Effect of Exercise and Education After Pneumonia (EPICC)

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.

Study Overview

• Status: Terminated
• Conditions: Pneumonia
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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
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.
No Intervention: Control 40-60; Control group aged 40-60
No Intervention: Control 60 and above; Control group aged 60 and above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Winthrop University Hospital
• Investigators: Principal Investigator: Shalinee Chawla, MD, Winthrop University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 255021-4