Pulmonary Rehabilitation and Smoking

September 13, 2018 updated by: Ilknur Naz, Izmir Katip Celebi University

Effectiveness of Pulmonary Rehabilitation in Smoker Patients With COPD

Pulmonary rehabilitation (PR) is known to reduce dyspnea, increase exercise capacity, reduce psychological symptoms and improve quality of life in COPD patients. Some patients continue to smoke despite their illness. Smoking does not create a contraindication to PR. There is insufficient evidence on the effectiveness of PR programs in smoking COPD patients. The purpose of this study, PR completed the program to determine the effectiveness of PR smoker COPD patients.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Pulmonary rehabilitation (PR) is known to reduce dyspnea, increase exercise capacity, reduce psychological symptoms and improve quality of life in COPD patients. Some patients continue to smoke despite their illness. Smoking does not create a contraindication to PR. There is insufficient evidence on the effectiveness of PR programs in smoking COPD patients. The purpose of this study, PR completed the program to determine the effectiveness of PR smoker COPD patients. People who have completed the PR program, smoking and not smoking will be included into the study.

Data of carbon monoxide diffusion test, body plethysmography, 6-min walk test, blood gas analysis, mMRC dyspnea scale, hospital anxiety depression scale, SGRQ and SF-36 quality of life questionnaire performed before and after the program will be analyzed.

Study Type

Interventional

Enrollment (Actual)

31

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:

  • COPD patients completed 8 PR program

Exclusion Criteria:

  • Never smoked patients
  • Participated PR program in last year

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smoking
8 week exercise program consists of breathing exercises, strength training and endurance training
8 week exercise program
Experimental: Ex- Smoking
8 week exercise program consists of breathing exercises, strength training and endurance training
8 week exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minute walk test
Time Frame: 6 minutes
It was performed in a 30-meter long corridor in accordance with American Thoracic
6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function Test
Time Frame: 20 minutes
It was used for assessment of lung functions
20 minutes
Dyspnea Severity
Time Frame: 5 minues
MMRC Dyspnea Scale (0: no dyspnea, 4: very severe dyspnea), It was used for dyspnea that patients felt during their daily activities.
5 minues
St. George Disease Related Quality of Life Scale
Time Frame: 20 minutes
A disease-specific quality of life scale (Max. score:100, lower score means better quality of life level)
20 minutes
Short Form-36 Quality of Life Survey
Time Frame: 25 minutes
A health related quality of life scale, Short Form-36 Quality of Life Survey (Max. score:100, higher score means better quality of life level)
25 minutes
Hospital Anxiety and Depression Inventory
Time Frame: 20 minutes
It was used for assessment of anxiety and depression
20 minutes

Collaborators and Investigators

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

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, 2015

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ikçü (Other Identifier: Katip Çelebi University)

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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