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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05746702
Other study ID # GO 22/903
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date October 19, 2024

Study information

Verified date July 2023
Source Hacettepe University
Contact Aynur Demirel, PhD
Phone +90 3123051576
Email aynur.demirel@hacettepe.edu.tr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The former aim of this study is to determine whether the arm swings change in patients with Chronic Obstructive Pulmonary Disease (COPD) according to healthy subjects. The latter purposes to investigate the correlation between balance parameters and arm swing, how to change arm swing according to severity of the disease, and to determine the relationship between balance and the severity of disease, the relationship of posture both arm swing and severity of disease in patients with COPD. In accordance with this purposes, 20 patients with COPD who have Global Initiative for Chronic Obstruction Lung Disease (GOLD) stage 1-2-3 and 20 healthy controls will be included between the ages of 40 and 65, respectively. Tests and questionnaires will be used in order to determine the severity of COPD and to evaluate posture. Berg Balance Scale, Time Up and Go Test, 6 Minute Pegboard and Ring Test, 6 Minute Walk Test and gait analysis will be performed. It is expected that by determining the parameters that can be affected by severity of COPD. It is estimate to have information about severity of the disease by means of observational analysis. It will guide professional working in the field.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 19, 2024
Est. primary completion date June 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - Who has been clinically stable for the last 4 weeks, - who will be able to walk independently for 6 minutes, - According to the Classification of Airflow Limitation in COPD (GOLD) system, the Stage is 1-2-3, - who declares that he has not taken part in any other research Exclusion Criteria: - walking assistive devices, - receiving chronic oxygen therapy, - with central and peripheral vestibular disease, - with orthopedic, neuromuscular, neurological and cardiac diseases that may affect gait and balance, - with a history of lung cancer, sarcoidosis, tuberculosis and/or lung surgery, - who has communication problems, - with mental and cognitive problems

Study Design


Locations

Country Name City State
Turkey Aynur Demirel Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arm Swings Characteristics Change of the arm swings during 6 minute gait in patients with Chronic Obstructive Pulmonary Disease according to healthy subjects. 1 day
Secondary Spatiotemporal Characteristic Change of the spatiotemporal characteristic during 6 minute gait in patients with Chronic Obstructive Pulmonary Disease according to healthy subjects. 1 day
Secondary Upper Extremity Functional Capacity Upper extremity functional capacity by 6 minute pegboard and ring test in patient with Chronic Obstructive Pulmonary Disease 1 day
Secondary Balance Balance by Berg Balance Scale and Time Up Go Test in patient with Chronic Obstructive Pulmonary Disease 1 day
Secondary Severity of Disease severity of disease by GOLD ( Global Initiative for Chronic Obstructive Pulmonary Disease) , CAT ( Chronic Respiratory Questionnaire), Pulmonary Function Test in patient with Chronic Obstructive Pulmonary Disease 1 day
Secondary Posture posture by Corbin Posture Analyses Form in patient with Chronic Obstructive Pulmonary Disease 1 day
Secondary Functional Exercise Capacity Functional exercise capacity by six minute gait test in patients with Chronic Obstructive Pulmonary Disease. 1 day
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