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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06298994
Other study ID # SBA 23/391
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 8, 2024
Est. completion date March 8, 2026

Study information

Verified date March 2024
Source Hacettepe University
Contact Aynur Demirel, PhD
Phone +905545295057
Email aynur.demirel@hacettepe.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls.


Description:

It is aimed at investigating body awareness, and functional movement, and related factors in patients with COPD. The secondary purpose is to determine correlations between body awareness and functional movement, respiratory muscle strength and endurance, daily living activities, posture, and pain threshold in this study. The determination of correlations between functional movement, respiratory pattern, and functional exercise capacity is also purposed. In accordance with these purposes, at least 30 patients with COPD will be included and at least 30 healthy controls will be included. Tests and questionnaires will be used in order to determine the severity of disease. Lung function test and respiratory muscle strength and endurance test will be performed. Six Minute Walk Test will be performed for functional exercise capacity. To evaluate posture, the Corbin Postural Assessment Scale will be used. Pain and pain threshold will be assessed via Visual Analog Scale and an algometer, respectively. Body Awareness Rating Questionnaire will be used for evaluating body awareness. To evaluate daily living activities, Glittre Activities of Daily Living Test will be used. The Functional Movement Screen Test will be used for functional movement analysis. According to the results to be obtained, body awareness and functional movement will be determined in patients with COPD. It will guide professional working in this field.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 8, 2026
Est. primary completion date March 8, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria for Chronic Obstructive Pulmonary Disease Group - Being under 55 years old - To be literate, - Having volunteered to participate in the research, - Stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system, - Being clinically stable for the last 2 weeks. Exclusion Criteria for Chronic Obstructive Pulmonary Disease Group - Having history of lung cancer, sarcoidosis, tuberculosis and/or lung surgery, - Communication problems, - Having a severe psychiatric disorder. Inclusion Criteria for Healthy Control Group - Not having any cardiopulmonary system disease or chronic systemic disease, - To be literate, - Being under 55 years old - Be willing to participate in the study. - Not having balance problems, musculoskeletal, neurological and psychiatric disorders that could prevent performing the test procedures.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Aynur Demirel Ankara
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of functional movement Functional movement analysis will be performed via The Functional Movement Screen. 1 day
Primary Evaluation of Body Awareness Body awareness will be assessed via Body Awareness Rating Questionnaire. It consists of 24 questions and each item is scored on a 7-point Likert-type scale. The total score ranges from 24 to168. A Higher scores indicate higher body awareness. 1 day
Secondary Functional exercise capacity Functional exercise capacity will be assessed via Six minute walk test. 1 day
Secondary Respiratory muscle strength Respiratory muscle strength will be assessed via a using a mouth pressure device according to American Thoracic Society/ European Respiratory Society guidelines. 1
Secondary Respiratory muscle endurance Respiratory muscle endurance will be assessed using the maximal incremental loading technique and constant loading technique using a device according to the European Respiratory Society guidelines. 1 day
Secondary Pain Severity Severity of pain will be assessed via Visual Analog Scale. Zero point is defined as no pain and ten point as unbearable pain. Total point ranges from 0 to 10. 1 day
Secondary Pain threshold Pain threshold will be assessed via an algometer. 1 day
Secondary Posture Posture will be examined via the Corbin Postural Assessment Scale. The total points of the Corbin Postural Assessment Scale range from 0 to 28 points. A higher point represents worse posture. 1 day
Secondary Daily living activities Daily living activities will be evaluated via Glittre Activities of Daily Living Test. 1 day
Secondary Severity of disease Global Initiative for Chronic Obstructive Pulmonary Disease and Global Initiative for Chronic Obstructive Pulmonary ABE assessment Tool will be used for severity of disease. According to the Global Initiative for Chronic Obstructive Pulmonary Disease, the severity of airflow limitation (Forced Expiratory Volume in 1 s) was determined as mild (= 80%), moderate (50-80%), severe (30-50%), and very severe (<30%). According to Global Initiative for Chronic Obstructive Pulmonary A,B,E assessment Tool, patients classified group A, B, and E using symptom status and airflow limitation. 1 day
Secondary Dyspnea The Modified Medical Research Council will be used for patients with COPD. The Modified Medical Research Council consist of five grades. A higher grades represents severe dyspnea level. 1 day
Secondary Symptoms Chronic Obstructive Pulmonary Disease Assessment Test will be used to determine symptoms. The total score of Chronic Obstructive Pulmonary Disease Assessment Test changes from 0 to 40 points, and 10 points is the accepted cut-off point for COPD. 1 day
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