PneumoniaNCT02515565
Physiotherapy in Patients Hospitalized Due to Pneumonia.
A study testing cephalosporin with or without erythromycin and Physiotherapy program in people with Pneumonia, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- cephalosporin with or without erythromycin and Physiotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of pneumonia.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion.
Who cannot join
- Contraindications of physiotherapy.
- Neurological, orthopedic or heart disease.
- Prosthetic devices in lower limbs.
Trial locations and contacts
1 site in 1 country.
Marie Carmen Valenza, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences. University of Granada.
Granada, 18071
M. Carmen, Ph, MD, 958 248035
M. Carmen Valenza, Ph, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- cephalosporin with or without erythromycin, Physiotherapy program
- Keywords
- pneumonia, Exacerbation, physiotherapy, hospitalization
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalosporin with or without erythromycinDrug
Also called Standard medical treatment
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.
Physiotherapy programOther
Also called Physiotherapy, Electrostimulation, Respiratory exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: Physiotherapy program |
| Control group | Other | 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. Receives: Drug: cephalosporin with or without erythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Quadriceps strength will be assessed with a portable dynamometer. The test will be performed as previously reported.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary outcomes (6)
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Dyspnea perception
Dyspnea perception will be assessed with Borg modified scale. Patients will classify their breathlessness between 0 and 10.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
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).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Mood
Mood in these patients will be measured by the Hospital Anxiety and Depression Scale.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2018
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515565
- Sponsor's protocol ID
- DF0057UG
- Status last verified
- Jul 2018
- First submitted
- 2 Aug 2015
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31244327
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physiotherapy Program in Patients Hospitalized Due to Pneumonia
- ClinicalTrials.gov ID
- NCT02515565
- Acronym / sponsor ID
- DF0057UG
- Conditions
- Pneumonia
- Keywords
- pneumonia, Exacerbation, physiotherapy, hospitalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jul 2018 (estimated)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Physiotherapy programPatients 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. |
| Control group | Other | Drug: cephalosporin with or without erythromycinPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Diagnosis of pneumonia.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion.
Key exclusion criteria (3 listed)
- Contraindications of physiotherapy.
- Neurological, orthopedic or heart disease.
- Prosthetic devices in lower limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cephalosporin with or without erythromycinAlso: Standard medical treatmentSecond- 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. | Drug | Control group |
| Physiotherapy programAlso: Physiotherapy, Electrostimulation, Respiratory exercisesThe 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 | Experimental group |
Primary outcome
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.
6 secondary outcomes
Respiratory function
Time frame: 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
Quality of life
Time frame: 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.
Fatigue
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Derived from this study: PubMed 31244327Lopez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Carmen Valenza, PhD contact
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cephalosporin with or without erythromycin and Physiotherapy program in people with Pneumonia, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD (958 248035, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.