- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06099002
Balance, Walking Speed, Quadriceps Femoris Muscle Strength and Quality of Life in Falling and Non-falling Individuals With COPD
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Merkez
-
Kırıkkale, Merkez, Turkey, 71100
- Kirikkale High Specialization Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Individuals with COPD over the age of 65 with a history of falls
Individuals with COPD who were over the age of 65 and had a history of falling were included in this group.
|
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. |
|
Individuals with COPD who are over the age of 65 and have no history of falling
Individuals with COPD who were over the age of 65 and did not have a history of falling were included in this group.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fall Effectiveness Scale
Time Frame: 15.04.2023-30.09.2024
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To measure balance Berg Balance Scala
Time Frame: 15.04.2023-30.09.2024
|
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
|
|
Quadriceps Femoris muscle strength falling and non-falling individuals with COPD
Time Frame: 15.04.2023-30.09.2024
|
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
|
|
Two Minute Walk Test
Time Frame: 15.04.2023-30.09.2024
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KKU-FTR-YK-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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