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Effect of Exercise and Education After Pneumonia (EPICC)

Primary Purpose

Pneumonia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interventional 40-60
Interventional 60 and above
Sponsored by
Winthrop University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pneumonia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Winthrop University Hosptial

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Interventional 40-60

Control 40-60

Interventional 60 and above

Control 60 and above

Arm Description

Interventional group aged 40-60

Control group aged 40-60

Interventional group aged 60 and above

Control group aged 60 and above

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

improvement in functional status
change in 6 minute walk test
exercise intolerance
immunization
Patients will be assessed to see if education offered in the interventional group will effect compliance with vaccination.

Full Information

First Posted
September 20, 2012
Last Updated
April 12, 2023
Sponsor
Winthrop University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01744145
Brief Title
Effect of Exercise and Education After Pneumonia
Acronym
EPICC
Official Title
Early Pneumonia Intervention to Prevent Chronic Complications in Patients Age 40 and Above
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
not enough enrollment
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Winthrop University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional 40-60
Arm Type
Active Comparator
Arm Description
Interventional group aged 40-60
Arm Title
Control 40-60
Arm Type
No Intervention
Arm Description
Control group aged 40-60
Arm Title
Interventional 60 and above
Arm Type
Active Comparator
Arm Description
Interventional group aged 60 and above
Arm Title
Control 60 and above
Arm Type
No Intervention
Arm Description
Control group aged 60 and above
Intervention Type
Other
Intervention Name(s)
Interventional 40-60
Intervention Description
This group will receive the intervention aged 40-60
Intervention Type
Other
Intervention Name(s)
Interventional 60 and above
Intervention Description
This group will receive the intervention aged 60 and above.
Primary Outcome Measure Information:
Title
improvement in quality of life indices
Description
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
Time Frame
one year
Secondary Outcome Measure Information:
Title
improvement in functional status
Time Frame
one year
Title
change in 6 minute walk test
Time Frame
one year
Title
exercise intolerance
Time Frame
one year
Title
immunization
Description
Patients will be assessed to see if education offered in the interventional group will effect compliance with vaccination.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalinee Chawla, MD
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hosptial
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States

12. IPD Sharing Statement

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Effect of Exercise and Education After Pneumonia

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