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
About this trial
This is an interventional treatment trial for Pneumonia
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
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
NCT ID
NCT02103400
First Posted
March 22, 2014
Last Updated
March 30, 2016
Sponsor
University of Nove de Julho
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
Learn more about this trial
Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia
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