COPD (Chronic Obstructive Pulmonary Disease)NCT06677671
Comparison of Clinical Parameters in Chronic Obstructive Pulmonary Disease Patients and Healthy Individuals
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The investigators think that the functions of core stabilization muscles are different in chronic obstructive pulmonary disease (COPD) patients than in healthy individuals. This muscle group plays an important role not only in stabilization but also in respiratory parameters. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 18 Jul 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients and volunteer healthy individuals admitted to Ankara Etlik City Hospital
Who may be able to join
- Being diagnosed with COPD
- Being between the ages of 40-80
- Being clinically stable (not having had an exacerbation in the last month)
- Being able to cooperate with the tests
- Not participating in any exercise training studies
- Being willing to participate in the study
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- Being between the ages of 40-80
- Not having a known acute or chronic health problem that would prevent the performance of the tests or affect the performance of the tests
- Not participating in any exercise training program
- Being willing to participate in the study
Who cannot join
- Having other lung or lung involvement diseases other than COPD
- Having uncontrolled hypertension, arrhythmia and a history of myocardial infarction in the last month, unstable angina, advanced heart failure and other cardiac instability conditions
- Being hemodynamically unstable
- Being on noninvasive mechanical ventilation (NIMV) and long-term oxygen therapy (LTOT)
- Having a history of neuromuscular disease, scoliosis, chest wall surgery
- Having pregnancy and malignancy
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- Having orthopedic or surgical conditions that would prevent participation in tests
- Not willing to participate in the study
- Having a known acute or chronic health problem that would prevent the performance of the tests or affect the performance of the tests
- Being pregnant
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Exercise Capacity, Muscle Parameters and Quality of Life Parameters in Chronic Obstructive Pulmonary Disease Patients and Healthy Individuals
The investigators think that the functions of core stabilization muscles are different in chronic obstructive pulmonary disease (COPD) patients than in healthy individuals. This muscle group plays an important role not only in stabilization but also in respiratory parameters. No study has been found investigating the functions of these muscles in this patient group. The investigators aimed to compare respiratory parameters, muscle parameters, exercise capacity, balance, quality of life, anxiety and depression levels in individuals with COPD and healthy individuals.
Read the detailed description
Individuals diagnosed with COPD between the ages of 40-80 who applied to Ankara Etlik City Hospital Chest Diseases Polyclinic will be included in the study. Healthy individuals will be between the ages of 40-80 who volunteered to participate in the study. Data collection tools will be made by the same researchers.
For calculating the sample size required for the study, a power analysis will be conducted using pilot data after evaluating 10 individuals with COPD and 10 healthy adults.
- Keywords
- copd, exercise capacity, muscle parameters
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Healthy | Healthy Individuals | |
| COPD | Chronic Obstructive Pulmonary Disease Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise test
Cardiopulmonary exercise test will be performed to evaluate the exercise capacity of the individuals who will participate in the study. During the test, individuals' respiratory and cardiac parameters will be recorded.
Measured: September 2024, July 2026
Secondary outcomes (9)
Respiratory function
Respiratory functions will be assessed using spirometry (Cosmed Microquark-PC Based Spirometer, Rome, Italy) according to the criteria of the European Respiratory Society (ERS) and the American Thoracic Society (ATS).
Measured: September 2024, July 2026
Respiratory muscle strength
Respiratory muscle strength will be assessed with a portable, electronic oral pressure measuring device (Cosmed Pony Fx, Milan, Italy). Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Percentage of expected reference values according to gender and age will be used for the MIP value. The clinical significance for this patient group is 17.2 cmH2O for the measured MIP value.
Measured: September 2024, July 2026
Muscle activity and muscle thickness
In our study, muscle activity and thickness of transversus abdominis (TrA), rectus abdominis (RA), lumbar multifidus (LM) and quadriceps muscles will be evaluated to evaluate muscle function. Muscle activity will be evaluated using surface electromyography (EMG) (Neuro-MEP, Ivanovo, Russia) and muscle thickness will be evaluated using ultrasound (LOGIQ P9, GE Healthcare, USA).
Measured: September 2024, July 2026
COPD Assessment Questionnaire
The COPD Assessment Test (CAT) will be used to assess health status impairment in individuals with COPD. The CAT is an eight-item test consisting of questions that evaluate the severity of symptoms such as dyspnea, cough, and sputum production and the impact of the disease on daily life. It is recommended that the minimal clinical significance is a change of 2 points.
Measured: September 2024, July 2026
Timed up and go test
The Timed Up and Go Test (TUG) will be used for the balance assessment of individuals participating in the study. TUG is a frequently used, easily applicable, valid and reliable, performance-based functional mobility and balance test that evaluates dynamic balance in the clinic. It has been shown that dynamic balance impairment in COPD is associated with inadequate oxygenation and peripheral muscle weakness. Individuals who complete the test in 12 seconds or more have a risk of falling
Measured: September 2024, July 2026
Functional reach test
Functional reach test will be used for the balance assessment of individuals participating in the study. Individuals who can reach 25 cm and more have a low risk of falling. Individuals who can reach between 15-25 cm have a 2 times higher risk of falling than normal. Individuals who can reach 15 cm and below have a 4 times higher risk of falling than normal. Individuals who cannot reach at all have an 8 times higher risk of falling than normal.
Measured: September 2024, July 2026
St George Health Questionnaire
St. George's Respiratory Questionnaire (SGRQ), a seventy-six-item health-related quality of life assessment questionnaire, will be used to assess the quality of life of the subjects.The result values are between 0 and 100 and the higher the value, the greater the degree to which the patient's quality of life is affected by the disease.
Measured: September 2024, July 2026
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression (HAD) scale will be used to determine the anxiety and depression levels of individuals participating in the study. This scale is a self-report scale that includes anxiety and depression subscales and consists of 14 items, seven of which investigate depression and seven of which investigate anxiety levels.The cut-off point for the anxiety subscale of the HAD Turkish form was found to be 10 and the cut-off point for the depression subscale was found to be 7. Patients who score above these points can be considered as a risk group. Anxiety and depression score 07: normal, 8-11: borderline, >11: anxiety and depression.
Measured: September 2024, July 2026
Six Minute Walk Test (6MWT)
6MWT will be used to evaluate the exercise capacities of individuals who will participate in the study. The individuals' walking distance and cardiac parameters during the test will be recorded.
Measured: September 2024- July 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Sep 2024
- Primary completion18 Jul 2026 (estimated)
- Study completion18 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Cansu Özkılıçaslan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677671
- Sponsor's protocol ID
- AEŞH-BADEK-2024-553
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exercise Capacity, Muscle Parameters and Quality of Life Parameters in Chronic Obstructive Pulmonary Disease Patients and Healthy Individuals
- ClinicalTrials.gov ID
- NCT06677671
- Acronym / sponsor ID
- AEŞH-BADEK-2024-553
- Keywords
- copd, exercise capacity, muscle parameters
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 18 Jul 2026 (estimated)
- Study completion
- 18 Jul 2026 (estimated)
- First posted
- 7 Nov 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 investigators think that the functions of core stabilization muscles are different in chronic obstructive pulmonary disease (COPD) patients than in healthy individuals. This muscle group plays an important role not only in stabilization but also in respiratory parameters. No study has been found investigating the functions of these muscles in this patient group. The investigators aimed to compare respiratory parameters, muscle parameters, exercise capacity, balance, quality of life, anxiety and depression levels in individuals with COPD and healthy individuals.
Detailed description
Individuals diagnosed with COPD between the ages of 40-80 who applied to Ankara Etlik City Hospital Chest Diseases Polyclinic will be included in the study. Healthy individuals will be between the ages of 40-80 who volunteered to participate in the study. Data collection tools will be made by the same researchers.
For calculating the sample size required for the study, a power analysis will be conducted using pilot data after evaluating 10 individuals with COPD and 10 healthy adults.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy Individuals |
| COPD | – | –Chronic Obstructive Pulmonary Disease Patients |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients and volunteer healthy individuals admitted to Ankara Etlik City Hospital
Key inclusion criteria (10 listed)
- Being diagnosed with COPD
- Being between the ages of 40-80
- Being clinically stable (not having had an exacerbation in the last month)
- Being able to cooperate with the tests
- Not participating in any exercise training studies
Key exclusion criteria (11 listed)
- Having other lung or lung involvement diseases other than COPD
- Having uncontrolled hypertension, arrhythmia and a history of myocardial infarction in the last month, unstable angina, advanced heart failure and other cardiac instability conditions
- Being hemodynamically unstable
- Being on noninvasive mechanical ventilation (NIMV) and long-term oxygen therapy (LTOT)
- Having a history of neuromuscular disease, scoliosis, chest wall 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
Cardiopulmonary exercise test
Time frame: September 2024, July 2026
Cardiopulmonary exercise test will be performed to evaluate the exercise capacity of the individuals who will participate in the study. During the test, individuals' respiratory and cardiac parameters will be recorded.
9 secondary outcomes
Respiratory function
Time frame: September 2024, July 2026
Respiratory muscle strength
Time frame: September 2024, July 2026
Muscle activity and muscle thickness
Time frame: September 2024, July 2026
COPD Assessment Questionnaire
Time frame: September 2024, July 2026
Timed up and go test
Time frame: September 2024, July 2026
Functional reach test
Time frame: September 2024, July 2026
St George Health Questionnaire
Time frame: September 2024, July 2026
Hospital Anxiety and Depression Scale
Time frame: September 2024, July 2026
Six Minute Walk Test (6MWT)
Time frame: September 2024- July 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.
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 (Chronic Obstructive Pulmonary Disease), 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 10 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cardiopulmonary exercise test (time frame: September 2024, July 2026). 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 Nov 2024.