- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06298994
Determination of Body Awareness and the Functional Movement in Patients With COPD
March 5, 2024 updated by: Aynur Demirel, Hacettepe University
Kronik Obstrüktif Akciğer Hastalığında Vücut Farkındalığı, Fonksiyonel Hareket Analizi ve İlişkili Parametrelerin Belirlenmesi
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.
Study Overview
Status
Not yet recruiting
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aynur Demirel, PhD
- Phone Number: +905545295057
- Email: aynur.demirel@hacettepe.edu.tr
Study Contact Backup
- Name: Hidaye Yamikan, PT,MSc
- Phone Number: +905349898724
- Email: hidaye.yamikan@hacettepe.edu.tr
Study Locations
-
-
-
Ankara, Turkey, 06100
- Hacettepe University
-
Contact:
- Aynur Demirel
- Phone Number: 178 +905545295057
- Email: aynur.demirel@hacettepe.edu.tr
-
Contact:
- hidaye yamikan
- Phone Number: +905349898724
- Email: hidaye.yamikan@hacettepe.edu.tr
-
Sub-Investigator:
- hidaye yamikan
-
Sub-Investigator:
- cansu akkus
-
Ankara, Turkey, 06100
- Aynur Demirel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients with COPD and aged matched healthy controls will be included in this study.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
study group
Patients with Chronic Obstructive Pulmonary Disease
|
|
control group
Aged-matched healthy controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of functional movement
Time Frame: 1 day
|
Functional movement analysis will be performed via The Functional Movement Screen.
|
1 day
|
|
Evaluation of Body Awareness
Time Frame: 1 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional exercise capacity
Time Frame: 1 day
|
Functional exercise capacity will be assessed via Six minute walk test.
|
1 day
|
|
Respiratory muscle strength
Time Frame: 1
|
Respiratory muscle strength will be assessed via a using a mouth pressure device according to American Thoracic Society/ European Respiratory Society guidelines.
|
1
|
|
Respiratory muscle endurance
Time Frame: 1 day
|
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
|
|
Pain Severity
Time Frame: 1 day
|
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
|
|
Pain threshold
Time Frame: 1 day
|
Pain threshold will be assessed via an algometer.
|
1 day
|
|
Posture
Time Frame: 1 day
|
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
|
|
Daily living activities
Time Frame: 1 day
|
Daily living activities will be evaluated via Glittre Activities of Daily Living Test.
|
1 day
|
|
Severity of disease
Time Frame: 1 day
|
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
|
|
Dyspnea
Time Frame: 1 day
|
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
|
|
Symptoms
Time Frame: 1 day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 8, 2024
Primary Completion (Estimated)
March 8, 2025
Study Completion (Estimated)
March 8, 2026
Study Registration Dates
First Submitted
February 27, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 7, 2024
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBA 23/391
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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