COPD (Chronic Obstructive Pulmonary Disease)NCT05811832
Evaluation in Elderly Individuals with Chronic Obstructive Pulmonary Disease(COPD)
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
This study is conducted on the evaluation of balance, physical activity, functional capacity and activities of daily living in frail elderly individuals with COPD. Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Evaluation
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 15 May 2024
- How long will I take part?
- 8 Months
- 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: Elderly individuals aged 65-84 years diagnosed with COPD who are frail or non-fragile.
Who may be able to join
- Being diagnosed with COPD according to the Gold criteria
- Be over 65 years old
- Volunteering to participate in the study
- Not having mental and communication problems that prevent filling out the questionnaires to be used in the research.
- Not having an attack in the last 2 months
Who cannot join
- Being in a COPD exacerbation process
- Having been diagnosed with a physical and mental illness
- Having unstable COPD
- Unstabile angina, previous Myocardial Infractus, uncontrolled hypertension, cancer, with functional limitations concomitant neurological or musculoskeletal disorders
- Currently addicted to alcohol or drugs
- Having severe vision and hearing problems
- Have had major surgery in the last few months
- History of recurrent significant clinical infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirikkale High Specialization Hospital
Kirikkale, Merkez, 71100
About this study
Official title: Evaluation of Balance, Physical Activity, Functional Capacity and Activities of Daily Living in Frail Elderly Individuals with COPD
This study is conducted on the evaluation of balance, physical activity, functional capacity and activities of daily living in frail elderly individuals with COPD.
Read the detailed description
Patient evaluation form and socio-demographic form of all individuals participating in the study. Characteristics will be questioned: Name-surname, address, telephone, age, gender, weight, height, body mass index, occupation, marital status, social security, any systemic other than COPD whether he has a disease, whether he has social security, whether he smokes, It will be questioned whether there is any other COPD patient in the family and whether there is pain. To assess pulmonary functions at the assessment stage for all individuals pulmonary function test to evaluate dyspnea Modified Medical Saint George Respiratory Research Council to assess health-related quality of life Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect frailty, Prisma-7 Vulnerability scale to assess fragility The scale was Pase to assess physical activity, Berg Balance to assess balance scale, digital hand dynamometer to assess quadriceps muscle strength, hand grip hand dynamometer to assess strength, fatigue levels Fatigue Severity Scale will be used to evaluate.
- Being tested
- Evaluation
- Keywords
- COPD (Chronic Obstructive Pulmonary Disease), fragility, geriatric
- 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.
EvaluationOther
Modified Medical research Council , Saint George Respiratory Two Minute Walk Test,Frail fragility scale ,Prisma-7 Vulnerability scale,Pase,Berg balance scale,manual muscle test,quadriceps muscle strength, hand dynamometer,Fatigue Severity Scale
| Study group | Role | What they receive |
|---|---|---|
| Fragile elderly individuals with COPD | Patient evaluation form and socio-demographic form of all individuals participating in the study.
properties will be questioned.To assess pulmonary functions at the assessment stage for all individuals pulmonary function test,Modified Medical Questionnaire to assess dyspnea research Council, to assess health-related quality of life, Saint George Respiratory Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect fragility, Prisma-7 Vulnerability scale to assess fragility The scale is Pase to assess physical activity, Berg balance to assess balance. scale, digital hand dynamometer to evaluate quadriceps muscle strength, hand grip strength hand dynamometer to assess fatigue levels Fatigue Severity Scale will be used. Receives: Other: Evaluation | |
| Non-fragile elderly individuals with COPD | Patient evaluation form and socio-demographic form of all individuals participating in the study.
properties will be questioned.To assess pulmonary functions at the assessment stage for all individuals pulmonary function test,Modified Medical Questionnaire to assess dyspnea research Council, to assess health-related quality of life, Saint George Respiratory Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect fragility, Prisma-7 Vulnerability scale to assess fragility The scale is Pase to assess physical activity, Berg balance to assess balance. scale, digital hand dynamometer to evaluate quadriceps muscle strength, hand grip strength hand dynamometer to assess fatigue levels Fatigue Severity Scale will be used. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale(BDO)
The Berg balance scale (BDO) is a scale with 14 instructions and a score of 0-4 for each instruction by observing the patient's performance. 0 points are given when the patient is unable to perform the activity at all, while 4 points are given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating a balance disorder, 21-40 points indicating the presence of an acceptable balance, and 41-56 points indicating the presence of a good balance.
Measured: eight months
Two-minute walk Test
It is recommended that the area where the test will be performed is a corridor with a flat and hard floor of 30 meters long. The goal is to walk the maximum distance he can walk in 2 minutes if he has a helper device he uses. If you have shortness of breath or fatigue, you are told to slow down and stop and then start again when you feel ready.
Measured: eight months
Physical activity scale for the elderly (PASE)
The survey assesses the physical activity of older individuals over the past week and includes components of leisure, housework, and work-related physical activity. Never, rarely (1-2 days/week), sometimes (3-4 days/week) and often (5-7 days/week), while the duration of activities is classified as: Less than 1 hours, 1-2 hours to 2-4 hours and more than 4 hours.
Measured: eight months
Saint George Respiratory Survey
A test that assesses health-related quality of life specific to individuals with respiratory diseases. questions 50 items divided into 3 areas: symptoms (8 items), activities (16 items), effects of the disease (26 items). The 3 sections of the test are scored separately and the total score is calculated. The scores vary from 0-100-0. A score of zero indicates normal and a score of 100 indicates the worst state of health.
Measured: eight months
Modified Medical Research Council scale(MMRC)
The MMRC (modified Medical Research Council scale) is a scale scored between 0 and 4 based on various factors that produce a dyspnea sensation. Zero points only shorten my breath during heavy exercise; 4 points I can't leave the house because of my shortness of breath or I have shortness of breath while getting dressed and undressed
Measured: eight months
Frail fragility scale
Proven to be an effective method of vulnerability detection. The patient's fatigue status, resistance, mobility, weight loss and other diseases were questioned and allowed to evaluate. The FRAIL scale, which consists of 5 items, scores 0 1-2 or 1 based on the patients' response and is evaluated as non-frail, 0 points pre-frail and >2 points fragile.
Measured: eight months
Secondary outcomes (5)
Breathing function test
Spirometry shows the maximum volume of air expelled by the challenging expiration (challenging vital capacity, FVC) from the maximum inspiration point and the volume of air expelled in the first second of this manoeuvre (1. The challenging expiration volume per second, FEV 1) should be measured and these two measurement ratios (FEV 1/FVC) should be calculated. Patients with COPD typically have both FEV 1 and FVC low. When FEV 1/FVC < 70%, the postbronchodilator indicates the presence of a non-fully reversible airflow limitation when FEV 1 < 80% of what is expected.
Measured: eight months
Prisma-7 Vulnerability scale
The PRISMA-7 vulnerability scale is a seven-question survey recommended by the British Geriatric Association as a first-degree screening test. The questions are answered in a yes/no way.
Measured: eight months
hand dynamometer
During the test, the patient sits in a sitting position in shoulder adduction, elbow in 90° flexion, forearm in neutral position, and measurements are performed three repetitions for the right and left sides. It is recorded in kg or pounds as a unit. The norm values for the measurement are 47-40 kg for men aged 20-69 years (2 kg less for the left hand) and 30-24 kg for women (1,5-2 kg less for the left hand).
Measured: eight months
digital hand dynamometer
For quadriceps strength measurement, the test is started when elderly people sit on a flat surface with their hips and knees in 90° flexion and feet in a free, unsupported position. During the test, the "make test" technique, which requires isometric contraction, is applied. All measurements are taken by the same researcher twice from both legs of the participants with the same hand.
Measured: eight months
Fatigue Severity Scale
Evaluates fatigue severity with 9 questions and scores are taken from 9 to 63 on the scale. Each question is scored between 0 (I do not agree at all) and 7 (I totally agree). A high score indicates increased fatigue intensity.
Measured: eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start15 Dec 2022
- Primary completion15 Jan 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Other
- Enrolment
- 54 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral SERTEL, Kırıkkale University
- Investigators
- Yasemin Köse, Principal investigator, Master of Science studentDöndü Nur Keskin, Principal investigator, Master of Science studentİlayda Karabayır, Principal investigator, Master of Science studentMeral Sertel, Study director, Associate professor lecturerSelma Demir, Principal investigator, Specialist doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811832
- Sponsor's protocol ID
- KirikkaleUniversity771
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 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
- Evaluation of Balance, Physical Activity, Functional Capacity and Activities of Daily Living in Frail Elderly Individuals with COPD
- ClinicalTrials.gov ID
- NCT05811832
- Acronym / sponsor ID
- KirikkaleUniversity771
- Keywords
- COPD (Chronic Obstructive Pulmonary Disease), fragility, geriatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 13 Apr 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.
This study is conducted on the evaluation of balance, physical activity, functional capacity and activities of daily living in frail elderly individuals with COPD.
Detailed description
Patient evaluation form and socio-demographic form of all individuals participating in the study. Characteristics will be questioned: Name-surname, address, telephone, age, gender, weight, height, body mass index, occupation, marital status, social security, any systemic other than COPD whether he has a disease, whether he has social security, whether he smokes, It will be questioned whether there is any other COPD patient in the family and whether there is pain. To assess pulmonary functions at the assessment stage for all individuals pulmonary function test to evaluate dyspnea Modified Medical Saint George Respiratory Research Council to assess health-related quality of life Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect frailty, Prisma-7 Vulnerability scale to assess fragility The scale was Pase to assess physical activity, Berg Balance to assess balance scale, digital hand dynamometer to assess quadriceps muscle strength, hand grip hand dynamometer to assess strength, fatigue levels Fatigue Severity Scale will be used to evaluate.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fragile elderly individuals with COPD | – | Other: EvaluationPatient evaluation form and socio-demographic form of all individuals participating in the study. properties will be questioned.To assess pulmonary functions at the assessment stage for all individuals pulmonary function test,Modified Medical Questionnaire to assess dyspnea research Council, to assess health-related quality of life, Saint George Respiratory Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect fragility, Prisma-7 Vulnerability scale to assess fragility The scale is Pase to assess physical activity, Berg balance to assess balance. scale, digital hand dynamometer to evaluate quadriceps muscle strength, hand grip strength hand dynamometer to assess fatigue levels Fatigue Severity Scale will be used. |
| Non-fragile elderly individuals with COPD | – | Other: EvaluationPatient evaluation form and socio-demographic form of all individuals participating in the study. properties will be questioned.To assess pulmonary functions at the assessment stage for all individuals pulmonary function test,Modified Medical Questionnaire to assess dyspnea research Council, to assess health-related quality of life, Saint George Respiratory Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect fragility, Prisma-7 Vulnerability scale to assess fragility The scale is Pase to assess physical activity, Berg balance to assess balance. scale, digital hand dynamometer to evaluate quadriceps muscle strength, hand grip strength hand dynamometer to assess fatigue levels Fatigue Severity Scale will be used. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly individuals aged 65-84 years diagnosed with COPD who are frail or non-fragile.
Key inclusion criteria (5 listed)
- Being diagnosed with COPD according to the Gold criteria
- Be over 65 years old
- Volunteering to participate in the study
- Not having mental and communication problems that prevent filling out the questionnaires to be used in the research.
- Not having an attack in the last 2 months
Key exclusion criteria (8 listed)
- Being in a COPD exacerbation process
- Having been diagnosed with a physical and mental illness
- Having unstable COPD
- Unstabile angina, previous Myocardial Infractus, uncontrolled hypertension, cancer, with functional limitations concomitant neurological or musculoskeletal disorders
- Currently addicted to alcohol or drugs
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 |
|---|---|---|
| EvaluationModified Medical research Council , Saint George Respiratory Two Minute Walk Test,Frail fragility scale ,Prisma-7 Vulnerability scale,Pase,Berg balance scale,manual muscle test,quadriceps muscle strength, hand dynamometer,Fatigue Severity Scale | Other | Fragile elderly individuals with COPD, Non-fragile elderly individuals with COPD |
Primary outcome
Berg balance scale(BDO)
Time frame: eight months
The Berg balance scale (BDO) is a scale with 14 instructions and a score of 0-4 for each instruction by observing the patient's performance. 0 points are given when the patient is unable to perform the activity at all, while 4 points are given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating a balance disorder, 21-40 points indicating the presence of an acceptable balance, and 41-56 points indicating the presence of a good balance.
Two-minute walk Test
Time frame: eight months
It is recommended that the area where the test will be performed is a corridor with a flat and hard floor of 30 meters long. The goal is to walk the maximum distance he can walk in 2 minutes if he has a helper device he uses. If you have shortness of breath or fatigue, you are told to slow down and stop and then start again when you feel ready.
Physical activity scale for the elderly (PASE)
Time frame: eight months
The survey assesses the physical activity of older individuals over the past week and includes components of leisure, housework, and work-related physical activity. Never, rarely (1-2 days/week), sometimes (3-4 days/week) and often (5-7 days/week), while the duration of activities is classified as: Less than 1 hours, 1-2 hours to 2-4 hours and more than 4 hours.
Saint George Respiratory Survey
Time frame: eight months
A test that assesses health-related quality of life specific to individuals with respiratory diseases. questions 50 items divided into 3 areas: symptoms (8 items), activities (16 items), effects of the disease (26 items). The 3 sections of the test are scored separately and the total score is calculated. The scores vary from 0-100-0. A score of zero indicates normal and a score of 100 indicates the worst state of health.
Modified Medical Research Council scale(MMRC)
Time frame: eight months
The MMRC (modified Medical Research Council scale) is a scale scored between 0 and 4 based on various factors that produce a dyspnea sensation. Zero points only shorten my breath during heavy exercise; 4 points I can't leave the house because of my shortness of breath or I have shortness of breath while getting dressed and undressed
Frail fragility scale
Time frame: eight months
Proven to be an effective method of vulnerability detection. The patient's fatigue status, resistance, mobility, weight loss and other diseases were questioned and allowed to evaluate. The FRAIL scale, which consists of 5 items, scores 0 1-2 or 1 based on the patients' response and is evaluated as non-frail, 0 points pre-frail and >2 points fragile.
5 secondary outcomes
Breathing function test
Time frame: eight months
Prisma-7 Vulnerability scale
Time frame: eight months
hand dynamometer
Time frame: eight months
digital hand dynamometer
Time frame: eight months
Fatigue Severity Scale
Time frame: eight months
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
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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.
Yasemin Köse principal investigator
Master of Science student
Döndü Nur Keskin principal investigator
Master of Science student
İlayda Karabayır principal investigator
Master of Science student
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 (Chronic Obstructive Pulmonary Disease), 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 8 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?
Berg balance scale(BDO) (time frame: eight months). The study lists 6 primary outcomes in all. 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.