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Clinical Trials/NCT06497816
NCT06497816RecruitingNot Applicable

An Investigation of Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in Chronic Obstructive Pulmonary Disease and Healthy Individuals

Hacettepe University2 sites in 2 countries144 target enrollmentStarted: June 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
144
Locations
2
Primary Endpoint
Cognitive function

Study Overview

Brief Summary

Health literacy is important for controlling disease progression and living a healthy life with illness. High health literacy is associated with higher cognitive performance and lower health-related quality of life. Physical, psychological, and social impairments are seen in chronic obstructive pulmonary disease (COPD). Studies investigating the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD are limited. Therefore, the aim of this study was to compare individuals with COPD with healthy individuals in terms of health literacy, functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living and to investigate the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • for the COPD group:
  • Being over 40 years old,
  • Diagnosed with COPD and being clinically stable,
  • Being able to cooperate with the tests to be performed,
  • Not having any cardiovascular disease, orthopedic or neurological problems that may affect the tests,
  • Being willing to participate in the study.

Exclusion Criteria

  • for the COPD group:
  • Being in an acute exacerbation period,
  • Having any cardiovascular disease, orthopedic or neurological problems that may affect the tests,
  • Not being willing to participate in the study.
  • Inclusion criteria for the control group:
  • Being willing to participate in the study and being over 40 years old
  • Not having any known disease
  • Exclusion criteria for the control group:
  • Not being able to cooperate with the tests to be performed
  • Not being willing to participate in the study

Outcomes

Primary Outcomes

Cognitive function

Time Frame: 1st day

Montreal Cognitive Assessment will be used to evaluate cognitive function. The Montreal Cognitive Assessment scores range between 0 and 30. A score of 26 or over is considered to be normal.

Health literacy

Time Frame: 1st day

Test of Functional Health Literacy in Adults will be used to evaluate health literacy. The TOFHLA is scored on a scale of 0 to 100 and higher scores indicate higher health literacy.

Functional capacity

Time Frame: 1st day

Functional capacity assessment using self-paced 6-minute walk test.

Functional exercise capacity

Time Frame: 1st day

One-minute sit to stand test will be performed. The number of repetitions will be recorded.

Health-related behavior

Time Frame: 1st day

Health-related Behavior Scale II will be performed to assess health-related behavior. The Health-related Behavior Scale II measures various health-related behaviors and is designed to assess the frequency or extent of engagement in these behaviors. Higher scores of the scale indicate more frequent or healthier behaviors, depending on the specific behavior being measured.

Secondary Outcomes

  • Activities of daily living(1st day)
  • Forced expiratory volume in one second(1st day)
  • forced expiratory volume in one second/forced vital capacity ratio(1st day)
  • Peak expiratory flow(1st day)
  • Forced vital capacity(1st day)
  • Forced mid-expiratory flow (FEF25-75)(1st day)
  • Physical activity level(1st day)
  • Assessment of quality of life(1st day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aslihan Cakmak-Onal

Principal Investigator

Hacettepe University

Study Sites (2)

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