NCT06563154

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

August 17, 2024

Last Update Submit

January 9, 2025

Conditions

Keywords

DyslipidemiaExercise CapacityPhysical FitnessCognitive HealthPhysical ActivityHealth Literacy

Outcome Measures

Primary Outcomes (2)

  • Exercise Capacity

    First Day

  • Physical Fitness

    Second Day

Secondary Outcomes (4)

  • Physical Activity

    Second Day

  • Quality of Life Assessment

    Second Day

  • Cognitive Health

    Second Day

  • Health Literacy

    Second Day

Study Arms (1)

Patient Group

Diagnostic Test: Exercise Capacity AssessmentDiagnostic Test: Physical Fitness AssessmentOther: Quality of Life AssessmentOther: Physical Activity AssessmentOther: Cognitive Health AssessmentOther: Health Literacy Assessment

Interventions

To examine the relationship between exercise capacity and physical fitness of dyslipidemia patients and quality of life, cognitive status and health literacy.

Patient Group

* 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.

Patient Group

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.

Patient Group

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.

Patient Group

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.

Patient Group

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.

Patient Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with dyslipidemia

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DyslipidemiasMotor Activity

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 20, 2024

Study Start

August 20, 2024

Primary Completion

December 15, 2024

Study Completion

December 30, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations