects of an exercise training program in patients hospitalized for CAP, to compare this effects with traditional physical therapy and assess whether the inflammatory markers correlate with the functional status of the patient and type of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk test, Glittre test, measurement of peripheral muscle strength, spirometry, and the application of quality of life questionnaire Shor Form 36 will be held. The measurement of inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held. Patients will be randomized into two groups: one will perform a program of physical training (stretching, active resistance exercises and aerobic exercises) and the other group held the traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight days. On the tenth day the same assessment will be carried out initially described.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients hospitalized for community-acquired pneumonia
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients hospitalized for community-acquired pneumonia
Intervention Type
Other
Intervention Name(s)
Experimental group
Other Intervention Name(s)
-heating: exercise of free movement of upper and lower limbs, -stretching: stretching various muscle groups, -cardio training walk: 15 minute walk with a high speed, -peripheral muscle strength: exercises using Theraband (R)
Intervention Description
Exercise Training Group
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
-chest percussion: manual chest percussion, -vibrocompression: manual therapy to the chest, -cough: request for coughing, -breathing exercises: exercises for lung expansion, -Walk: 15 minutes of light walking
Intervention Description
Exercise control group
Primary Outcome Measure Information:
Title
Glittre test
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Shuttle test
Time Frame
up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of pneumonia Must be able to walk Time less than 48 hours of hospitalization Age above 18 years Conscious and oriented Hemodynamically stable Exclusion Criteria: Patients with other respiratory diseases Osteoarticular or cognitive disorders Patients who refuse to participate or complete the procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Dal Corso, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Nove de Julho
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26996093
Citation
Jose A, Dal Corso S. Inpatient rehabilitation improves functional capacity, peripheral muscle strength and quality of life in patients with community-acquired pneumonia: a randomised trial. J Physiother. 2016 Apr;62(2):96-102. doi: 10.1016/j.jphys.2016.02.014. Epub 2016 Mar 17.
Results Reference
derived

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Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia

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