Re-Rehabilitation in Chronic Obstrctive Pulmonary Disease

July 2, 2019 updated by: Ilknur Naz, Izmir Katip Celebi University

The Effect of Re-Rehabilitation in Patients With COPD

Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pulmonary rehabilitation (PR) program in patients with COPD reduces dyspnea perception, increases exercise capacity, improves quality of life, and reduces psychological symptoms. Unfortunately, these gains are not permanent, but disappear within 12-24 months. The aim of this study is to compare the gains of the second PR program with the first program.

Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.

Study Type

Interventional

Enrollment (Actual)

22

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

Description

Inclusion Criteria:

  • Above 18 years
  • Completed PR program

Exclusion Criteria:

-

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COPD patients participated PR program
COPD patients participated first and second PR program
Other: Rehabilitation program
exercise program twice a week
Other Names:
  • exercise

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Functions
Time Frame: 30 minutes
Pulmonary Function Test
30 minutes
Dyspnea Sensation
Time Frame: 5 minutes
We used "Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. The score "1" represents the best level, where the score "5" indicates the poorest.
5 minutes
Disease Specific Quality of Life
Time Frame: 20 minutes
We used St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms.
20 minutes
Anxiety and Depression
Time Frame: 20 minutes
Hospital Anxiety and Depression (HAD) Inventory was used for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
20 minutes

Collaborators and Investigators

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

Sponsor

Izmir Katip Celebi University

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)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IzmirKCU1

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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