Effect of Exercise and Education After Pneumonia (EPICC)
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 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|
- improvement in quality of life indices [ Time Frame: one year ] [ Designated as safety issue: No ]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
- improvement in functional status [ Time Frame: one year ] [ Designated as safety issue: No ]
- change in 6 minute walk test [ Time Frame: one year ] [ Designated as safety issue: No ]
- exercise intolerance [ Time Frame: one year ] [ Designated as safety issue: No ]
- immunization [ Time Frame: one year ] [ Designated as safety issue: No ]Patients will be assessed to see if education offered in the interventional group will effect compliance with vaccination.
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744145
|Contact: Abid I Khokar, MD||516-663-2004 ext firstname.lastname@example.org|
|Contact: Shalinee Chawla, MD||516-663-2004 ext email@example.com|
|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|
|Principal Investigator:||Shalinee Chawla, MD||Winthrop University Hospital|