Clinical trial NCT06077357: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pain
Muscle Strength
Kinesiophobia
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups consisting of a COPD group and an Asymptomatic group.
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: The Fatigue Severity Scale
timeFrame: 4 months
Secondary outcomes:
measure: The Physical Activity Scale for the Elderly (PASE)
timeFrame: 4 months
measure: The Tampa Scale of Kinesiophobia
timeFrame: 4 months
measure: Hand Grip Strength Measurement
timeFrame: 4 months
measure: PRISMA-7 Fragility Test
timeFrame: 4 months
measure: The Mini Mental Test (MMT)
timeFrame: 4 months
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale Yuksek Ihtisas Hospital
state: Yahsihan
Study officials:
affiliation: Kırıkkale University
name: Meral SERTEL, Doc.Dr.
role: PRINCIPAL_INVESTIGATOR
References: