COPDNCT04765969
Determination of Factors Related With Daily Living Activities in Severe COPD
An observational study of COPD, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of chronic obstructive pulmonary disease (COPD) rehabilitation applications is to increase the functional capacity of the patients and improve the quality of life in daily living activities (ADL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COPD
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2019to 30 Jun 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD subjects who were referred to the Bezmialem Vakıf University
Who may be able to join
- Pulmonary function tests (PFT) value of FEV₁ / FVC <70%,
- Being in GOLD III-IV groups,
- Being over 18 years old,
- Being able to read and to understand the spoken language.
Who cannot join
- subjects have had COPD exacerbation in the last six weeks,
- having comorbidities affecting ambulation and
- cognitive disorders.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of chronic obstructive pulmonary disease (COPD) rehabilitation applications is to increase the functional capacity of the patients and improve the quality of life in daily living activities (ADL). Therefore, the investigators planned the study to determine the influence of ADL and related factors in severe COPD.
GOLD C and D COPD patients admitted to Bezmialem Vakif University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Pulmonary Rehabilitation Application and Research Laboratory will be included in this study on a voluntary basis. Individuals who have experienced exacerbations of COPD in the last 6 weeks, have comorbidities affecting ambulation and have cognitive impairment will be excluded. Physical and sociodemographic characteristics of all participants will be recorded. Spirometric measurement will used to evaluate pulmonary functions, London Chest Activities Scale (LCADL) will used to evaluate daily living activities, six minute walking test (6MWT) will used to evaluate functional capacity, and mouth pressure will measured to evaluate respiratory muscle strength. (MIP: maximal inspiratory pressure, MEP: maximal expiratory pressure). Saint George Respiratory Questionnaire (SGRQ) for assessing quality of life, International Physical Activity Questionnaire (IPAQ) for assessing physical activity, COPD Assessment Test (CAT) for symptom assessment, and Hospital Anxiety and Depression Scale (HAD) for anxiety and depression assessment will be applied. SPSS 22.0 package program will be used in statistical analysis. For descriptive statistics, mean ± standard deviation values will be calculated and Pearson correlation test will be used in correlation analysis. p <0.05 will be the level of significance.
- Conditions
- COPD
- Keywords
- COPD, Activities of Daily Living
- 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 |
|---|---|---|
| Severe COPD patients | GOLD C and D group patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of daily living
The LCADL Scale is going to used to assess dyspnea resulting from ADL . It consists of a total of 15 items within four domains: personal care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). Each item is graded from 0 to 5 with higher scores indicating more difficulty performing ADL. The scale can be evaluated as total score, domain scores, and item scores. The maximum total score is 75. There is also a single question that assesses to what degree dyspnea perception affects daily life in general. This item is answered by selecting one of three responses: 'a lot', 'a little', or 'not at all'
Measured: 6 months
Secondary outcomes (10)
Pulmonary Function Test
Spirometer is performed according to the American Thoracic Society (ATS) guidelines in Bezmialem University PFT Laboratory with Zan-100 spire (nSpire Health GmbH, Oberthulba, Germany). FVC (l), FEV₁(l), FEV1(%), FEV₁/FVC (%) were recorded.
Measured: 6 months
FEV1 (liter)
This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.
Measured: 6 months
FEV1 (%-percentage)
This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.
Measured: 6 months
FVC (liter)
This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
Measured: 6 months
FEV1/FVC (percentage)
The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.
Measured: 6 months
Inspiratory muscle test
Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Measured: 6 months
Functional capacity
Functional capacity is going to assessed with the 6 minute walk test (6MWT) according to the guideline of ATS .
Measured: 6 months
Symptoms
For the symptom burden of COPD, COPD Assessment Test (CAT) is going to used. It consists of eight items, each presented as a semantic 6-point differential scale, providing a score out of 40 indicating the impact of the disease
Measured: 6 months
Physical activity
It provides information about time spent on walking, moderate to severe activities. Time spent in sitting is considered as a separate question. The calculation of the total score of the short form includes the sum of walking, moderate intensity activity, and duration (minutes) and frequency (days) of intensive activity.
Measured: 6 months
Expiratory muscle test
Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start18 Jan 2019
- Primary completion28 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765969
- Sponsor's protocol ID
- ssaka1
- Status last verified
- Aug 2025
- First submitted
- 16 Mar 2020
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our clinical datas' are not available for sharig considering ethical problems.
Publications
Ozsoy I, Ozcan Kahraman B, Acar S, Ozalevli S, Akkoclu A, Savci S. Factors Influencing Activities of Daily Living in Subjects With COPD. Respir Care. 2019 Feb;64(2):189-195. doi: 10.4187/respcare.05938. Epub 2018 Nov 6.
PubMed 30401755Kapella MC, Larson JL, Covey MK, Alex CG. Functional performance in chronic obstructive pulmonary disease declines with time. Med Sci Sports Exerc. 2011 Feb;43(2):218-24. doi: 10.1249/MSS.0b013e3181eb6024.
PubMed 20543752
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Factors Related With Daily Living Activities in Severe COPD
- ClinicalTrials.gov ID
- NCT04765969
- Acronym / sponsor ID
- ssaka1
- Conditions
- COPD
- Keywords
- COPD, Activities of Daily Living
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 23 Feb 2021 (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 main purpose of chronic obstructive pulmonary disease (COPD) rehabilitation applications is to increase the functional capacity of the patients and improve the quality of life in daily living activities (ADL). Therefore, the investigators planned the study to determine the influence of ADL and related factors in severe COPD.
GOLD C and D COPD patients admitted to Bezmialem Vakif University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Pulmonary Rehabilitation Application and Research Laboratory will be included in this study on a voluntary basis. Individuals who have experienced exacerbations of COPD in the last 6 weeks, have comorbidities affecting ambulation and have cognitive impairment will be excluded. Physical and sociodemographic characteristics of all participants will be recorded. Spirometric measurement will used to evaluate pulmonary functions, London Chest Activities Scale (LCADL) will used to evaluate daily living activities, six minute walking test (6MWT) will used to evaluate functional capacity, and mouth pressure will measured to evaluate respiratory muscle strength. (MIP: maximal inspiratory pressure, MEP: maximal expiratory pressure). Saint George Respiratory Questionnaire (SGRQ) for assessing quality of life, International Physical Activity Questionnaire (IPAQ) for assessing physical activity, COPD Assessment Test (CAT) for symptom assessment, and Hospital Anxiety and Depression Scale (HAD) for anxiety and depression assessment will be applied. SPSS 22.0 package program will be used in statistical analysis. For descriptive statistics, mean ± standard deviation values will be calculated and Pearson correlation test will be used in correlation analysis. p <0.05 will be the level of significance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe COPD patients | – | –GOLD C and D group patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD subjects who were referred to the Bezmialem Vakıf University
Key inclusion criteria (4 listed)
- Pulmonary function tests (PFT) value of FEV₁ / FVC <70%,
- Being in GOLD III-IV groups,
- Being over 18 years old,
- Being able to read and to understand the spoken language.
Key exclusion criteria (3 listed)
- subjects have had COPD exacerbation in the last six weeks,
- having comorbidities affecting ambulation and
- cognitive disorders.
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
Activities of daily living
Time frame: 6 months
The LCADL Scale is going to used to assess dyspnea resulting from ADL . It consists of a total of 15 items within four domains: personal care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). Each item is graded from 0 to 5 with higher scores indicating more difficulty performing ADL. The scale can be evaluated as total score, domain scores, and item scores. The maximum total score is 75. There is also a single question that assesses to what degree dyspnea perception affects daily life in general. This item is answered by selecting one of three responses: 'a lot', 'a little', or 'not at all'
10 secondary outcomes
Pulmonary Function Test
Time frame: 6 months
FEV1 (liter)
Time frame: 6 months
FEV1 (%-percentage)
Time frame: 6 months
FVC (liter)
Time frame: 6 months
FEV1/FVC (percentage)
Time frame: 6 months
Inspiratory muscle test
Time frame: 6 months
Functional capacity
Time frame: 6 months
Symptoms
Time frame: 6 months
Physical activity
Time frame: 6 months
Expiratory muscle test
Time frame: 6 months
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 15 Aug 2025.
- Results publication: PubMed 30401755Ozsoy I, Ozcan Kahraman B, Acar S, Ozalevli S, Akkoclu A, Savci S. Factors Influencing Activities of Daily Living in Subjects With COPD. Respir Care. 2019 Feb;64(2):189-195. doi: 10.4187/respcare.05938. Epub 2018 Nov 6.
- Results publication: PubMed 20543752Kapella MC, Larson JL, Covey MK, Alex CG. Functional performance in chronic obstructive pulmonary disease declines with time. Med Sci Sports Exerc. 2011 Feb;43(2):218-24. doi: 10.1249/MSS.0b013e3181eb6024.
- Individual participant dataSharing planned: No. Our clinical datas' are not available for sharig considering ethical problems.
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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, run by Halic 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 3 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 15 Aug 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?
Activities of daily living (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765969, which also lists 2 linked publications.
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 15 Aug 2025.