Back to resultsEvaluation in Individuals With COPD and Asymptomatic Individuals
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MMSE Test
PASE Test
The PRISMA-7 Frailty Scale
TAMPA Test
(JAMAR) Muscle Test
Fatigue Severity Scale
Sponsored by
About this trial
This is an interventional screening trial for Chronic Obstructive Pulmonary Disease focused on measuring Pain, Muscle Strength, Kinesiophobia
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for COPD Patients: 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 Inclusion Criteria for Asymptomatic Individuals: 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 Exclusion Criteria: Exclusion Criteria for COPD and Asymptomatic Individuals: 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.
Sites / Locations
- Kırıkkale Yuksek Ihtisas Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
COPD Patients
Asymptomatic Patients
Arm Description
Having COPD. Older than 65 years old and not having any communication problems.
Not having a diagnosis of COPD and being over 65 years old and not having any communication problems.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT06077357
First Posted
September 25, 2023
Last Updated
October 8, 2023
Sponsor
Kırıkkale University
1. Study Identification
Unique Protocol Identification Number
NCT06077357
Brief Title
Evaluation in Individuals With COPD and Asymptomatic Individuals
Official Title
Evaluation of Frailty, Hand Grip Strength, Physically Activity, Kinesiophobia and Fatigue in Chronic Obstructive Pulmonary Disease and Asymptomatic Geriatric Individual
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
January 21, 2023 (Actual)
Study Completion Date
September 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pain, Muscle Strength, Kinesiophobia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups consisting of a COPD group and an Asymptomatic group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD Patients
Arm Type
Active Comparator
Arm Description
Having COPD. Older than 65 years old and not having any communication problems.
Arm Title
Asymptomatic Patients
Arm Type
Active Comparator
Arm Description
Not having a diagnosis of COPD and being over 65 years old and not having any communication problems.
Intervention Type
Other
Intervention Name(s)
MMSE Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PASE Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The PRISMA-7 Frailty Scale
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TAMPA Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
(JAMAR) Muscle Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fatigue Severity Scale
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Fatigue Severity Scale
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
The Physical Activity Scale for the Elderly (PASE)
Description
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.
Time Frame
4 months
Title
The Tampa Scale of Kinesiophobia
Description
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.
Time Frame
4 months
Title
Hand Grip Strength Measurement
Description
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.
Time Frame
4 months
Title
PRISMA-7 Fragility Test
Description
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.
Time Frame
4 months
Title
The Mini Mental Test (MMT)
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria for COPD Patients:
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
Inclusion Criteria for Asymptomatic Individuals:
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
Exclusion Criteria:
Exclusion Criteria for COPD and Asymptomatic Individuals:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meral SERTEL, Doc.Dr.
Organizational Affiliation
Kırıkkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırıkkale Yuksek Ihtisas Hospital
City
Kırıkkale
State/Province
Yahsihan
ZIP/Postal Code
71100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Evaluation in Individuals With COPD and Asymptomatic Individuals
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