- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03671187
Pulmonary Rehabilitation and Smoking
Effectiveness of Pulmonary Rehabilitation in Smoker Patients With COPD
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- COPD patients completed 8 PR program
Exclusion Criteria:
- Never smoked patients
- Participated PR program in last year
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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