Chronic Obstructive Pulmonary DiseaseNCT04074499
The Risk of Falling in Patients with Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Fall, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional study aims to investigate what daily activities increase the risk of falling in Chronic Obstructive Pulmonary Disease patients (COPD). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Fall, Balance; Distorted
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2019to 3 Dec 2019
- 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-Cerrahpasa
Istanbul, Bakırkoy, 34147
About this study
Official title: What Daily Activities Increase the Risk of Falling in Chronic Obstructive Pulmonary Disease Patients?
This cross-sectional study aims to investigate what daily activities increase the risk of falling in Chronic Obstructive Pulmonary Disease patients (COPD).
Read the detailed description
To investigate the what daily activities increase the risk of falling in patients with COPD, twenty-eight voluntary patients with COPD, aged between 35-80 years will be divided into two groups: Group-1 have at least one fall (fallers) and Group-2 have no history of falls (non-fallers). Fall frequency will be investigated by asking patients to report any fall event in the last one month and the last 12-months. Assessments will be performed at baseline. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. Balance will be evaluated by Berg Balance Scale (BBS). 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). 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. 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. Among the groups, demographic and clinical variables will be compared with independent sample t-test for continuous variables and a chi-square test for categorical variables. The significance level will be set as p<0.05.
- Being tested
- No intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | The patients were classified based on the frequency of falls in the last 12 months.
Group-1 consists of COPD patients whose have at least one fall (fallers) Receives: Other: No intervention | |
| Group-2 | The patients were classified based on the frequency of falls in the last 12 months.
Group-2 consists of COPD patients whose have no history of falls (non-fallers). Receives: Other: No intervention |
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 (7)
Fall frequency
Fall frequency will be investigated by asking patients to report any fall event in the last one month and the last 12-months. Participants will be asked: "Have you had any fall including a slip or trip in which you lost your balance and landed on the floor or ground or lower level?" Details about the circumstances of the fall and any resultant injury will be questioned.
Measured: Baseline
Berg Balance Scale
Berg Balance Scale (BBS) will be used to assess the balance and determine the risk of falling in participants. It consists of 14-item evaluating a patient's ability to safely balance during a series of physical tasks. Scale scores between 0 (unable/unsafe) to 4 (independent/safe) and the total score ranges from 0 to 56, with higher scores indicating better balance control. The BBS has been demonstrated construct validity in patients with COPD.
Measured: Baseline
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 Aug 2019
- Study start31 Aug 2019
- Primary completion22 Oct 2019
- Study completion3 Dec 2019
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University - Cerrahpasa
- Investigators
- Tansu Birinci, MSc, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074499
- Sponsor's protocol ID
- 459535
- Status last verified
- Mar 2020
- First submitted
- 28 Aug 2019
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Daily Activities Increase the Risk of Falling in Chronic Obstructive Pulmonary Disease Patients?
- ClinicalTrials.gov ID
- NCT04074499
- Acronym / sponsor ID
- 459535
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 30 Aug 2019 (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 what daily activities increase the risk of falling in Chronic Obstructive Pulmonary Disease patients (COPD).
Detailed description
To investigate the what daily activities increase the risk of falling in patients with COPD, twenty-eight voluntary patients with COPD, aged between 35-80 years will be divided into two groups: Group-1 have at least one fall (fallers) and Group-2 have no history of falls (non-fallers). Fall frequency will be investigated by asking patients to report any fall event in the last one month and the last 12-months. Assessments will be performed at baseline. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. Balance will be evaluated by Berg Balance Scale (BBS). 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). 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. 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. Among the groups, demographic and clinical variables will be compared with independent sample t-test for continuous variables and a chi-square test for categorical variables. The significance level will be set as p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-1 | – | Other: No interventionThe patients were classified based on the frequency of falls in the last 12 months. Group-1 consists of COPD patients whose have at least one fall (fallers) |
| Group-2 | – | Other: No interventionThe patients were classified based on the frequency of falls in the last 12 months. Group-2 consists of COPD patients whose have no history of falls (non-fallers). |
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention. | Other | Group-1, Group-2 |
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.
7 secondary outcomes
Fall frequency
Time frame: Baseline
Berg Balance Scale
Time frame: Baseline
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
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 8 Oct 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.
Tansu Birinci, MSc 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 Fall, 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: finished, as of the sponsor's last update on 8 Oct 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?
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-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 8 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.