NCT02047383

Brief Summary

The acute respiratory infection is the fourth most common cause of hospital stay between elderly people. The purpose of this study is to evaluate the repercussion of hospital stay in hospitalized patients with a respiratory infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

January 22, 2014

Last Update Submit

November 2, 2016

Conditions

Keywords

respiratory infectionphysical variables

Outcome Measures

Primary Outcomes (1)

  • Strength in upper and lower limbs

    The quadriceps and the hand-grip strength is assessed using a dynamometer with a standard protocol allowing three attempts on each side. During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°. The maximum value achieved was used in the analyses. This is important in order to quantify the increase of strength Kg/cm2 The test 2-minute step in place is also going to be used for this purpose, counting the times the patients go up the right knees in two minutes.

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

Secondary Outcomes (5)

  • Quality of life

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

  • Lung function

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

  • Activity monitoring

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

  • Quality of sleep

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

  • Mood

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

Study Arms (1)

respiratory infection

Hospitalized patients with a respiratory infection

Other: Respiratory infection

Interventions

An assessment of the patients included in the study will be conducted

Also known as: Descriptive
respiratory infection

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients with an acute respiratory infection

You may qualify if:

  • Diagnosis of respiratory infection
  • Age: more than 50 year.
  • Signed written consent.

You may not qualify if:

  • Heart disease and concomitant neurological condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of health Sciences. University of Granada

Granada, Spain, 18071, Spain

Location

Related Publications (1)

  • Martin-Salvador A, Torres-Sanchez I, Saez-Roca G, Lopez-Torres I, Rodriguez-Alzueta E, Valenza MC. Age group analysis of psychological, physical and functional deterioration in patients hospitalized for pneumonia. Arch Bronconeumol. 2015 Oct;51(10):496-501. doi: 10.1016/j.arbres.2014.11.009. Epub 2015 Jan 17. English, Spanish.

    PMID: 25605525BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Cold Temperature

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 28, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations