Chronic Obstructive Pulmonary DiseaseNCT05746702
Investigation of Arm Swings Characteristics in Patient With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Postural; Defect, run by Hacettepe University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Postural; Defect, Gait, Unsteady
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 19 Oct 2024
- How long will I take part?
- 7 Days
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred by the department of chest diseases of Hacettepe university will be taken.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aynur Demirel
Ankara, 06100
Aynur Demirel, PhD, 05545295057, aynur.demirel@hacettepe.edu.tr
hidaye Yamıkan
About this study
Official title: Kronik Obstrüktif Akciğer Hastalığında Yürüyüş Sırasında Yürüyüşün Zaman Mesafe Karakteristikleri ve Kol Salınımlarının İncelenmesi
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.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Gait Disorders, Neurologic, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Swings Characteristics
Change of the arm swings during 6 minute gait in patients with Chronic Obstructive Pulmonary Disease according to healthy subjects.
Measured: 1 day
Secondary outcomes (6)
Spatiotemporal Characteristic
Change of the spatiotemporal characteristic during 6 minute gait in patients with Chronic Obstructive Pulmonary Disease according to healthy subjects.
Measured: 1 day
Upper Extremity Functional Capacity
Upper extremity functional capacity by 6 minute pegboard and ring test in patient with Chronic Obstructive Pulmonary Disease
Measured: 1 day
Balance
Balance by Berg Balance Scale and Time Up Go Test in patient with Chronic Obstructive Pulmonary Disease
Measured: 1 day
Severity of Disease
severity of disease by GOLD ( Global İnitiative for Chronic Obstructive Pulmonary Disease) , CAT ( Chronic Respiratory Questionnaire), Pulmonary Function Test in patient with Chronic Obstructive Pulmonary Disease
Measured: 1 day
Posture
posture by Corbin Posture Analyses Form in patient with Chronic Obstructive Pulmonary Disease
Measured: 1 day
Functional Exercise Capacity
Functional exercise capacity by six minute gait test in patients with Chronic Obstructive Pulmonary Disease.
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 posted28 Feb 2023
- Study start1 Mar 2023
- Primary completion19 Jun 2024 (estimated)
- Study completion19 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 40 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
- Investigators
- Aynur Demirel, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746702
- Sponsor's protocol ID
- GO 22/903
- Status last verified
- Jul 2023
- First submitted
- 30 Jan 2023
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kronik Obstrüktif Akciğer Hastalığında Yürüyüş Sırasında Yürüyüşün Zaman Mesafe Karakteristikleri ve Kol Salınımlarının İncelenmesi
- ClinicalTrials.gov ID
- NCT05746702
- Acronym / sponsor ID
- GO 22/903
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 19 Jun 2024 (estimated)
- Study completion
- 19 Oct 2024 (estimated)
- First posted
- 28 Feb 2023 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred by the department of chest diseases of Hacettepe university will be taken.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
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
Arm Swings Characteristics
Time frame: 1 day
Change of the arm swings during 6 minute gait in patients with Chronic Obstructive Pulmonary Disease according to healthy subjects.
6 secondary outcomes
Spatiotemporal Characteristic
Time frame: 1 day
Upper Extremity Functional Capacity
Time frame: 1 day
Balance
Time frame: 1 day
Severity of Disease
Time frame: 1 day
Posture
Time frame: 1 day
Functional Exercise Capacity
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 6 Jul 2023.
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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.
Aynur Demirel, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Postural; Defect, run by Hacettepe University at 1 site 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 4 inclusion and 7 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (+90 3123051576 ext. 178, 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?
Arm Swings Characteristics (time frame: 1 day). 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 6 Jul 2023.