Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation

August 23, 2018 updated by: Christen DiPerna, Indiana University Health Methodist Hospital

Factors Predicting Success in Lung Transplant Recipients Who Have Participated in the COLTT Program (Daily Intensive Post-hospitalization Rehabilitation): A Retrospective Review

This is a retrospective review of the COLTT program outcomes and factors that predict recovery of functional status after lung transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Center of Life for Thoracic Transplant (COLTT) program is a daily (5 days per week) intensive rehabilitation program for patients who have undergone lung transplant. Patients are enrolled in COLTT as part of standard care after hospital discharge. This study is a retrospective review of seventy patients that measures the efficacy of the COLTT program and establishes predictors of patient success.This study will also measure the effect of functional outcomes on hospital readmission post COLTT discharge.

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lung transplant recipients at IU Health Methodist Hospital. As part of standard care, all patients who survive to hospital discharge are referred by transplant pulmonologists to the COLTT program.

Description

Inclusion Criteria:

  • All patients who completed the COLTT program from May, 2016 to July, 2017.

Exclusion Criteria:

  • Any COLTT patients who were not new lung transplant recipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach program goals (days)
Time Frame: Through study completion, an average of 4 weeks
The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures)
Through study completion, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed (mph, % expected)
Time Frame: Through study completion, an average of 4 weeks
Gait speed (walking speed) is measured daily on a oval track
Through study completion, an average of 4 weeks
Single leg stance performance (seconds, % expected)
Time Frame: Through study completion, an average of 4 weeks
The test result of a single leg stance test. Patients stand with hands on their hips, raise one leg off the ground and hold it for as long as possible.
Through study completion, an average of 4 weeks
One-minute sit to stand performance (number, % expected)
Time Frame: Through study completion, an average of 4 weeks
The test result of a one-minute sit to stand test. Patients stand/sit from a chair as many times as they can in one minute.
Through study completion, an average of 4 weeks
Six minute walk distance (feet, % expected)
Time Frame: Through study completion, an average of 4 weeks
The test result of a six-minute walk test, a field test of exercise capacity
Through study completion, an average of 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital readmission
Time Frame: 6 months
Measured as number of hospital readmissions
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University Health Methodist Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2017

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • RCS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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