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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06099002
Other study ID # KKU-FTR-YK-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 30, 2023
Est. completion date August 30, 2024

Study information

Verified date December 2023
Source Kirikkale University
Contact Meral Sertel, Associate professor
Phone 5355286059
Email fzt_meralaksehir@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A descriptive study evaluating balance, gait speed, Quadriceps Femoris muscle strength and quality of life in individuals with Chronic obstructive pulmonary disease (COPD) who fell and did not fall.


Description:

Falls in the elderly can have devastating consequences. The ability to maintain stability and balance is critical for functional independence, mobility, and avoidance of falls in activities of daily living. An impaired balance is associated with an increased risk of falls and causes a higher mortality rate among older adults. Balance impairment is independently associated with falls in patients with Chronic obstructive pulmonary disease. Well-known risk factors for falls in individuals with Chronic obstructive pulmonary disease include advanced age, increased comorbidities, dyspnea, physical inactivity, muscle weakness, fear and decreased balance confidence, as well as lower extremity muscle weakness. It has been reported that there are functional deficiencies, lack of performance and postural control. According to the results of a recent study, it was found that Chronic obstructive pulmonary disease is in the second place after osteoarthritis in chronic conditions where the prevalence of falls is highest. The prevalence of falls in individuals with Chronic obstructive pulmonary disease is estimated to range from 25% to 46%.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years to 84 Years
Eligibility Inclusion Criteria: - Being diagnosed with COPD according to criteria - Not having had an attack in the last 2 months - Volunteering to participate in the study - Being 65 years or older - Not having any mental or communication problems that prevent filling out the surveys to be used in the research. Exclusion Criteria: - Having unstable COPD - Unstable angina, previous Myocardial Infarction, uncontrolled hypertension, cancer, neurological or musculoskeletal diseases with functional limitations - Being currently addicted to alcohol or drugs - Being in the process of COPD exacerbation - Having severe vision and hearing problems - Having severe cognitive impairment - Having had major surgery in the last few months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scale
All individuals were given a respiratory function test to evaluate respiratory functions before and after training Modified Medical research Council to evaluate dyspnea, Mini Mental Test to evaluate cognitive status , Berg Balance Test to evaluate balance, 2-minute walk test to evaluate walking speed. A hand dynamometer will be used to measure QuadricepsFemoris muscle strength, Fall efficiency scale Fall risk self-assessment scale will be used to evaluate falls.

Locations

Country Name City State
Turkey Kirikkale High Specialization Hospital Kirikkale Merkez

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fall Effectiveness Scale It contains 10 questions. Each question is given a score between 1-10. 1 point means very confident, 10 points means not at all confident. A patient with a score above 70 is said to have a fear of falling. 15.04.2023-30.09.2024
Secondary To measure balance Berg Balance Scala To assess balance. The highest score is 56, scores between 0-20 indicate that the balance is disrupted, 21-41 indicates that the balance is acceptable, and 41-56 indicates that the balance is good. 15.04.2023-30.09.2024
Secondary Quadriceps Femoris muscle strength falling and non-falling individuals with COPD We measure the strength of the muscle by applying pressure from the knee with the help of a hand dynamometer. 15.04.2023-30.09.2024
Secondary Two Minute Walk Test The patient walks the longest distance he can in 2 minutes and the value is recorded in meters. The aim is to measure the patient's functional capacity. 15.04.2023-30.09.2024
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