Pulmonary Disease, Chronic ObstructiveNCT06483776
Determination of Factors Effecting Falls in Patients With COPD
An observational study of Pulmonary Disease, Chronic Obstructive and Fall, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the factors affecting falls in patients with COPD. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Fall, Balance; Distorted
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Jun 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD s will be included in this study.
Inclusion Criteria for Chronic Obstructive Pulmonary Disease Group;
- Being between the ages of 45 and 80,
- Being literate,
- Willing to participate in the study,
- Having COPD classified as stage 1-2-3-4 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) system,
- Being clinically stable for the past 4 weeks.
Exclusion Criteria for Chronic Obstructive Pulmonary Disease Group;
- Having a history of lung cancer, sarcoidosis, tuberculosis, and/or lung surgery,
- Having any neurological, neuromuscular, vestibular, or cardiac disease that could affect the measurements,
- Receiving long-term oxygen therapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, 06100
Aynur Demirel, PhD, +905545295057, aynur.demirel@hacettepe.edu.tr
Hidaye Yamikan, MSc, +905349898724, hidaye.yamikan@hacettepe.edu.tr
About this study
Official title: Kronik Obstrüktif Akciğer Hastalığında Düşmeye Etki Eden Faktörlerin Belirlenmesi
The aim of this study is to determine the factors affecting falls in patients with COPD.
Read the detailed description
The aim of this study is to determine the factors affecting falls in patients with COPD. In accordance with the purposes, at least 100 patients with COPD who are 45-80 years old and clinically stable for four weeks will be included. Tests and questionnaires will be used in order to determine the severity of disease. Lung function test and respiratory muscle strength will be performed. Six Minute Walk Test and Six Minute Pegboard and Ring test will be performed with an armband that measures energy expenditure for functional exercise capacity for functional exercise capacity. To evaluate posture, the Corbin Postural Assessment Scale will be used. Hand grip test, periphreal muscle strength test, Time up and go test and One minute sit to stand test will be performed. International Physical Activity Questionnaire - Short Form (IPAQ) will be used to determine physical activity level. Mini- Besttest and Activity-specific Balance Confidence Scale were used to determine fall risk. According to the results to be obtained factors affecting falls will be determined in patients with COPD. It will guide professional working in this field.
- 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 |
|---|---|---|
| COPD | Patients with Chronic Obstructive Pulmonary Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance and Fall risk
Time up and go test will be used to assess balance and fall risk. The cut off point will be determined as 12 second for patients with COPD.
Measured: 1 day
Balance and Fall risk-The Mini-Balance Evaluation Systems Test (Mini-BESTest)
It will be used to evaluate individuals' static and dynamic balance. It consists of four sub-parameters: preparatory movements, reactive postural control, sensory orientation, and dynamic gait, with a total of four items. The test, which takes an average of 10-15 minutes to complete, is evaluated out of a total of 28 points. A higher score indicates higher function. This test is valid and reliable in patients with COPD.
Measured: 1 day
Balance and Fall risk- The Activities-specific Balance Confidence scale (ABC scale)
It will be used to evaluate fall risk. A validity and reliability study has been conducted in Turkish. This scale assesses balance confidence based on functional status with 16 task-specific questions. Each question is scored between 0% (no confidence) and 100% (full confidence), and a higher total score indicates higher confidence. Scores below 67% indicate fall risk in elderly individuals. It is valid and reliable for determining fall risk in individuals with COPD.
Measured: 1 day
Secondary outcomes (13)
Functional exercise capacity
Functional exercise capacity will be determined via Six Minute Walk Test.
Measured: 1 day
Respiratory Muscle Strength
Respiratory muscle strength will be assessed via a using a mouth pressure device according to American Thoracic Society/ European Respiratory Society guidelines.
Measured: 1 day
Posture
Posture will be examined via the Corbin Postural Assessment Scale. The total points of the Corbin Postural Assessment Scale range from 0 to 28 points. A higher point represents worse posture.
Measured: 1 day
Dyspnea
The Modified Medical Research Council will be used for patients with COPD. The Modified Medical Research Council consist of five grades. A higher grades represents severe dyspnea level.
Measured: 1 day
Symptoms
Chronic Obstructive Pulmonary Disease Assessment Test will be used to determine symptoms. The total score of Chronic Obstructive Pulmonary Disease Assessment Test changes from 0 to 40 points, and 10 points is the accepted cut-off point for COPD.
Measured: 1 day
Severity of disease
Global Initiative for Chronic Obstructive Pulmonary Disease and Global Initiative for Chronic Obstructive Pulmonary ABE assessment Tool will be used for severity of disease. According to the Global Initiative for Chronic Obstructive Pulmonary Disease, the severity of airflow limitation (Forced Expiratory Volume in 1 s) was determined as mild (≥ 80%), moderate (50-80%), severe (30-50%), and very severe (<30%). According to Global Initiative for Chronic Obstructive Pulmonary A,B,E assessment Tool, patients classified group A, B, and E using symptom status and airflow limitation.
Measured: 1 day
Peripheral muscle strength
Peripheral muscle strength will be assessed via hand dynamometer.
Measured: 1 day
Lower extremity capacity
One minute sit to stand test will be used for lower extremity capacity.
Measured: 1 day
Hand grip test
Hand grip will be evaluated via hand dynamometer.
Measured: 1 day
Energy expenditure
An armband will be used to assess energy expenditure during six minute walk test and six minute pegboard and ring test.
Measured: 1 day
Physical activity
Individuals' physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form. The questionnaire, developed by Craig et al. (2003), has been validated and tested for reliability in Turkish by Öztürk et al. (2005). In the assessment of activities, each activity must be performed for at least 10 minutes at a time. The IPAQ short form provides information about time spent sitting, walking, in moderate-intensity activities, and in vigorous-intensity activities. A score is obtained by multiplying the duration in minutes, the number of days, and the MET (metabolic equivalent) value, resulting in a "MET-minutes/week" score. According to the scoring system, the intensity of physical activity is classified as low if the score is less than 600 MET-minutes/week, moderate if between 600 and 3000, and high if more than 3000.
Measured: 1 day
Upper Extremity Functional Capacity
Upper extremity functional capacity will be assessed by six minute pegboard and ring test in patients with COPD
Measured: 1 day
Bode index
It will be used to assess the risk of mortality due to COPD. This assessment includes body mass index (BMI), airway obstruction (FEV1 % predicted), dyspnea (mMRC dyspnea score), and exercise capacity (6-minute walk distance) in this index. BMI >21 is scored as 0, and ≤21 is scored as 1. Airway obstruction reflected by FEV1 (% predicted) is scored as follows: ≥65 is 0, 50-64 is 1, 36-49 is 2, and ≤35 is 3. The degree of dyspnea according to the mMRC scale is scored as follows: mMRC scores 0-1 are 0 in the BODE index, 2 is 1, 3 is 2, and 4 is 3. Finally, for exercise capacity, a 6MWD ≥350m is scored as 0, 250-349m is 1, 150-249m is 2, and ≤149m is 3 in the BODE index. The total score is determined by summing the individual scores. The BODE index can predict not only mortality but also the risk of hospitalization.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
- Investigators
- Aynur Demirel, PT, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483776
- Sponsor's protocol ID
- SBA 24/519
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kronik Obstrüktif Akciğer Hastalığında Düşmeye Etki Eden Faktörlerin Belirlenmesi
- ClinicalTrials.gov ID
- NCT06483776
- Acronym / sponsor ID
- SBA 24/519
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Jul 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 aim of this study is to determine the factors affecting falls in patients with COPD.
Detailed description
The aim of this study is to determine the factors affecting falls in patients with COPD. In accordance with the purposes, at least 100 patients with COPD who are 45-80 years old and clinically stable for four weeks will be included. Tests and questionnaires will be used in order to determine the severity of disease. Lung function test and respiratory muscle strength will be performed. Six Minute Walk Test and Six Minute Pegboard and Ring test will be performed with an armband that measures energy expenditure for functional exercise capacity for functional exercise capacity. To evaluate posture, the Corbin Postural Assessment Scale will be used. Hand grip test, periphreal muscle strength test, Time up and go test and One minute sit to stand test will be performed. International Physical Activity Questionnaire - Short Form (IPAQ) will be used to determine physical activity level. Mini- Besttest and Activity-specific Balance Confidence Scale were used to determine fall risk. According to the results to be obtained factors affecting falls will be determined in patients with COPD. It will guide professional working in this field.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –Patients with Chronic Obstructive Pulmonary Disease |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD s will be included in this study.
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
Balance and Fall risk
Time frame: 1 day
Time up and go test will be used to assess balance and fall risk. The cut off point will be determined as 12 second for patients with COPD.
Balance and Fall risk-The Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: 1 day
It will be used to evaluate individuals' static and dynamic balance. It consists of four sub-parameters: preparatory movements, reactive postural control, sensory orientation, and dynamic gait, with a total of four items. The test, which takes an average of 10-15 minutes to complete, is evaluated out of a total of 28 points. A higher score indicates higher function. This test is valid and reliable in patients with COPD.
Balance and Fall risk- The Activities-specific Balance Confidence scale (ABC scale)
Time frame: 1 day
It will be used to evaluate fall risk. A validity and reliability study has been conducted in Turkish. This scale assesses balance confidence based on functional status with 16 task-specific questions. Each question is scored between 0% (no confidence) and 100% (full confidence), and a higher total score indicates higher confidence. Scores below 67% indicate fall risk in elderly individuals. It is valid and reliable for determining fall risk in individuals with COPD.
13 secondary outcomes
Functional exercise capacity
Time frame: 1 day
Respiratory Muscle Strength
Time frame: 1 day
Posture
Time frame: 1 day
Dyspnea
Time frame: 1 day
Symptoms
Time frame: 1 day
Severity of disease
Time frame: 1 day
Peripheral muscle strength
Time frame: 1 day
Lower extremity capacity
Time frame: 1 day
Hand grip test
Time frame: 1 day
Energy expenditure
Time frame: 1 day
Physical activity
Time frame: 1 day
Upper Extremity Functional Capacity
Time frame: 1 day
Bode index
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
Aynur Demirel, PT, PhD principal investigator
Hacettepe University
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 Pulmonary Disease, Chronic Obstructive and Fall, 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?
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 3 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aynur Demirel, PT, PhD (+905545295057, aynur.demirel@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance and Fall risk (time frame: 1 day). The study lists 3 primary outcomes in all. 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 3 Jul 2024.