DyslipidemiasNCT06563154
Are Exercise Capacity and Physical Fitness Related With Quality of Life, Physical Activity, Cognitive Health and Health Literacy in Dyslipidemia
An observational study of Dyslipidemias, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Exercise Capacity Assessment, Physical Fitness Assessment and Quality of Life Assessment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dyslipidemia
Who may be able to join
- Being followed up with a diagnosis of dyslipidemia,
- Being between the ages of 18-65,
- Being willing to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyslipidemias
- Being tested
- Exercise Capacity Assessment, Physical Fitness Assessment, Quality of Life Assessment, Physical Activity Assessment, Cognitive Health Assessment
- Keywords
- Dyslipidemia, Exercise Capacity, Physical Fitness, Cognitive Health, Physical Activity, Health Literacy
- Medical subject headings
- Dyslipidemias, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Capacity AssessmentDiagnostic test
To examine the relationship between exercise capacity and physical fitness of dyslipidemia patients and quality of life, cognitive status and health literacy.
Physical Fitness AssessmentDiagnostic test
- 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.
Quality of Life AssessmentOther
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.
Physical Activity AssessmentOther
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.
Cognitive Health AssessmentOther
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.
Health Literacy AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Not described Receives: Diagnostic Test: Exercise Capacity Assessment; Diagnostic Test: Physical Fitness Assessment; Other: Quality of Life Assessment; Other: Physical Activity Assessment; Other: Cognitive Health Assessment; Other: Health Literacy Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Measured: First Day
Physical Fitness
Measured: Second Day
Secondary outcomes (4)
Physical Activity
Measured: Second Day
Quality of Life Assessment
Measured: Second Day
Cognitive Health
Measured: Second Day
Health Literacy
Measured: Second Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start20 Aug 2024
- Primary completion15 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Furkan Özdemir, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563154
- Sponsor's protocol ID
- 03-01-2023-4
- Status last verified
- Jan 2025
- First submitted
- 17 Aug 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozdemir F, Saglam M, Uyaroglu OA, Vardar Yagli N. Impact of physical activity, health literacy and cognitive health on quality of life in dyslipidemia: an observational study. Sci Rep. 2025 Oct 13;15(1):35586. doi: 10.1038/s41598-025-02223-4.
PubMed 41083504
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06563154
- Acronym / sponsor ID
- 03-01-2023-4
- Conditions
- Dyslipidemias
- Keywords
- Dyslipidemia, Exercise Capacity, Physical Fitness, Cognitive Health, Physical Activity, Health Literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Diagnostic Test: Exercise Capacity Assessment, Diagnostic Test: Physical Fitness Assessment, Other: Quality of Life Assessment, Other: Physical Activity Assessment, Other: Cognitive Health Assessment, Other: Health Literacy Assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dyslipidemia
Key inclusion criteria (3 listed)
- Being followed up with a diagnosis of dyslipidemia,
- Being between the ages of 18-65,
- Being willing to participate in the study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Capacity AssessmentTo examine the relationship between exercise capacity and physical fitness of dyslipidemia patients and quality of life, cognitive status and health literacy. | Diagnostic test | Patient Group |
| 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. | Diagnostic test | Patient Group |
| Quality of Life AssessmentParticipants' 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 | Patient Group |
| Physical Activity AssessmentParticipants' 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 | Patient Group |
| Cognitive Health AssessmentParticipants' 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 | Patient Group |
| Health Literacy AssessmentParticipants' 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. | Other | Patient Group |
Primary outcome
Exercise Capacity
Time frame: First Day
Physical Fitness
Time frame: Second Day
4 secondary outcomes
Physical Activity
Time frame: Second Day
Quality of Life Assessment
Time frame: Second Day
Cognitive Health
Time frame: Second Day
Health Literacy
Time frame: Second Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 41083504Ozdemir F, Saglam M, Uyaroglu OA, Vardar Yagli N. Impact of physical activity, health literacy and cognitive health on quality of life in dyslipidemia: an observational study. Sci Rep. 2025 Oct 13;15(1):35586. doi: 10.1038/s41598-025-02223-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Capacity (time frame: First Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.