Physiotherapy in Patients Hospitalized Due to Pneumonia.

July 11, 2018 updated by: Marie Carmen Valenza, Universidad de Granada

Effects of a Physiotherapy Program in Patients Hospitalized Due to Pneumonia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Recruiting
        • Faculty of Health Sciences. University of Granada.
        • Contact:
          • M. Carmen, Ph, MD
          • Phone Number: 958 248035
        • Principal Investigator:
          • M. Carmen Valenza, Ph, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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
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.
Other Names:
  • Physiotherapy
  • Respiratory exercises
  • Electrostimulation
Other: Control group
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
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 Names:
  • Standard medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
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
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory function
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
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
Dyspnea perception
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
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
Quality of life
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
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.
Functionality
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
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.
Fatigue
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
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.
Mood
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dependency levels
Time Frame: Baseline
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
Comorbidities
Time Frame: Baseline
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
Nutritional status
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

August 2, 2015

First Submitted That Met QC Criteria

August 3, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF0057UG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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