Effect of Exercise and Education After Pneumonia

Pneumonia Clinical Trial

— EPICC  

Official title:

Early Pneumonia Intervention to Prevent Chronic Complications in Patients Age 40 and Above

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01744145
• Other study ID #: 255021-4
• Status: Terminated
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• Interventional 40-60
This group will receive the intervention aged 40-60
• Interventional 60 and above
This group will receive the intervention aged 60 and above.

Locations

Country	Name	City	State
United States	Winthrop University Hosptial	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

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