Comorbidity and Pulmonary Rehabilitation in COPD

October 19, 2017 updated by: Ilknur Naz, Izmir Katip Celebi University

The Effect of Severity of Co-morbidity on Outcomes of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients

Our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is associated not only with respiratory system effects but also with systemic outcomes leading to numerous chronic comorbidities, and it is well known that patients benefit from pulmonary rehabilitation programs. However, the effect of presence of comorbidity on the outcome of pulmonary rehabilitation in patients with COPD is not clear. Therefore, our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes We included a total of 173 patients referred to the Izmir Suat Seren Chest Diseases and Surgery Training and Research Hospital Pulmonary Rehabilitation Unit. Comorbidities were recorded based on self reports. Charlson Comorbid Indexes (CCI) were calculated. Patients who defined at least one comorbidity were divided into two groups according to CCI; 1-3 as Group 1 and 4 and above as Group 2. Six minute walk test, mMRC dyspnea scale, SGRQ Respiratory Disease Questionnaire, respiratory function tests and arterial blood gases performed for assessment of patients before and after 16 sessions of pulmonary rehabilitation program.

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low Comorbidity Index Score
CCI; 1-3 as Group 1
Other: Exercise
Pulmonary Rehabilitation Program for 8 weeks
Other: High Comorbidity Index Score
CCI; 4 and above as Group 2
Other: Exercise
Pulmonary Rehabilitation Program for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: 6 minute
Six minute walk test
6 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Functions
Time Frame: 30 minutes
Pulmonary Function Tests
30 minutes
Dyspnea
Time Frame: 5 minutes
MMRC dyspnea scale
5 minutes
Disease Specific Quality of Life
Time Frame: 20 minutes
St George Respiratory Questionnaire
20 minutes
Health Related Quality of Life
Time Frame: 20 minutes
SF-36
20 minutes

Collaborators and Investigators

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

Sponsor

Izmir Katip Celebi University

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)

January 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IzmirKCU5

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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