Are Exercise Capacity and Physical Fitness Related With Quality of Life, Physical Activity, Cognitive Health and Health Literacy in Dyslipidemia

January 9, 2025 updated by: Furkan Özdemir, Çankırı Karatekin University

Investigation of the Relationship Between Exercise Capacity, Physical Fitness, Quality of Life, Physical Activity Level, Cognitive Status and Health Literacy in Individuals Diagnosed With Dyslipidemia

There is insufficient literature explaining the relationship between exercise capacity and physical fitness of dyslipidemia patients and quality of life, cognitive status and health literacy. Our aim with this study is to provide more information to the scientific literature about the relationship between exercise capacity and physical fitness and quality of life and health literacy in dyslipidemia patients.

Study Overview

Status

Status

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

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.

Detailed Description

Lipid profile disorders (especially high total blood cholesterol levels) are considered a significant public health problem worldwide and it is reported that approximately one in three people are exposed to risk factors that can lead to dyslipidemia. Prevalence studies conducted worldwide show that lipid profile disorders vary between 6.9% and 43.6%. Today, ischemic heart and central nervous system diseases are reported to be the most important causes of mortality and morbidity in the adult population globally. It is accepted that lipid profile disorders are the leading risk factors that cause ischemic heart diseases in particular. Since lipid profile disorders are caused by many different genetic and environmental factors, their incidence varies according to regions, lifestyle habits and individual factors. Apart from individual factors, lipid weight in the diet and lack of other nutrients that balance lipid metabolism, physical activity level and inactivity, other existing comorbid diseases and medical treatments change lipid metabolism in individuals and may lead to deterioration in lipid profile. In particular, lifestyle habits are the most easily modifiable factors that affect lipid metabolism. Studies conducted to evaluate the effect of genetic factors have shown that blood lipid levels are generally higher in Caucasians (especially total plasma cholesterol), that plasma high-density lipoprotein (HDL) levels are lower in East-Southeast Asian societies, and that plasma lipid density is generally lower in Hispanic societies. These studies have also indicated that these differences in lipid profiles are seen in the ethnic group examined in isolation when compared to other ethnic groups living in the same region, and therefore that dyslipidemia also has a genetic origin. It is recommended to follow multifaceted approaches when treating lipid profile disorders. Dietary counseling and exercise therapy are generally recommended to be included in these approaches. Exercise therapy is considered a very important treatment option, especially for controlling and treating obesity, hypertension, hyperglycemia, and metabolic syndrome symptoms that may accompany dyslipidemia. Physical activity is defined as body movements that create skeletal muscle contraction and increase energy expenditure. Exercise is a specialized type of physical activity that focuses on working specific muscle groups within a structured program for a specific purpose. Physical activity and exercise are beneficial for health and have a positive effect on psychological function, quality of life, morbidity, and cardiorespiratory fitness. Physical activity and exercise also increase self-esteem and social participation, while reducing depression and other related mental symptoms.

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 (Actual)

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.
65

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
      • Ankara, Turkey
        • Hacettepe University

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

No

Sampling Method

Probability Sample

Study Population

Patients with dyslipidemia

Description

Inclusion Criteria:

  • Being followed up with a diagnosis of dyslipidemia,
  • Being between the ages of 18-65,
  • Being willing to participate in the study.

Exclusion Criteria:

  • Having an orthopedic, neurological, cardiac, pulmonary or rheumatological disease that may affect functional capacity,
  • Having a psychiatric disorder that may affect cooperation,
  • Refusing 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.
Patient Group
Diagnostic test: Exercise Capacity Assessment
To examine the relationship between exercise capacity and physical fitness of dyslipidemia patients and quality of life, cognitive status and health literacy.
Diagnostic test: Physical Fitness Assessment
  • 1-Minute Sit-to-Stand Test: Participants will be asked to sit down and stand up for 1 minute without pausing, and the repetition number will be recorded.
  • Timed Up-and-Go Test: Participants will be asked to get up, walk a distance of 3 meters, return and sit down again. The time spent during this track will be recorded.
  • Peripheral muscle strength assessment: Participants will be asked to resist the resistance by producing maximum isometric force during the movement, and the maximal force will be evaluated with a dynamometer. The quadriceps femoris muscle, shoulder abductor muscles and hand grip strength will be used for the assessment.
  • Flexibility assessment: Participants will be asked to reach towards the tips of their toes while sitting. During this time, the distance between the participant's fingertips and toes will be measured.
Other: Quality of Life Assessment
Participants' quality of life will be assessed with the Turkish version of the Short Form Quality of Life Questionnaire (SF-36). The questionnaire consists of 36 questions that examine quality of life from different perspectives. It examines quality of life in the subcategories of physical function, physical role difficulty, pain, general health, vitality (energy), social function, emotional role difficulty and mental health. The score for each category varies between 0-100, with a high score indicating a good quality of life.
Other: Physical Activity Assessment
Participants' physical activity level will be assessed with the Turkish version of the International Physical Activity Scale - Short Form (IPAQ-SF). The IPAQ-SF evaluates the physical activities of the participants in the last 7 days based on sitting time, walking time, moderate and vigorous physical activities.
Other: Cognitive Health Assessment
Participants' cognitive health will be assessed with the with the Turkish version of the Mini Mental State Examine (MMSE). The test is scored between 0-30. Scores of 25 and above are considered normal. A total score of less than 10 indicates severe impairment. Scores between 10-19 indicate moderate dementia. Scores between 19-24 indicate early dementia.
Other: Health Literacy Assessment
Participants' health literacy will be assessed with the Turkish version of the HLS-EU-47 health literacy survey. The survey consists of 47 questions. Each item is assessed with one of the following options: Very difficult (1), difficult (2), easy (3), very easy (4) and I don't know. A high total score indicates good health literacy. A total score of 0-25 points indicates insufficient health literacy, >25-33: problematic - limited health literacy, >33-42: sufficient health literacy, >42-50: excellent health literacy.

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
Time Frame
Exercise Capacity
Time Frame: First Day
First Day
Physical Fitness
Time Frame: Second Day
Second 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
Time Frame
Physical Activity
Time Frame: Second Day
Second Day
Quality of Life Assessment
Time Frame: Second Day
Second Day
Cognitive Health
Time Frame: Second Day
Second Day
Health Literacy
Time Frame: Second Day
Second 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.
Çankırı Karatekin University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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.
August 20, 2024

Primary Completion (Actual)

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.
December 15, 2024

Study Completion (Actual)

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.
December 30, 2024

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).
August 17, 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.
August 17, 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.
August 20, 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.
March 25, 2025

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.
January 9, 2025

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.
January 1, 2025

More Information

Terms related to this study

Keywords

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.
  • 03-01-2023-4

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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