NCT02515565

Brief Summary

Acute respiratory infections are the fourth cause of hospitalization in elderly. Various studies have examined the impact of hospitalization in patients with respiratory pathology, showing the need of interventions in order to reduce the impact of hospitalization. The objective of this study is to examine whether a physical therapy intervention can reduce impairment in patients hospitalized due to pneumonia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

August 2, 2015

Last Update Submit

July 11, 2018

Conditions

Keywords

pneumoniaExacerbationphysiotherapyhospitalization

Outcome Measures

Primary Outcomes (2)

  • Muscle strength

    Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported.

    Participants will be followed for the duration of hospital stay, an expected average of 8 days

  • Exercise capacity

    Five times sit to stand test (5STS) will be used to assess exercise capacity, 5STS is a simple assessment tool that is feasible in all healthcare settings, and may be a rapid method of assessing changes in exercise capacity in COPD and screening for poor physical functioning individuals.

    Participants will be followed for the duration of hospital stay, an expected average of 8 days

Secondary Outcomes (6)

  • Respiratory function

    Participants will be followed for the duration of hospital stay, an expected average of 8 days

  • Dyspnea perception

    Participants will be followed for the duration of hospital stay, an expected average of 8 days

  • Quality of life

    Participants will be followed for the duration of hospital stay, an expected average of 8 days.

  • Functionality

    Participants will be followed for the duration of hospital stay, an expected average of 8 days.

  • Fatigue

    Participants will be followed for the duration of hospital stay, an expected average of 8 days.

  • +1 more secondary outcomes

Other Outcomes (3)

  • Dependency levels

    Baseline

  • Comorbidities

    Baseline

  • Nutritional status

    Baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients with a clinical diagnosis of pneumonia will be included in this group. They will be included in a physiotherapy program added to the standard medical treatment.

Other: Physiotherapy program

Control group

OTHER

Patients with a clinical diagnosis of pneumonia will be included in this group. They will receive only the standard medical treatment based on cephalosporin with or without erythromycin.

Drug: cephalosporin with or without erythromycin

Interventions

Second- or third-generation cephalosporin (cefuroxime, cefotaxime, or ceftriaxone) with or without erythromycin, given parenterally; parenteral therapy should continue until the patient has been afebrile for more than 24 hours and oxygen saturation exceeds 95 percent.

Also known as: Standard medical treatment
Control group

The physiotherapy treatment will be performed during the hospitalization, every day during 45-60 minutes added to the standard medical treatment. I will include breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.

Also known as: Physiotherapy, Electrostimulation, Respiratory exercises
Experimental group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosis of pneumonia.
  • No contraindication of physiotherapy.
  • Signed written consent.

You may not qualify if:

  • Contraindications of physiotherapy.
  • Neurological, orthopedic or heart disease.
  • Prosthetic devices in lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, 18071, Spain

RECRUITING

Related Publications (1)

  • Lopez-Lopez L, Torres-Sanchez I, Rodriguez-Torres J, Cabrera-Martos I, Ortiz-Rubio A, Valenza MC. Does adding an integrated physical therapy and neuromuscular electrical stimulation therapy to standard rehabilitation improve functional outcome in elderly patients with pneumonia? A randomised controlled trial. Clin Rehabil. 2019 Nov;33(11):1757-1766. doi: 10.1177/0269215519859930. Epub 2019 Jun 27.

MeSH Terms

Conditions

Pneumonia

Interventions

CephalosporinsErythromycinPhysical Therapy ModalitiesTranscutaneous Electric Nerve StimulationBreathing Exercises

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

beta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesPolyketidesLactonesTherapeuticsRehabilitationElectric Stimulation TherapyAnalgesiaAnesthesia and AnalgesiaMind-Body TherapiesComplementary TherapiesExercise Movement Techniques

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Carmen Valenza, PhD

CONTACT

Marie Carmen Valenza, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 2, 2015

First Posted

August 4, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

July 12, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations