Determination of Factors Effecting Falls in Patients With COPD
NCT Number: NCT06483776
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Disease, Chronic Obstructive|Fall|Balance; Distorted
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-06-01
Locations: Hacettepe University, Ankara, 06100, Turkey

Summary:
The aim of this study is to determine the factors affecting falls in patients with COPD.

Primary Outcome Measures: 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., 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., 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., 1 day
Secondary Outcome Measures: Functional exercise capacity, Functional exercise capacity will be determined via Six Minute Walk Test., 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., 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., 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., 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., 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., 1 day|Peripheral muscle strength, Peripheral muscle strength will be assessed via hand dynamometer., 1 day|Lower extremity capacity, One minute sit to stand test will be used for lower extremity capacity., 1 day|Hand grip test, Hand grip will be evaluated via hand dynamometer., 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., 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., 1 day|Upper Extremity Functional Capacity, Upper extremity functional capacity will be assessed by six minute pegboard and ring test in patients with COPD, 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., 1 day