Clinical Features of Smoker Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

• Conditions: Smoking; Copd
• Interventions: Other: Clinical Tests

• Registration Number: NCT04711629
• Lead Sponsor: Izmir Katip Celebi University

Brief Summary

Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want.

The aim of this study is; To examine patients with COPD who continue to smoke in terms of perception of dyspnea, exercise capacity, psychological symptoms and quality of life.

Detailed Description

The study was designed prospectively. Patients with COPD who apply to the pulmonary rehabilitation outpatient clinic will be included.

The data of patients with COPD who are eligible for PR and have been pre-evaluated will be scanned. Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale will be used in the study. Patients with COPD who smoke will constitute the study group, and those who quit smoking will constitute the control group.

Study Timeline

• Study First Submitted: 2020-11-05
• Status Verified: 2021-01
• Study Start: 2021-01
• Primary Completion: 2021-01
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Smoker COPD Patients who smoker

Exclusion Criteria

• Not volunteer to participate the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoker COPD	Clinical Tests	Patients who continue to smoke
Ex-smoker COPD	Clinical Tests	Patients who quit smoking.

Primary Outcome Measures

Name	Time	Method
Exercise Capacity	6 minutes	Six minutes walk test

Secondary Outcome Measures

Name	Time	Method
Dyspnea Sensation	20 minutes	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.
Anxiety	20 minutes	Hospital Anxiety and Depression (HAD) Inventory 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.
Depression	20 minutes	Hospital Anxiety and Depression (HAD) Inventory 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.
Body Mass Index	5 minutes	Body mass index is calculated by dividing body mass by the square of length in meters.
Respiratory Functions	30 minutes	Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.; FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).
Disease Specific Quality of Life	20 minutes	St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms.