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Effect of Exercise and Education After Pneumonia (EPICC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01744145
Recruitment Status : Unknown
Verified December 2012 by Shalinee Chawla, MD, Winthrop University Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.


Condition or disease Intervention/treatment
Pneumonia Other: Interventional 40-60 Other: Interventional 60 and above

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Pneumonia Intervention to Prevent Chronic Complications in Patients Age 40 and Above
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Interventional 40-60
Interventional group aged 40-60
Other: Interventional 40-60
This group will receive the intervention aged 40-60
Placebo Comparator: Control 40-60
Control group aged 40-60
Active Comparator: Interventional 60 and above
Interventional group aged 60 and above
Other: Interventional 60 and above
This group will receive the intervention aged 60 and above.
Placebo Comparator: Control 60 and above
Control group aged 60 and above


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. improvement in functional status [ Time Frame: one year ]
  2. change in 6 minute walk test [ Time Frame: one year ]
  3. exercise intolerance [ Time Frame: one year ]
  4. immunization [ Time Frame: one year ]
    Patients will be assessed to see if education offered in the interventional group will effect compliance with vaccination.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnosis of CAP or HCAP via radiographic imaging and symptoms of pneumonia Age 40 and above.
  2. Discharge to home.
  3. Ability to read and sign consent.
  4. Ability to perform in procedures/exercise.
  5. Ability to understand educational component of the program.
  6. Antibiotic administration for pneumonia within 12 hours of admission.

Exclusion Criteria:

  1. Severe lung diseases like ILD(Interstitial Lung disease), ARDS (Adult Respiratory Distress Syndrome.)
  2. Ventilator dependent patients.
  3. Discharge to nursing home.
  4. Comorbidity that could limit exercise training.
  5. Dementia, Schizophrenia or any active severe psychiatric disorder.
  6. Any Active Malignancy or diagnosis of Lung malignancy.
  7. Inability to attend program two times per week.
  8. Recent myocardial infarction within two months.
  9. Unstable angina, Heart failure (NYHA class III and IV.)
  10. Patients with pneumonia who did not receive antibiotics within 12 hours of admission.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744145


Contacts
Contact: Abid I Khokar, MD 516-663-2004 ext 2004 akhokar@winthrop.org
Contact: Shalinee Chawla, MD 516-663-2004 ext 2004 schawla@winthrop.org

Locations
United States, New York
Winthrop University Hosptial Recruiting
Mineola, New York, United States, 11501
Sub-Investigator: Abid Khokar, MD         
Sub-Investigator: Peter Spiegler, MD         
Sub-Investigator: Grace Trimmer, MD         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Shalinee Chawla, MD Winthrop University Hospital
More Information

Responsible Party: Shalinee Chawla, MD, Principal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01744145     History of Changes
Other Study ID Numbers: 255021-4
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections