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Physiotherapy in Patients Hospitalized Due to Pneumonia.

Primary Purpose

Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
cephalosporin with or without erythromycin
Physiotherapy program
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring pneumonia, Exacerbation, physiotherapy, hospitalization

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Health Sciences. University of Granada.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Dyspnea perception
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
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.
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).
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.
Mood
Mood in these patients will be measured by the Hospital Anxiety and Depression Scale.

Full Information

First Posted
August 2, 2015
Last Updated
July 11, 2018
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT02515565
Brief Title
Physiotherapy in Patients Hospitalized Due to Pneumonia.
Official Title
Effects of a Physiotherapy Program in Patients Hospitalized Due to Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
pneumonia, Exacerbation, physiotherapy, hospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cephalosporin with or without erythromycin
Other Intervention Name(s)
Standard medical treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy program
Other Intervention Name(s)
Physiotherapy, Electrostimulation, Respiratory exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle strength
Description
Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Title
Exercise capacity
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary Outcome Measure Information:
Title
Respiratory function
Description
Spirometry is regarded as the gold standard measure of respiratory function. Spirometry will be performed according to the American Thoracic Society (ATS) criteria.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Title
Dyspnea perception
Description
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Title
Quality of life
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Title
Functionality
Description
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).
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Title
Fatigue
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Title
Mood
Description
Mood in these patients will be measured by the Hospital Anxiety and Depression Scale.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Other Pre-specified Outcome Measures:
Title
Dependency levels
Description
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.
Time Frame
Baseline
Title
Comorbidities
Description
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.
Time Frame
Baseline
Title
Nutritional status
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Phone
958 248035
Email
cvalenza@ugr.es
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Email
cvalenza@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada.
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Carmen, Ph, MD
Phone
958 248035
First Name & Middle Initial & Last Name & Degree
M. Carmen Valenza, Ph, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31244327
Citation
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.
Results Reference
derived

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Physiotherapy in Patients Hospitalized Due to Pneumonia.

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