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

June 24, 2026 updated by: Aslihan Cakmak-Onal, Hacettepe University

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation
        • Contact:
        • Principal Investigator:
          • Aslihan Cakmak-Onal, PhD, PT
        • Sub-Investigator:
          • Elif Kocaaga, MSc, PT
        • Sub-Investigator:
          • Deniz Inal-Ince, PhD, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals with COPD and Healthy Controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
COPD
Individuals with stable COPD
Other: No intervention
No intervention
Healthy Individuals
Healthy controls
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: 1st day
Functional capacity assessment using self-paced 6-minute walk test.
1st day
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.
1st day
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.
1st day
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.
1st day
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.
1st day
Functional exercise capacity
Time Frame: 1st day
One-minute sit to stand test will be performed. The number of repetitions will be recorded.
1st day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Forced vital capacity
Time Frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
1st day
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.
1st day
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.
1st day
Peak expiratory flow
Time Frame: 1st day
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
1st day
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.
1st day
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.
1st day
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.
1st day
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.
1st day
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.
1st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aslihan Cakmak-Onal, PhD, PT, Hacettepe University
  • Study Director: Deniz Inal-Ince, PhD, PT, Hacettepe University
  • Principal Investigator: Elif Kocaaga, MSc, PT, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBA24/414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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