NCT01744145

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 18, 2023

Status Verified

January 1, 2016

Enrollment Period

4.3 years

First QC Date

September 20, 2012

Last Update Submit

April 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • improvement in functional status

    one year

  • change in 6 minute walk test

    one year

  • exercise intolerance

    one year

  • immunization

    one year

Study Arms (4)

Interventional 40-60

ACTIVE COMPARATOR

Interventional group aged 40-60

Other: Interventional 40-60

Control 40-60

NO INTERVENTION

Control group aged 40-60

Interventional 60 and above

ACTIVE COMPARATOR

Interventional group aged 60 and above

Other: Interventional 60 and above

Control 60 and above

NO INTERVENTION

Control group aged 60 and above

Interventions

This group will receive the intervention aged 40-60

Interventional 40-60

This group will receive the intervention aged 60 and above.

Interventional 60 and above

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of CAP or HCAP via radiographic imaging and symptoms of pneumonia Age 40 and above.
  • Discharge to home.
  • Ability to read and sign consent.
  • Ability to perform in procedures/exercise.
  • Ability to understand educational component of the program.
  • Antibiotic administration for pneumonia within 12 hours of admission.

You may not qualify if:

  • Severe lung diseases like ILD(Interstitial Lung disease), ARDS (Adult Respiratory Distress Syndrome.)
  • Ventilator dependent patients.
  • Discharge to nursing home.
  • Comorbidity that could limit exercise training.
  • Dementia, Schizophrenia or any active severe psychiatric disorder.
  • Any Active Malignancy or diagnosis of Lung malignancy.
  • Inability to attend program two times per week.
  • Recent myocardial infarction within two months.
  • Unstable angina, Heart failure (NYHA class III and IV.)
  • Patients with pneumonia who did not receive antibiotics within 12 hours of admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hosptial

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shalinee Chawla, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

December 6, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 18, 2023

Record last verified: 2016-01

Locations