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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02047383
Other study ID # DF0047UG
Secondary ID
Status Completed
Phase N/A
First received January 22, 2014
Last updated November 2, 2016
Start date January 2014
Est. completion date August 2014

Study information

Verified date November 2016
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Observational

Clinical Trial 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.


Description:

Acute respiratory infection is a serious infection that prevents normal breathing function. It refers to any of a number of infectious diseases involving the respiratory tract. Health conditions that increase the risk of a respiratory infection include: another lung condition, a heart condition, a kidney or liver condition and a lowered immune system. The hospital stay of this patients is approximately 7-10 days and it is important to study the effects of this stay in the physical and psycho-emotional characteristics of patients.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date August 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of respiratory infection

- Age: more than 50 year.

- Signed written consent.

Exclusion Criteria:

- Heart disease and concomitant neurological condition.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Other:
Respiratory infection
An assessment of the patients included in the study will be conducted

Locations

Country Name City State
Spain Faculty of health Sciences. University of Granada Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Martín-Salvador A, Torres-Sánchez I, Sáez-Roca G, López-Torres I, Rodríguez-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. English, Spanish. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Quality of life The quality of life associated with health is going to be measure with t the EuroQol-5 questionnaire. Participants will be followed for the duration of hospital stay, an expected average of 8 days Yes
Secondary Lung function Lung function is going to be evaluated using a spirometer. Participants will be followed for the duration of hospital stay, an expected average of 8 days Yes
Secondary Activity monitoring The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours. Participants will be followed for the duration of hospital stay, an expected average of 8 days Yes
Secondary Quality of sleep Changes in quality of sleep. For this purpose, the participants are going to complete the Pittsburgh Quality of Sleep Index. This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21. Participants will be followed for the duration of hospital stay, an expected average of 8 days Yes
Secondary Mood Mood in these patients will be measured by the Hospital Anxiety and Depression Scale. Participants will be followed for the duration of hospital stay, an expected average of 8 days Yes
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