Effect of Exercise and Education After Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Interventional 40-60

Interventional group aged 40-60

Group Type ACTIVE_COMPARATOR

Interventional 40-60

Intervention Type OTHER

This group will receive the intervention aged 40-60

Control 40-60

Control group aged 40-60

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventional 60 and above

Interventional group aged 60 and above

Group Type ACTIVE_COMPARATOR

Interventional 60 and above

Intervention Type OTHER

This group will receive the intervention aged 60 and above.

Control 60 and above

Control group aged 60 and above

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Interventional 40-60

This group will receive the intervention aged 40-60

Intervention Type OTHER

Interventional 60 and above

This group will receive the intervention aged 60 and above.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes