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Trial record 59 of 182 for:    ERYTHROMYCIN

Physiotherapy in Patients Hospitalized Due to Pneumonia.

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ClinicalTrials.gov Identifier: NCT02515565
Recruitment Status : Recruiting
First Posted : August 4, 2015
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Tracking Information
First Submitted Date  ICMJE August 2, 2015
First Posted Date  ICMJE August 4, 2015
Last Update Posted Date July 12, 2018
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02515565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 3, 2015)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Physiotherapy in Patients Hospitalized Due to Pneumonia.
Official Title  ICMJE Effects of a Physiotherapy Program in Patients Hospitalized Due to Pneumonia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • 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 Name: 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
    • Electrostimulation
    • Respiratory exercises
Study Arms  ICMJE
  • 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.
    Intervention: Other: Physiotherapy program
  • 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.
    Intervention: Drug: cephalosporin with or without erythromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Carmen Valenza, PhD 958 248035 cvalenza@ugr.es
Contact: Marie Carmen Valenza, PhD cvalenza@ugr.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02515565
Other Study ID Numbers  ICMJE DF0057UG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marie Carmen Valenza, Universidad de Granada
Study Sponsor  ICMJE Universidad de Granada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada
PRS Account Universidad de Granada
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP