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Determination of Factors Effecting Falls in Patients With COPD

Kronik Obstrüktif Akciğer Hastalığında Düşmeye Etki Eden Faktörlerin Belirlenmesi

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06483776
Enrollment
100
Registered
2024-07-03
Start date
2024-07-01
Completion date
2026-06-01
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance; Distorted, Fall, Pulmonary Disease, Chronic Obstructive

Brief summary

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.

Interventions

None listed

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Balance and Fall risk1 dayTime 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)1 dayIt 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)1 dayIt 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.

Secondary

MeasureTime frameDescription
Dyspnea1 dayThe 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.
Symptoms1 dayChronic 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.
Severity of disease1 dayGlobal 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.
Peripheral muscle strength1 dayPeripheral muscle strength will be assessed via hand dynamometer.
Lower extremity capacity1 dayOne minute sit to stand test will be used for lower extremity capacity.
Functional exercise capacity1 dayFunctional exercise capacity will be determined via Six Minute Walk Test.
Energy expenditure1 dayAn armband will be used to assess energy expenditure during six minute walk test and six minute pegboard and ring test.
Physical activity1 dayIndividuals' 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.
Upper Extremity Functional Capacity1 dayUpper extremity functional capacity will be assessed by six minute pegboard and ring test in patients with COPD
Bode index1 dayIt 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.
Hand grip test1 dayHand grip will be evaluated via hand dynamometer.
Respiratory Muscle Strength1 dayRespiratory muscle strength will be assessed via a using a mouth pressure device according to American Thoracic Society/ European Respiratory Society guidelines.
Posture1 dayPosture 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAynur Demirel, PT, PhD
aynur.demirel@hacettepe.edu.tr+905545295057
Backup ContactHidaye Yamikan, PT,MSc
hidaye.yamikan@hacettepe.edu.tr+905349898724

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026