PneumoniaEPICCNCT01744145
Effect of Exercise and Education After Pneumonia
A study testing Interventional 40-60 and Interventional 60 and above in people with Pneumonia, run by Winthrop University Hospital at 1 site in United States.
Trial summary
The mortality rate and quality of life is effected in patients with pneumonia, especially in the older population. The end point of this study is to improve quality of life by and interventional exercise and education. Patients will be randomized at admission and enrolled into the study. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- Interventional 40-60 and Interventional 60 and above
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2016
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of CAP or HCAP via radiographic imaging and symptoms of pneumonia Age 40 and above.
- Discharge to home.
- Ability to read and sign consent.
- Ability to perform in procedures/exercise.
- Ability to understand educational component of the program.
- Antibiotic administration for pneumonia within 12 hours of admission.
Who cannot join
- Severe lung diseases like ILD(Interstitial Lung disease), ARDS (Adult Respiratory Distress Syndrome.)
- Ventilator dependent patients.
- Discharge to nursing home.
- Comorbidity that could limit exercise training.
- Dementia, Schizophrenia or any active severe psychiatric disorder.
- Any Active Malignancy or diagnosis of Lung malignancy.
Show all 10Show fewer
- Inability to attend program two times per week.
- Recent myocardial infarction within two months.
- Unstable angina, Heart failure (NYHA class III and IV.)
- Patients with pneumonia who did not receive antibiotics within 12 hours of admission.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hosptial
Mineola, New York, 11501
About this study
Official title: Early Pneumonia Intervention to Prevent Chronic Complications in Patients Age 40 and Above
The mortality rate and quality of life is effected in patients with pneumonia, especially in the older population.
The end point of this study is to improve quality of life by and interventional exercise and education. Patients will be randomized at admission and enrolled into the study. They will be assessed with various performance and quality of life indicators before, during and after the study, and exercise tolerance will be assessed throughout and after.
Read the detailed description
The purpose of this research study is to assess improvement in functional status and quality of life of patients 40 years of age and older patients hospitalized for community acquired pneumonia and healthcare associated pneumonia with a multi-disciplinary program of exercise, education and psychological support. This study will use a randomized, controlled clinical trial design. The total number of patients enrolled will be 120, divided into two groups of 60 patients each. One group will have patients age 40 to 60 and second group will have patients age 60 and above. Stratified randomization will be done to divide these into two (control group and intervention group) equal groups with 30 patients each. The primary endpoint is improvement in quality of life indices. Secondary endpoints are improvement in functional status, change in 6 minute walk test, exercise intolerance, immunization, occult desaturation and change in body weight of patients hospitalized for community acquired pneumonia with a multi-disciplinary program of exercise, education and, psychological support. Eligibility includes age 40 and above at the time of admission, diagnosis of CAP and HCAP via radiographic and PNA symptoms, discharge to home, ability to read and sign informed consent to participate, ability to perform procedures/exercises involved in the study and ability to comprehend educational component of program.
- Conditions
- Pneumonia
- Being tested
- Interventional 40-60, Interventional 60 and above
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional 40-60Other
This group will receive the intervention aged 40-60
Interventional 60 and aboveOther
This group will receive the intervention aged 60 and above.
| Study group | Role | What they receive |
|---|---|---|
| Interventional 40-60 | Active comparator | Interventional group aged 40-60 Receives: Other: Interventional 40-60 |
| Control 40-60 | No intervention | Control group aged 40-60 |
| Interventional 60 and above | Active comparator | Interventional group aged 60 and above Receives: Other: Interventional 60 and above |
| Control 60 and above | No intervention | Control group aged 60 and above |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in quality of life indices
patients in the interventional group will undergo exercise and education after a pneumonia infection to see if the quality of life is effected by a rehab program
Measured: one year
Secondary outcomes (4)
improvement in functional status
Measured: one year
change in 6 minute walk test
Measured: one year
exercise intolerance
Measured: one year
immunization
Patients will be assessed to see if education offered in the interventional group will effect compliance with vaccination.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: not enough enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shalinee Chawla, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744145
- Sponsor's protocol ID
- 255021-4
- Acronym
- EPICC
- Status last verified
- Jan 2016
- First submitted
- 20 Sep 2012
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pneumonia Intervention to Prevent Chronic Complications in Patients Age 40 and Above
- ClinicalTrials.gov ID
- NCT01744145
- Acronym / sponsor ID
- EPICC / 255021-4
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Dec 2012 (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.
The mortality rate and quality of life is effected in patients with pneumonia, especially in the older population.
The end point of this study is to improve quality of life by and interventional exercise and education. Patients will be randomized at admission and enrolled into the study. They will be assessed with various performance and quality of life indicators before, during and after the study, and exercise tolerance will be assessed throughout and after.
Detailed description
The purpose of this research study is to assess improvement in functional status and quality of life of patients 40 years of age and older patients hospitalized for community acquired pneumonia and healthcare associated pneumonia with a multi-disciplinary program of exercise, education and psychological support. This study will use a randomized, controlled clinical trial design. The total number of patients enrolled will be 120, divided into two groups of 60 patients each. One group will have patients age 40 to 60 and second group will have patients age 60 and above. Stratified randomization will be done to divide these into two (control group and intervention group) equal groups with 30 patients each. The primary endpoint is improvement in quality of life indices. Secondary endpoints are improvement in functional status, change in 6 minute walk test, exercise intolerance, immunization, occult desaturation and change in body weight of patients hospitalized for community acquired pneumonia with a multi-disciplinary program of exercise, education and, psychological support. Eligibility includes age 40 and above at the time of admission, diagnosis of CAP and HCAP via radiographic and PNA symptoms, discharge to home, ability to read and sign informed consent to participate, ability to perform procedures/exercises involved in the study and ability to comprehend educational component of program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Interventional 40-60 | Active comparator | Other: Interventional 40-60Interventional group aged 40-60 |
| Control 40-60 | No intervention | –Control group aged 40-60 |
| Interventional 60 and above | Active comparator | Other: Interventional 60 and aboveInterventional group aged 60 and above |
| Control 60 and above | No intervention | –Control group aged 60 and above |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of CAP or HCAP via radiographic imaging and symptoms of pneumonia Age 40 and above.
- Discharge to home.
- Ability to read and sign consent.
- Ability to perform in procedures/exercise.
- Ability to understand educational component of the program.
Key exclusion criteria (10 listed)
- Severe lung diseases like ILD(Interstitial Lung disease), ARDS (Adult Respiratory Distress Syndrome.)
- Ventilator dependent patients.
- Discharge to nursing home.
- Comorbidity that could limit exercise training.
- Dementia, Schizophrenia or any active severe psychiatric disorder.
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 |
|---|---|---|
| Interventional 40-60This group will receive the intervention aged 40-60 | Other | Interventional 40-60 |
| Interventional 60 and aboveThis group will receive the intervention aged 60 and above. | Other | Interventional 60 and above |
Primary outcome
improvement in quality of life indices
Time frame: one year
patients in the interventional group will undergo exercise and education after a pneumonia infection to see if the quality of life is effected by a rehab program
4 secondary outcomes
improvement in functional status
Time frame: one year
change in 6 minute walk test
Time frame: one year
exercise intolerance
Time frame: one year
immunization
Time frame: one year
Results and safety
The study was stopped early (reason given: not enough enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
Shalinee Chawla, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional 40-60 and Interventional 60 and above in people with Pneumonia, run by Winthrop University Hospital at 1 site in United States.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 Apr 2023. 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 United States. 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?
The study was stopped early (reason given: not enough enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in quality of life indices (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.