NCT02103400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

March 22, 2014

Last Update Submit

March 30, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glittre test

    up to 9 months

Secondary Outcomes (1)

  • Shuttle test

    up to 9 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients hospitalized for community-acquired pneumonia

Other: Experimental group

Control group

ACTIVE COMPARATOR

Patients hospitalized for community-acquired pneumonia

Other: Control group

Interventions

Exercise Training Group

Also known as: -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)
Experimental group

Exercise control group

Also known as: -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
Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pneumonia

Interventions

WalkingControl GroupsBreathing Exercises

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor ActivityEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Simone Dal Corso, PhD

    University of Nove de Julho

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 22, 2014

First Posted

April 3, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations