Physiotherapy in Patients Hospitalized Due to Pneumonia.

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

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.

Condition or disease	Intervention/treatment	Phase
Pneumonia	Drug: cephalosporin with or without erythromycin; Other: Physiotherapy program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of a Physiotherapy Program in Patients Hospitalized Due to Pneumonia
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: April 2018
• Estimated Study Completion Date: July 2018

Arms and Interventions

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; Electrostimulation; Respiratory exercises
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 Name: Standard medical treatment

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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).
5. 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.
6. 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.

Other Outcome Measures:

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Marie Carmen Valenza, PhD; 958 248035; cvalenza@ugr.es

Contact: Marie Carmen Valenza, PhD; cvalenza@ugr.es

Locations

Spain

Faculty of Health Sciences. University of Granada.; Recruiting

Granada, Spain, 18071

Contact: M. Carmen , Ph, MD 958 248035

Principal Investigator: M. Carmen Valenza, Ph, MD

Sponsors and Collaborators

Universidad de Granada

Investigators

• Principal Investigator: Marie Carmen Valenza, PhD; Universidad de Granada

More Information

• Responsible Party: Marie Carmen Valenza, PhD, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT02515565 History of Changes
• Other Study ID Numbers: DF0057UG
• First Posted: August 4, 2015
• Last Update Posted: July 12, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Marie Carmen Valenza, Universidad de Granada:

pneumonia; Exacerbation; physiotherapy; hospitalization

Additional relevant MeSH terms:

Pneumonia; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Cephalosporins; Anti-Bacterial Agents; Anti-Infective Agents; Gastrointestinal Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action