Determination of Body Awareness and the Functional Movement in Patients With COPD

Pain Clinical Trial

Official title:

Kronik Obstrüktif Akciğer Hastalığında Vücut Farkındalığı, Fonksiyonel Hareket Analizi ve İlişkili Parametrelerin Belirlenmesi

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298994
• Other study ID #: SBA 23/391
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Dyskinesias
• Movement, Abnormal
• Pain
• Postural; Defect
• Pulmonary Disease, Chronic Obstructive

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