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NCT Number: NCT06497816

Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Aslihan Cakmak-Onal, PhD, PT

CONTACT

[email protected]

03123051576 ext. 178

Aslihan Cakmak-Onal, PhD, PT

PRINCIPAL_INVESTIGATOR

Deniz Inal-Ince, PhD, PT

SUB_INVESTIGATOR

Elif Kocaaga, MSc, PT

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Functional capacity

    Time frame: 1st day

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

  2. 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.

  3. Health literacy

    Time frame: 1st day

    The Rapid Estimate of Adult Literacy in Medicine questionnaires will be performed. A score of 59 or less is defined as indicating low health literacy and a score of 60 or more indicates adequate health literacy.

  4. 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.

  5. 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.

  6. Functional exercise capacity

    Time frame: 1st day

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

Secondary outcomes

  1. Forced vital capacity

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.

  2. Forced expiratory volume in one second

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.

  3. forced expiratory volume in one second/forced vital capacity ratio

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.

  4. Peak expiratory flow

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.

  5. Forced mid-expiratory flow (FEF25-75)

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.

  6. Physical activity level

    Time frame: 1st day

    Physical activity will be evaluated with International Physical Activity Questionnaire questionnaire. The questionnaire assesses physical activity across different domains, including leisure time, domestic and gardening activities, work-related activities, and transport-related activities. Scores are calculated based on the duration (minutes) and frequency (days) of these activities over the past seven days. Higher scores on the IPAQ indicate a higher level of physical activity.

  7. Assessment of quality of life

    Time frame: 1st day

    St. George quality of life questionnaire will be used to assess quality of life. Higher scores reflect worse health status.

  8. Activities of daily living

    Time frame: 1st day

    Activities of daily living will be evaluated using Leicester Cough Questionnaire. Each question is scored on a scale from 1 (maximum impact) to 7 (minimal impact). An average score is calculated for each domain (physical, psychological, and social), resulting in scores ranging from 1 to 7 per domain, and a total score between 3 and 21. A higher score indicates less impact.

  9. Assessment of quality of life

    Time frame: 1st day

    Short Form-36 will be applied for assessing quality of life. Higher scores indicate better health status.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslihan Cakmak-Onal, PhD, PT

CONTACT

[email protected]

03123051576 ext. 178

Elif Kocaaga, MSc, PT

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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