- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06563154
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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 Locations
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Patient Group
|
To examine the relationship between exercise capacity and physical fitness of dyslipidemia patients and quality of life, cognitive status and health literacy.
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.
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.
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.
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
Outcome Measure |
Time Frame |
|---|---|
|
Exercise Capacity
Time Frame: First Day
|
First Day
|
|
Physical Fitness
Time Frame: Second Day
|
Second Day
|
Secondary Outcome Measures
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
Collaborators
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)
August 20, 2024
Primary Completion (Actual)
December 15, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
August 17, 2024
First Submitted That Met QC Criteria
August 17, 2024
First Posted (Actual)
August 20, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 9, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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