Chronic Obstructive Pulmonary DiseaseNCT06077357
Evaluation in Individuals with COPD and Asymptomatic Individuals
A study testing MMSE Test, PASE Test and The PRISMA-7 Frailty Scale in people with Chronic Obstructive Pulmonary Disease, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The literature does not provide sufficient information on the evaluation of frailty, handgrip strength, physical activity, kinesiophobia, and fatigue in elderly individuals with Chronic Obstructive Pulmonary Disease and asymptomatic elderly individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MMSE Test, PASE Test and The PRISMA-7 Frailty Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2023to 21 Sep 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Having received a diagnosis of COPD
- Being 65 years of age or older
- Volunteering to participate in the study
- Not having any mental or communication issues that would hinder the completion of the questionnaires to be used in the research
- Not having received a diagnosis of COPD
- Being 65 years of age or older
- Volunteering to participate in the study
- Not having any mental or communication issues that would hinder the completion of the questionnaires to be used in the research
Who cannot join
- Having a diagnosis of both physical and mental illnesses
- Being diagnosed with unstable COPD
- Having conditions such as unstable angina, prior heart attack, uncontrolled hypertension, cancer, and neurological disorders accompanied by functional limitations
- Currently being addicted to alcohol or substances
- Having severe visual and hearing impairments
- Having undergone major surgery in the past few months
- Having a history of recurring significant clinical infections.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale Yuksek Ihtisas Hospital
Kirikkale, Yahsihan, 71100
About this study
Official title: Evaluation of Frailty, Hand Grip Strength, Physically Activity, Kinesiophobia and Fatigue in Chronic Obstructive Pulmonary Disease and Asymptomatic Geriatric Individual
The literature does not provide sufficient information on the evaluation of frailty, handgrip strength, physical activity, kinesiophobia, and fatigue in elderly individuals with Chronic Obstructive Pulmonary Disease and asymptomatic elderly individuals. Additionally, there is a gap in the literature regarding the impact of COPD on these parameters in geriatric individuals diagnosed with Chronic Obstructive Pulmonary Disease . To fill this gap in the literature and to establish treatment approaches based on the results of parameters studied in elderly individuals with Chronic Obstructive Pulmonary Disease in future studies.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a prevalent condition among the elderly population, considered a leading cause of morbidity and mortality. It is characterized by chronic inflammatory responses associated with harmful particles or gases in the airways and lungs, resulting in persistent airflow limitation that is both preventable and treatable . While cough and sputum are reported as clinical symptoms in COPD cases, the most prominent clinical symptom is dyspnea. Age-related physiological changes and frailty lead to a decrease in levels of physical activity. The resulting deconditioning from reduced physical activity causes a decline in ventilation quality, creating a vicious cycle that progressively exacerbates dyspnea. This study involves the comparison of individuals diagnosed with COPD with asymptomatic geriatric individuals. Its aim is to examine the effects of COPD on frailty, handgrip strength, physical activity, kinesiophobia, and fatigue.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- MMSE Test, PASE Test, The PRISMA-7 Frailty Scale, TAMPA Test, (JAMAR) Muscle Test
- Keywords
- Pain, Muscle Strength, Kinesiophobia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSE TestOther
Mini Mental State Examination (MMSE), is a brief mental test used to assess individuals' cognitive functions. This test evaluates basic cognitive abilities such as memory, attention, calculation, language, orientation, and problem-solving. MMSE is commonly used for monitoring and assessing mild cognitive impairments, dementia, and other neurological conditions. This test is typically scored out of 30, with higher scores indicating better cognitive function.
PASE TestOther
The PASE test stands for "Physical Activity Scale for the Elderly." This scale is used to assess the physical activities undertaken by elderly individuals in their daily lives. The PASE test allows for the evaluation of both daily activities such as walking, climbing stairs, and household chores, as well as exercise routines. It is used to determine the level of physical activity in elderly individuals and support the process of healthy aging.
The PRISMA-7 Frailty ScaleOther
The PRISMA-7 Frailty Scale is a tool used to assess the level of frailty in elderly individuals. This scale evaluates signs of frailty such as physical activity, fatigue, weight loss, and difficulties with vision and hearing. PRISMA-7 is employed in determining the risk of frailty in the elderly and aids in identifying appropriate treatment and support methods.
TAMPA TestOther
The TAMPA test, abbreviated from "Tampa Scale for Kinesiophobia," is a scale used to assess fears related to pain. This scale is employed to evaluate the fear of pain and avoidance behaviors associated with it. By measuring individuals' attitudes and fears towards pain, the TAMPA test helps identify their emotional and behavioral responses in this area.
(JAMAR) Muscle TestOther
The JAMAR Muscle Test is a widely used clinical assessment tool for evaluating hand grip strength. It involves using a device called a dynamometer to measure the force exerted by a person's hand when squeezing the instrument. This test provides valuable information about an individual's upper body strength, which can be important in various medical and rehabilitative contexts. The JAMAR Muscle Test is often utilized in physical therapy, sports medicine, and other healthcare fields.
Fatigue Severity ScaleOther
The Fatigue Severity Scale (FSS) is a self-report questionnaire used to assess the severity of fatigue in individuals. It consists of nine items that measure the impact of fatigue on various aspects of daily life, such as physical functioning, motivation, and mental clarity. The FSS is commonly used in clinical settings and research studies to quantify the level of fatigue experienced by individuals with various medical conditions, including chronic illnesses, neurological disorders, and mental health conditions. It provides valuable information for healthcare professionals in understanding and managing fatigue-related symptoms.
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients | Active comparator | Having COPD. Older than 65 years old and not having any communication problems. Receives: Other: MMSE Test; Other: PASE Test; Other: The PRISMA-7 Frailty Scale; Other: TAMPA Test; Other: (JAMAR) Muscle Test; Other: Fatigue Severity Scale |
| Asymptomatic Patients | Active comparator | Not having a diagnosis of COPD and being over 65 years old and not having any communication problems. Receives: Other: MMSE Test; Other: PASE Test; Other: The PRISMA-7 Frailty Scale; Other: TAMPA Test; Other: (JAMAR) Muscle Test; Other: Fatigue Severity Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fatigue Severity Scale
The Fatigue Severity Scale evaluates the severity of fatigue through 9 questions, with scores ranging from 9 to 63 on the scale. Each question is scored on a 1 (completely disagree) to 7 (completely agree) Likert scale. A higher score indicates increased severity of fatigue.A higher score is worse.
Measured: 4 months
Secondary outcomes (5)
The Physical Activity Scale for the Elderly (PASE)
The questionnaire assesses the physical activities of elderly individuals within the past week, covering components related to leisure, household chores, and work-related physical activities. Participation in leisure-time activities, including outdoor walking of light, moderate, and vigorous intensity, as well as muscle-strengthening exercises, is recorded as never, seldom (1-2 days/week), sometimes (3-4 days/week), and often (5-7 days/week). Additionally, the duration of activities is classified as less than 1 hour, 1-2 hours, 2-4 hours, and more than 4 hours. A higher score indicates higher physical activity levels.A higher score is better.
Measured: 4 months
The Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia is a 17-item checklist. A 4-point scale is used for scoring (1= Strongly Disagree, 4= Strongly Agree). Individuals receive a total score between 17 and 68. A higher score indicates higher levels of kinesiophobia.A higher score is worse.
Measured: 4 months
Hand Grip Strength Measurement
Hand Grip Strength Measurement is a test used to assess upper extremity muscle strength. The test is performed three times on both hands, and the results are recorded. The highest values on both sides are documented. A high score indicates high hand grip strength.
Measured: 4 months
PRISMA-7 Fragility Test
This scale consists of 7 questions. Each question is answered with yes or no. Having more "yes" answers indicates a higher level of frailty. Having 3 or more "yes" answers indicates fragility.A higher score is worse.
Measured: 4 months
The Mini Mental Test (MMT)
This test is conducted for cognitive assessment. Scores range from 0 to 30. A score higher than 24 indicates no cognitive impairment.A higher score is better.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start21 Jan 2023
- Primary completion21 Jan 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups consisting of a COPD group and an Asymptomatic group.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral SERTEL, Kırıkkale University
- Investigators
- Meral SERTEL, Doc.Dr., Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077357
- Sponsor's protocol ID
- KU-FTR-IK-01
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Frailty, Hand Grip Strength, Physically Activity, Kinesiophobia and Fatigue in Chronic Obstructive Pulmonary Disease and Asymptomatic Geriatric Individual
- ClinicalTrials.gov ID
- NCT06077357
- Acronym / sponsor ID
- KU-FTR-IK-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pain, Muscle Strength, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 11 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.
The literature does not provide sufficient information on the evaluation of frailty, handgrip strength, physical activity, kinesiophobia, and fatigue in elderly individuals with Chronic Obstructive Pulmonary Disease and asymptomatic elderly individuals. Additionally, there is a gap in the literature regarding the impact of COPD on these parameters in geriatric individuals diagnosed with Chronic Obstructive Pulmonary Disease . To fill this gap in the literature and to establish treatment approaches based on the results of parameters studied in elderly individuals with Chronic Obstructive Pulmonary Disease in future studies.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a prevalent condition among the elderly population, considered a leading cause of morbidity and mortality. It is characterized by chronic inflammatory responses associated with harmful particles or gases in the airways and lungs, resulting in persistent airflow limitation that is both preventable and treatable . While cough and sputum are reported as clinical symptoms in COPD cases, the most prominent clinical symptom is dyspnea. Age-related physiological changes and frailty lead to a decrease in levels of physical activity. The resulting deconditioning from reduced physical activity causes a decline in ventilation quality, creating a vicious cycle that progressively exacerbates dyspnea. This study involves the comparison of individuals diagnosed with COPD with asymptomatic geriatric individuals. Its aim is to examine the effects of COPD on frailty, handgrip strength, physical activity, kinesiophobia, and fatigue.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups consisting of a COPD group and an Asymptomatic group.
| Arm | Type | Receives |
|---|---|---|
| COPD Patients | Active comparator | Other: MMSE Test, Other: PASE Test, Other: The PRISMA-7 Frailty Scale, Other: TAMPA Test, Other: (JAMAR) Muscle Test, Other: Fatigue Severity ScaleHaving COPD. Older than 65 years old and not having any communication problems. |
| Asymptomatic Patients | Active comparator | Other: MMSE Test, Other: PASE Test, Other: The PRISMA-7 Frailty Scale, Other: TAMPA Test, Other: (JAMAR) Muscle Test, Other: Fatigue Severity ScaleNot having a diagnosis of COPD and being over 65 years old and not having any communication problems. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| MMSE TestMini Mental State Examination (MMSE), is a brief mental test used to assess individuals' cognitive functions. This test evaluates basic cognitive abilities such as memory, attention, calculation, language, orientation, and problem-solving. MMSE is commonly used for monitoring and assessing mild cognitive impairments, dementia, and other neurological conditions. This test is typically scored out of 30, with higher scores indicating better cognitive function. | Other | Asymptomatic Patients, COPD Patients |
| PASE TestThe PASE test stands for "Physical Activity Scale for the Elderly." This scale is used to assess the physical activities undertaken by elderly individuals in their daily lives. The PASE test allows for the evaluation of both daily activities such as walking, climbing stairs, and household chores, as well as exercise routines. It is used to determine the level of physical activity in elderly individuals and support the process of healthy aging. | Other | Asymptomatic Patients, COPD Patients |
| The PRISMA-7 Frailty ScaleThe PRISMA-7 Frailty Scale is a tool used to assess the level of frailty in elderly individuals. This scale evaluates signs of frailty such as physical activity, fatigue, weight loss, and difficulties with vision and hearing. PRISMA-7 is employed in determining the risk of frailty in the elderly and aids in identifying appropriate treatment and support methods. | Other | Asymptomatic Patients, COPD Patients |
| TAMPA TestThe TAMPA test, abbreviated from "Tampa Scale for Kinesiophobia," is a scale used to assess fears related to pain. This scale is employed to evaluate the fear of pain and avoidance behaviors associated with it. By measuring individuals' attitudes and fears towards pain, the TAMPA test helps identify their emotional and behavioral responses in this area. | Other | Asymptomatic Patients, COPD Patients |
| (JAMAR) Muscle TestThe JAMAR Muscle Test is a widely used clinical assessment tool for evaluating hand grip strength. It involves using a device called a dynamometer to measure the force exerted by a person's hand when squeezing the instrument. This test provides valuable information about an individual's upper body strength, which can be important in various medical and rehabilitative contexts. The JAMAR Muscle Test is often utilized in physical therapy, sports medicine, and other healthcare fields. | Other | Asymptomatic Patients, COPD Patients |
| Fatigue Severity ScaleThe Fatigue Severity Scale (FSS) is a self-report questionnaire used to assess the severity of fatigue in individuals. It consists of nine items that measure the impact of fatigue on various aspects of daily life, such as physical functioning, motivation, and mental clarity. The FSS is commonly used in clinical settings and research studies to quantify the level of fatigue experienced by individuals with various medical conditions, including chronic illnesses, neurological disorders, and mental health conditions. It provides valuable information for healthcare professionals in understanding and managing fatigue-related symptoms. | Other | Asymptomatic Patients, COPD Patients |
Primary outcome
The Fatigue Severity Scale
Time frame: 4 months
The Fatigue Severity Scale evaluates the severity of fatigue through 9 questions, with scores ranging from 9 to 63 on the scale. Each question is scored on a 1 (completely disagree) to 7 (completely agree) Likert scale. A higher score indicates increased severity of fatigue.A higher score is worse.
5 secondary outcomes
The Physical Activity Scale for the Elderly (PASE)
Time frame: 4 months
The Tampa Scale of Kinesiophobia
Time frame: 4 months
Hand Grip Strength Measurement
Time frame: 4 months
PRISMA-7 Fragility Test
Time frame: 4 months
The Mini Mental Test (MMT)
Time frame: 4 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.
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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.
Meral SERTEL, Doc.Dr. principal investigator
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMSE Test, PASE Test and The PRISMA-7 Frailty Scale in people with 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 8 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?
The Fatigue Severity Scale (time frame: 4 months). 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.