Physiotherapy in Patients Hospitalized Due to Pneumonia.

Pneumonia Clinical Trial

Official title:

Effects of a Physiotherapy Program in Patients Hospitalized Due to Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02515565
• Other study ID #: DF0057UG
• Status: Recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Universidad de Granada
• Contact: Marie Carmen Valenza, PhD
• Phone: 958 248035
• Email: cvalenza[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Acute respiratory infections are the fourth cause of hospitalization in elderly. Hospital admissions due to pneumonia range from the 1.1 and 4 per 1,000 patients, increasing with age. Hospitalization causes a decline in physical and functional status. Physical impairment involves a higher risk of disability and mortality in elderly people. Various studies have examined the impact of hospitalization in patients with respiratory pathology, and it has been shown that hospitalization implies a significant physical impairment in patients admitted for pneumonia showing that this deterioration increases with age. That highlights 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of pneumonia.

• No contraindication of physiotherapy.

• Signed written consent.

• Medical approval for inclusion.

Exclusion Criteria:

• Contraindications of physiotherapy.

• Neurological, orthopedic or heart disease.

• Prosthetic devices in lower limbs.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• cephalosporin with or without erythromycin
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.

Other:
• Physiotherapy program
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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dependency levels	Dependency levels will be evaluated with the Functional Independence Measure (FIM). It is an 18-item, 7-level scale developed to uniformly assess severity of patient disability and medical rehabilitation functional outcome.	Baseline
Other	Comorbidities	Charlson Comorbidity Index will be used to assess the comorbidities of the patients, it is a simple and valid method of estimating risk of death from comorbid disease. It contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned with a score of 1, 2, 3 or 6 depending on the risk of dying associated with this condition.	Baseline
Other	Nutritional status	Nutritional status was evaluated with Mini nutritional assessment (MNA) test, that is validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. The MNA test is composed of simple measurements and brief questions that can be completed in about 10 min.	Baseline
Primary	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
Primary	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	Respiratory function	Spirometry is regarded as the gold standard measure of respiratory function. Spirometry will be performed according to the American Thoracic Society (ATS) criteria.	Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary	Dyspnea perception	Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.	Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary	Quality of life	EuroQol-5D (EQ-5D) will be used to assess quality of life. EQ-5D is a generic questionnaire and consists of two parts, the EQ-5D Visual analogue scale (VAS) and the EQ-5D index. The EQ-5D VAS consists on a vertical rating scale from 0 to 100 (0 = death/worst possible health state and 100 = best possible health state). The EQ-5D index is a five-item questionnaire (mobility, self-care, usual activity, pain/discomfort and anxiety/depression). Each item has three levels: no problem, some problem and severe problem.	Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Secondary	Functionality	The London Chest Activity of Daily Living (LCADL) is a valid tool that is validated to measure breathlessness during daily activities. It is a 15-item questionnaire divided in 4 domains: self-care (4 items), domestic (6 items) physical activity (2 items) and leisure (3 items).	Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Secondary	Fatigue	Fatigue will be assessed with the Fatigue Severity Scale (FSS). The FSS is a nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them.	Participants will be followed for the duration of hospital stay, an expected average of 8 days.
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.