COPDNCT06442059
Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients
An observational study of COPD and Kinesiophobia Due to Dyspnea, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Patients diagnosed with COPD who applied to the Pulmonary Diseases Department of Kırıkkale Yüksek İhtisas Hospital will be included in the study. The aim of our study: It is aimed to investigate the effect of fear of movement due to dyspnea on respiratory function, muscle strength, physical performance and balance in… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- COPD, Kinesiophobia Due to Dyspnea
- What is being tested?
- Kinesiophobia Level Due to Dyspnea
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 28 Feb 2025
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included.
Who may be able to join
- Being diagnosed with COPD Be clinically stable for the last four weeks Not using antibiotics for the last four weeks being over 45 years old, Volunteering to participate in the study
Who cannot join
- Not being able to cooperate with the evaluations to be made, Having any physical disability that may affect walking and balance Having severe neuromuscular, musculoskeletal and rheumatological problems accompanying COPD
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saniye Aydoğan Arslan
Kirikkale, Kırıkkale, 71100
About this study
Official title: Examination of the Relationship Between Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients
Patients diagnosed with COPD who applied to the Pulmonary Diseases Department of Kırıkkale Yüksek İhtisas Hospital will be included in the study. The aim of our study: It is aimed to investigate the effect of fear of movement due to dyspnea on respiratory function, muscle strength, physical performance and balance in Chronic Obstructive Pulmonary Disease Patients.
Read the detailed description
At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included. The number of patients to be included in our study will be determined by power analysis.
Sociodemographic information (Age, Gender, Body Mass Index, Smoking history) of the individuals included in the research will be recorded.
Regarding COPD symptoms:
Whether the cough is productive or non-productive, its frequency and period Presence of sputum, type, amount, color, presence of hemoptysis, Presence of chest pain, Presence of peripheral edema, You will be asked about the presence of resting and/or exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea (PND).
- Respiratory Muscle Strength: It will be measured using an electronic, mobile, intraoral pressure measuring device.
- Peripheral Muscle Strength Evaluation: Quadriceps muscle strength will be evaluated using a dynomometer.
- Physical Performance: A 6-minute walk test will be used to determine the physical fitness levels of individuals.
- Balance Level: Mini-BEST Test will be used to determine the balance level
- Kinesiophobia Level Due to Dyspnea:
It will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ). When the literature was examined, no study was found that examined all of these factors together in patients with COPD. Existing studies have shown that the effects of variables are different and it is stated that more studies are needed.
- Conditions
- COPD, Kinesiophobia Due to Dyspnea
- Being tested
- Kinesiophobia Level Due to Dyspnea
- Keywords
- Chronic obstructive pulmonary disease, kinesiophobia, physical performance, dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Kinesiophobia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiophobia Level Due to DyspneaOther
Kinesiophobia Level Due to Dyspnea
| Study group | Role | What they receive |
|---|---|---|
| copd | Patients over the age of 45 who have been diagnosed with COPD and whose clinical condition is stable Receives: Other: Kinesiophobia Level Due to Dyspnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia Level Due to Dyspnea
It will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ).BBQ; It is a scale consisting of 11 questions that evaluates the person's kinesiophobia and anxiety due to breathlessness. Patients give scores to each question ranging from 1 (strongly disagree) to 5 (strongly agree). High scores indicate high levels of kinesiophobia and anxiety due to breathlessness.
Measured: 12 moon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Oct 2023
- Primary completion1 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saniye Aydoğan Arslan, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442059
- Sponsor's protocol ID
- Kırıkkaleu-Caglanyetim
- Status last verified
- Nov 2024
- First submitted
- 29 May 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Relationship Between Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients
- ClinicalTrials.gov ID
- NCT06442059
- Acronym / sponsor ID
- Kırıkkaleu-Caglanyetim
- Conditions
- COPD, Kinesiophobia Due to Dyspnea
- Keywords
- Chronic obstructive pulmonary disease, kinesiophobia, physical performance, dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 4 Jun 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.
Patients diagnosed with COPD who applied to the Pulmonary Diseases Department of Kırıkkale Yüksek İhtisas Hospital will be included in the study. The aim of our study: It is aimed to investigate the effect of fear of movement due to dyspnea on respiratory function, muscle strength, physical performance and balance in Chronic Obstructive Pulmonary Disease Patients.
Detailed description
At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included. The number of patients to be included in our study will be determined by power analysis.
Sociodemographic information (Age, Gender, Body Mass Index, Smoking history) of the individuals included in the research will be recorded.
Regarding COPD symptoms:
Whether the cough is productive or non-productive, its frequency and period Presence of sputum, type, amount, color, presence of hemoptysis, Presence of chest pain, Presence of peripheral edema, You will be asked about the presence of resting and/or exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea (PND).
- Respiratory Muscle Strength: It will be measured using an electronic, mobile, intraoral pressure measuring device.
- Peripheral Muscle Strength Evaluation: Quadriceps muscle strength will be evaluated using a dynomometer.
- Physical Performance: A 6-minute walk test will be used to determine the physical fitness levels of individuals.
- Balance Level: Mini-BEST Test will be used to determine the balance level
- Kinesiophobia Level Due to Dyspnea:
It will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ). When the literature was examined, no study was found that examined all of these factors together in patients with COPD. Existing studies have shown that the effects of variables are different and it is stated that more studies are needed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| copd | – | Other: Kinesiophobia Level Due to DyspneaPatients over the age of 45 who have been diagnosed with COPD and whose clinical condition is stable |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included.
Key inclusion criteria (1 listed)
- Being diagnosed with COPD Be clinically stable for the last four weeks Not using antibiotics for the last four weeks being over 45 years old, Volunteering to participate in the study
Key exclusion criteria (1 listed)
- Not being able to cooperate with the evaluations to be made, Having any physical disability that may affect walking and balance Having severe neuromuscular, musculoskeletal and rheumatological problems accompanying COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiophobia Level Due to DyspneaKinesiophobia Level Due to Dyspnea | Other | copd |
Primary outcome
Kinesiophobia Level Due to Dyspnea
Time frame: 12 moon
It will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ).BBQ; It is a scale consisting of 11 questions that evaluates the person's kinesiophobia and anxiety due to breathlessness. Patients give scores to each question ranging from 1 (strongly disagree) to 5 (strongly agree). High scores indicate high levels of kinesiophobia and anxiety due to breathlessness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD and Kinesiophobia Due to Dyspnea, run by Kırıkkale 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia Level Due to Dyspnea (time frame: 12 moon). 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 13 Mar 2025.