Pulmonary Disease, Chronic ObstructiveNCT06298994
Determination of Body Awareness and the Functional Movement in Patients With COPD
An observational study of Pulmonary Disease, Chronic Obstructive and Postural; Defect, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Postural; Defect, Movement, Abnormal
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Mar 2024to 8 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with COPD and aged matched healthy controls will be included in this study.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aynur Demirel
Ankara, 06100
Hacettepe University
Ankara, 06100
Aynur Demirel, +905545295057 ext. 178, aynur.demirel@hacettepe.edu.tr
hidaye yamikan, +905349898724, hidaye.yamikan@hacettepe.edu.tr
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyskinesias, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Patients with Chronic Obstructive Pulmonary Disease | |
| control group | Aged-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of functional movement
Functional movement analysis will be performed via The Functional Movement Screen.
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (10)
Functional exercise capacity
Functional exercise capacity will be assessed via Six minute walk test.
Measured: 1 day
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.
Measured: 1
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.
Measured: 1 day
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.
Measured: 1 day
Pain threshold
Pain threshold will be assessed via an algometer.
Measured: 1 day
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.
Measured: 1 day
Daily living activities
Daily living activities will be evaluated via Glittre Activities of Daily Living Test.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start8 Mar 2024 (estimated)
- Primary completion8 Mar 2025 (estimated)
- Study completion8 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298994
- Sponsor's protocol ID
- SBA 23/391
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kronik Obstrüktif Akciğer Hastalığında Vücut Farkındalığı, Fonksiyonel Hareket Analizi ve İlişkili Parametrelerin Belirlenmesi
- ClinicalTrials.gov ID
- NCT06298994
- Acronym / sponsor ID
- SBA 23/391
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 8 Mar 2024 (estimated)
- Primary completion
- 8 Mar 2025 (estimated)
- Study completion
- 8 Mar 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Patients with Chronic Obstructive Pulmonary Disease |
| control group | – | –Aged-matched healthy controls |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with COPD and aged matched healthy controls will be included in this study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of functional movement
Time frame: 1 day
Functional movement analysis will be performed via The Functional Movement Screen.
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.
10 secondary outcomes
Functional exercise capacity
Time frame: 1 day
Respiratory muscle strength
Time frame: 1
Respiratory muscle endurance
Time frame: 1 day
Pain Severity
Time frame: 1 day
Pain threshold
Time frame: 1 day
Posture
Time frame: 1 day
Daily living activities
Time frame: 1 day
Severity of disease
Time frame: 1 day
Dyspnea
Time frame: 1 day
Symptoms
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Postural; Defect, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aynur Demirel, PhD (+905545295057, aynur.demirel@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of functional movement (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.