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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Aynur Demirel, PT, PhD contact

+905545295057

aynur.demirel@hacettepe.edu.tr

Hidaye Yamikan, PT,MSc contact

+905349898724

hidaye.yamikan@hacettepe.edu.tr

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

Other trials in Turkey (Türkiye)

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 groups in NCT06483776
Study groupRoleWhat they receive
COPDPatients with Chronic Obstructive Pulmonary Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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)
  1. Functional exercise capacity

    Functional exercise capacity will be determined via Six Minute Walk Test.

    Measured: 1 day

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Peripheral muscle strength

    Peripheral muscle strength will be assessed via hand dynamometer.

    Measured: 1 day

  8. Lower extremity capacity

    One minute sit to stand test will be used for lower extremity capacity.

    Measured: 1 day

  9. Hand grip test

    Hand grip will be evaluated via hand dynamometer.

    Measured: 1 day

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted3 Jul 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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)
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

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.

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