Evaluation in Individuals with COPD and Asymptomatic Individuals

NCT06077357 | Completed

• 1 other identifier: KU-FTR-IK-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pain; Muscle Strength; Kinesiophobia

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (5)

• The Physical Activity Scale for the Elderly (PASE)

  4 months

• The Tampa Scale of Kinesiophobia

  4 months

• Hand Grip Strength Measurement

  4 months

• PRISMA-7 Fragility Test

  4 months

• The Mini Mental Test (MMT)

  4 months

Study Arms (2)

COPD Patients

ACTIVE COMPARATOR

Having COPD. Older than 65 years old and not having any communication problems.

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.

Other: MMSE Test; Other: PASE Test; Other: The PRISMA-7 Frailty Scale; Other: TAMPA Test; Other: (JAMAR) Muscle Test; Other: Fatigue Severity Scale

Interventions

MMSE Test OTHER

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.

Asymptomatic Patients; COPD Patients

PASE Test OTHER

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.

Asymptomatic Patients; COPD Patients

The PRISMA-7 Frailty Scale OTHER

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.

Asymptomatic Patients; COPD Patients

TAMPA Test OTHER

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.

Asymptomatic Patients; COPD Patients

(JAMAR) Muscle Test OTHER

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.

Asymptomatic Patients; COPD Patients

Fatigue Severity Scale OTHER

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.

Asymptomatic Patients; COPD Patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale Yuksek Ihtisas Hospital

Kırıkkale, Yahsihan, 71100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Meral SERTEL, Doc.Dr.

  Kırıkkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR DOCTOR

Model Details: Two groups consisting of a COPD group and an Asymptomatic group.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 11, 2023
• Study Start: January 21, 2023
• Primary Completion: January 21, 2023
• Study Completion: September 21, 2023
• Last Updated: October 15, 2024

Record last verified: 2023-10

Locations

TU (1)