Physiotherapy in Patients Hospitalized Due to Pneumonia.

Overview

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.

Full Title of Study: “Effects of a Physiotherapy Program in Patients Hospitalized Due to Pneumonia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: April 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad de Granada
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marie Carmen Valenza, PhD – Universidad de Granada
  • Overall Official(s)
    • Marie Carmen Valenza, PhD, Principal Investigator, Universidad de Granada
  • Overall Contact(s)
    • Marie Carmen Valenza, PhD, 958 248035, cvalenza@ugr.es

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