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Effect of Exercise and Education After Pneumonia (EPICC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Winthrop University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Shalinee Chawla, MD, Winthrop University Hospital Identifier:
First received: September 20, 2012
Last updated: December 4, 2012
Last verified: December 2012

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 Intervention
Other: Interventional 40-60
Other: Interventional 60 and above

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early Pneumonia Intervention to Prevent Chronic Complications in Patients Age 40 and Above

Resource links provided by NLM:

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 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:
  • 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 ]
    Patients will be assessed to see if education offered in the interventional group will effect compliance with vaccination.

Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
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Please refer to this study by its identifier: NCT01744145

Contact: Abid I Khokar, MD 516-663-2004 ext 2004
Contact: Shalinee Chawla, MD 516-663-2004 ext 2004

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
Principal Investigator: Shalinee Chawla, MD Winthrop University Hospital
  More Information

Responsible Party: Shalinee Chawla, MD, Principal Investigator, Winthrop University Hospital Identifier: NCT01744145     History of Changes
Other Study ID Numbers: 255021-4
Study First Received: September 20, 2012
Last Updated: December 4, 2012

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on April 25, 2017