Clinical trial NCT01744145: Effect of Exercise and Education After Pneumonia
Official title: Early Pneumonia Intervention to Prevent Chronic Complications in Patients Age 40 and Above
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumonia
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: improvement in quality of life indices
timeFrame: one year
Secondary outcomes:
measure: improvement in functional status
timeFrame: one year
measure: change in 6 minute walk test
timeFrame: one year
measure: exercise intolerance
timeFrame: one year
measure: immunization
timeFrame: one year
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hosptial
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Shalinee Chawla, MD
role: PRINCIPAL_INVESTIGATOR
References: