Chronic Obstructive Pulmonary DiseaseNCT05632120
Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions in COPD
An observational study of Chronic Obstructive Pulmonary Disease and Balance, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional study aims to investigate to the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in Chronic Obstructive Pulmonary Diseases (COPD) patients. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Balance, Activity, Motor
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2022to 30 Mar 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants will be patients with COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines were recruited from Istanbul University, Department of Chest Diseases.
Who may be able to join
- stable disease (no severe exacerbations in the prior 3 months)
- ability to walk independently
- ability to read and write in Turkish
- able to follow simple instructions
- no pathology in visual ability and hearing
Who cannot join
- a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder)
- severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
- use of medication(s) that may increase the risk of falls
- participate in pulmonary rehabilitation in the lasts six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University
Istanbul, Fatih/İstanbul, 34452
About this study
Official title: Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions According to the ICF Framework in Chronic Obstructive Pulmonary Diseases
This cross-sectional study aims to investigate to the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in Chronic Obstructive Pulmonary Diseases (COPD) patients.
Read the detailed description
To investigate the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in patients with COPD, fifty patients with COPD will be included.
The Modified Medical Research Council Dyspnea (MMRC) scale and Six-Minute Walking Test (6MWT) will be used for evaluating the how dyspnea limits the patients' daily activities and functional capacity, respectively. Isometric muscle strength will be measured with a handheld dynamometer of quadriceps femoris. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. The level of dyspnea during daily activities will be assessed with London Chest Activity of Daily Living (LCADL) scale. The global impacts of COPD symptoms on overall health status will be evaluated by The COPD Assessment Test (CAT). Pulmonary function data will be retrieved from the last 1-month clinical records of the COPD patients. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 21.0. Descriptive statistics of continuous variables will be presented with mean, standard deviation (SD), confidence interval (CI) values, and descriptive statistics of categorical variables will be presented with frequency and percentage values. The conformity of the data to the normal distribution will be evaluated with the "Shapiro Wilk Test". According to the results of the analysis, "Pearson correlation test" or "Spearman correlation test" will be used to determine the relationship between dependent variables. The significance level will be set as p<0.05.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Patient Participation
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities-Specific Balance Confidence scale
Activities-Specific Balance Confidence (ABC) scale will be used for evaluating the confidence in maintaining the balance in activities daily living. It provides information on the level of concern about falls during16 community-based and home-based activities. Scale scores between 0 (unsafe) to 100 (completely safe) and the total score (0-1600) is divided by 16 to obtain an individual's ABC score, with higher scores indicating greater balance confidence. In patients with COPD, the ABC scale has demonstrated construct validity as well as criterion validity for falls. In addition, the participants will be also questioned concerning the occurrence of falls and the risk of falling during the activity in each item of the ABC scale.
Measured: Baseline
Secondary outcomes (5)
London Chest Activity of Daily Living scale
London Chest Activity of Daily Living (LCADL) scale is used for assessing the level of dyspnea during daily activities.
It is a 15-item scale comprised 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). Each item scored between 0 (I wouldn't do it anyway) to 5 (I need help in doing this or someone to do it for me) and the total score ranges from 0 to 75, with higher scores indicating a more significant limitation in daily activities.
The LCADL scale is a reliable, valid, and responsive instrument to assess limitations in performing daily activities in COPD patients. asked to rate each item in terms of risk of falling using a five-point scale, where 1=very low, 2=low, 3=moderate, 4=high, and 5=very high.
Measured: Baseline
The COPD Assessment Test
The COPD Assessment Test (CAT) will be used for evaluating the global impacts of COPD symptoms on overall health status. Each item scores between 0 to 5 and the total score ranges from 0 to 40, with higher scores indicating the more severe impact of COPD on health status.
Measured: Baseline
The strength of quadriceps femoris
The strength of quadriceps femoris of both sides will be measured with a hand-held dynamometer (kg.N-1) ''Nicholas Manual Muscle Tester" (model 01160, The Lafayette Instrument Company, Lafayette, Indiana). Each limb will assessed 3 times, with a recovery period of 30 seconds and the mean value will be calculated.
Measured: Baseline
The Modified Medical Research Council Dyspnea scale
The Modified Medical Research Council Dyspnea (mMRC) scale will be used to determine how dyspnea limits the patients' daily activities performance. Itis a five-level rating scale consisting of just five items containing statements about the impact of dyspnea on the patients' daily activities performance and leading to a grade from 1 to 5. Higher scores indicate a greater impact of dyspnea on the patients' daily activities performance.
Measured: Baseline
Six-Minute Walking Test (6MWT)
Six-Minute Walking Test (6MWT) is a reliable and valid test for evaluating functional capacity. Two 6MWTs will be performed according to the guidelines of the American Thoracic Society. The distance in meters covered over the 6 minutes of the test (6MWD) will be recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start5 Dec 2022
- Primary completion25 Feb 2023
- Study completion30 Mar 2025 (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 Istanbul University - CerrahpasaThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medeniyet University, Biruni University, Istanbul University
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University - Cerrahpasa
- Investigators
- Tansu Birinci, PT, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632120
- Sponsor's protocol ID
- 212121
- Status last verified
- Jun 2024
- First submitted
- 20 Nov 2022
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions According to the ICF Framework in Chronic Obstructive Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT05632120
- Acronym / sponsor ID
- 212121
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Istanbul Medeniyet University, Biruni University, Istanbul University
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 30 Nov 2022 (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.
This cross-sectional study aims to investigate to the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in Chronic Obstructive Pulmonary Diseases (COPD) patients.
Detailed description
To investigate the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in patients with COPD, fifty patients with COPD will be included.
The Modified Medical Research Council Dyspnea (MMRC) scale and Six-Minute Walking Test (6MWT) will be used for evaluating the how dyspnea limits the patients' daily activities and functional capacity, respectively. Isometric muscle strength will be measured with a handheld dynamometer of quadriceps femoris. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. The level of dyspnea during daily activities will be assessed with London Chest Activity of Daily Living (LCADL) scale. The global impacts of COPD symptoms on overall health status will be evaluated by The COPD Assessment Test (CAT). Pulmonary function data will be retrieved from the last 1-month clinical records of the COPD patients. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 21.0. Descriptive statistics of continuous variables will be presented with mean, standard deviation (SD), confidence interval (CI) values, and descriptive statistics of categorical variables will be presented with frequency and percentage values. The conformity of the data to the normal distribution will be evaluated with the "Shapiro Wilk Test". According to the results of the analysis, "Pearson correlation test" or "Spearman correlation test" will be used to determine the relationship between dependent variables. The significance level will be set as p<0.05.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be patients with COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines were recruited from Istanbul University, Department of Chest Diseases.
Key inclusion criteria (5 listed)
- stable disease (no severe exacerbations in the prior 3 months)
- ability to walk independently
- ability to read and write in Turkish
- able to follow simple instructions
- no pathology in visual ability and hearing
Key exclusion criteria (4 listed)
- a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder)
- severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
- use of medication(s) that may increase the risk of falls
- participate in pulmonary rehabilitation in the lasts six months
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-Specific Balance Confidence scale
Time frame: Baseline
Activities-Specific Balance Confidence (ABC) scale will be used for evaluating the confidence in maintaining the balance in activities daily living. It provides information on the level of concern about falls during16 community-based and home-based activities. Scale scores between 0 (unsafe) to 100 (completely safe) and the total score (0-1600) is divided by 16 to obtain an individual's ABC score, with higher scores indicating greater balance confidence. In patients with COPD, the ABC scale has demonstrated construct validity as well as criterion validity for falls. In addition, the participants will be also questioned concerning the occurrence of falls and the risk of falling during the activity in each item of the ABC scale.
5 secondary outcomes
London Chest Activity of Daily Living scale
Time frame: Baseline
The COPD Assessment Test
Time frame: Baseline
The strength of quadriceps femoris
Time frame: Baseline
The Modified Medical Research Council Dyspnea scale
Time frame: Baseline
Six-Minute Walking Test (6MWT)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Tansu Birinci, PT, PhD principal investigator
Istanbul University - Cerrahpasa
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 Balance, run by Istanbul University - Cerrahpasa 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 5 inclusion and 4 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 30 Jan 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?
Results are not available in the source record.
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-Specific Balance Confidence scale (time frame: Baseline). 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 30 Jan 2025.