CopdNCT06099002
Balance, Walking Speed, Quadriceps Femoris Muscle Strength and Quality of Life in Falling and Non-falling Individuals With COPD
An observational study of Copd, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Copd
- What is being tested?
- Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scale
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2023to 30 May 2024
- 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 65 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Individuals with COPD over the age of 65
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirikkale High Specialization Hospital
Kirikkale, Merkez, 71100
About this study
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.
Read the detailed 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%.
- Conditions
- Copd
- Being tested
- Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scale
- 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.
Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scaleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | |
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15.04.2023-30.09.2024
Secondary outcomes (3)
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.
Measured: 15.04.2023-30.09.2024
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.
Measured: 15.04.2023-30.09.2024
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.
Measured: 15.04.2023-30.09.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start30 Dec 2023
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral SERTEL, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099002
- Sponsor's protocol ID
- KKU-FTR-YK-02
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance, Walking Speed, Quadriceps Femoris Muscle Strength and Quality of Life in Falling and Non-falling Individuals With COPD
- ClinicalTrials.gov ID
- NCT06099002
- Acronym / sponsor ID
- KKU-FTR-YK-02
- Conditions
- Copd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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%.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with COPD over the age of 65 with a history of falls | – | Other: Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scaleIndividuals with COPD who were over the age of 65 and had a history of falling were included in this group. |
| Individuals with COPD who are over the age of 65 and have no history of falling | – | Other: Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scaleIndividuals with COPD who were over the age of 65 and did not have a history of falling were included in this group. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Individuals with COPD over the age of 65
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changed Medical research Council,Mini Mental Test, Quadriceps Femoris muscle strength measurement,2 min walking test, fall effectiveness scale,Fall risk self-assessment scaleAll 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. | Other | Individuals with COPD over the age of 65 with a history of falls, Individuals with COPD who are over the age of 65 and have no history of falling |
Primary outcome
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.
3 secondary outcomes
To measure balance Berg Balance Scala
Time frame: 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
Two Minute Walk Test
Time frame: 15.04.2023-30.09.2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Copd
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd, run by Kırıkkale 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?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 15 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Effectiveness Scale (time frame: 15.04.2023-30.09.2024). 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 15 Oct 2024.