NCT06008912

Brief Summary

Dyslipidemia is expressed as the serum concentration of lipid molecules with different structures outside the normal level. Deviation of serum lipid level from normal is accepted as the primary or most important factor in various cardiac and metabolic diseases, especially atherosclerosis. Dyslipidemia-related cardiovascular structure change is accepted as an important public health problem worldwide, and it is stated that the combined use of medical treatment, changes in diet and physical activity/structured exercise programs in the treatment of dyslipidemia is important in the success of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

Study Start

First participant enrolled

May 14, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

August 8, 2023

Last Update Submit

December 30, 2024

Conditions

Keywords

DyslipidemiaCalisthenic ExerciseExercise Capacity

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Cardiopulmonary exercise capacity will assess as primary outcome measure, via cardiopulmonary exercise test (CPET).

    Second Day

Secondary Outcomes (9)

  • Blood Lipids Concentration Assessment

    First Day

  • Apolipoprotein A1 Concentration Assessment

    First Day

  • Blood Sugar Concentration Assessment

    First Day

  • C-reactive Protein Concentration Assessment

    First Day

  • Sit-to-Stand Test

    First Day

  • +4 more secondary outcomes

Other Outcomes (1)

  • Quality of Life Assessment

    Second Day

Study Arms (3)

Calisthenic + Aerobic Exercise Group

EXPERIMENTAL

Patients will take aerobic exercise training in 3 days per week, and 7 days per week calisthenic exercises for upper extremity, lower extremity and trunk, for 8 weeks.

Other: Calisthenic ExercisesOther: Aerobic Exercises

Aerobic Exercise Group

ACTIVE COMPARATOR

Patients will take aerobic exercise training in 3 days per week, for 8 weeks.

Other: Aerobic Exercises

Control Group

NO INTERVENTION

Patients will take physical activity recommendations, and just screening after 8 weeks.

Interventions

Exercises for upper extremity, lower extremity and trunk which applying just patient's own body weight via using body mechanics. There is no need for any tools for exercises.

Calisthenic + Aerobic Exercise Group

Exercises which loading cardiovascular, respiratory and muscular system at the same time. Treadmill training will apply in the study.

Aerobic Exercise GroupCalisthenic + Aerobic Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Screening by the internal medicine clinic with the diagnosis of dyslipidemia
  • Being between 18 to 65 years old
  • Volunteering to participate in the research

You may not qualify if:

  • Having any cardiac disease
  • Having a co-existing psychiatric illness (like schizophrenia, bipolar disorder, etc.)
  • Being infected with COVID-19 in the last 3 months
  • Having any neurological problems that may affect cooperation
  • Having pulmonary or orthopedic problem that may affect functional capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (16)

  • GBD 2015 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1659-1724. doi: 10.1016/S0140-6736(16)31679-8.

    PMID: 27733284BACKGROUND
  • Rivas-Gomez B, Almeda-Valdes P, Tussie-Luna MT, Aguilar-Salinas CA. DYSLIPIDEMIA IN MEXICO, A CALL FOR ACTION. Rev Invest Clin. 2018;70(5):211-216. doi: 10.24875/RIC.18002573.

    PMID: 30307444BACKGROUND
  • Pan L, Yang Z, Wu Y, Yin RX, Liao Y, Wang J, Gao B, Zhang L; China National Survey of Chronic Kidney Disease Working Group. The prevalence, awareness, treatment and control of dyslipidemia among adults in China. Atherosclerosis. 2016 May;248:2-9. doi: 10.1016/j.atherosclerosis.2016.02.006. Epub 2016 Feb 27.

    PMID: 26978581BACKGROUND
  • Zhang M, Deng Q, Wang L, Huang Z, Zhou M, Li Y, Zhao Z, Zhang Y, Wang L. Prevalence of dyslipidemia and achievement of low-density lipoprotein cholesterol targets in Chinese adults: A nationally representative survey of 163,641 adults. Int J Cardiol. 2018 Jun 1;260:196-203. doi: 10.1016/j.ijcard.2017.12.069.

    PMID: 29622441BACKGROUND
  • Yang F, Ma Q, Ma B, Jing W, Liu J, Guo M, Li J, Wang Z, Liu M. Dyslipidemia prevalence and trends among adult mental disorder inpatients in Beijing, 2005-2018: A longitudinal observational study. Asian J Psychiatr. 2021 Mar;57:102583. doi: 10.1016/j.ajp.2021.102583. Epub 2021 Feb 5.

    PMID: 33581368BACKGROUND
  • GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.

    PMID: 33069326BACKGROUND
  • Tietge UJ. Hyperlipidemia and cardiovascular disease: inflammation, dyslipidemia, and atherosclerosis. Curr Opin Lipidol. 2014 Feb;25(1):94-5. doi: 10.1097/MOL.0000000000000051. No abstract available.

    PMID: 24398450BACKGROUND
  • Villarreal-Molina MT, Aguilar-Salinas CA, Rodriguez-Cruz M, Riano D, Villalobos-Comparan M, Coral-Vazquez R, Menjivar M, Yescas-Gomez P, Konigsoerg-Fainstein M, Romero-Hidalgo S, Tusie-Luna MT, Canizales-Quinteros S; Metabolic Study Group. The ATP-binding cassette transporter A1 R230C variant affects HDL cholesterol levels and BMI in the Mexican population: association with obesity and obesity-related comorbidities. Diabetes. 2007 Jul;56(7):1881-7. doi: 10.2337/db06-0905. Epub 2007 Feb 7.

    PMID: 17287470BACKGROUND
  • Villarreal-Molina MT, Flores-Dorantes MT, Arellano-Campos O, Villalobos-Comparan M, Rodriguez-Cruz M, Miliar-Garcia A, Huertas-Vazquez A, Menjivar M, Romero-Hidalgo S, Wacher NH, Tusie-Luna MT, Cruz M, Aguilar-Salinas CA, Canizales-Quinteros S; Metabolic Study Group. Association of the ATP-binding cassette transporter A1 R230C variant with early-onset type 2 diabetes in a Mexican population. Diabetes. 2008 Feb;57(2):509-13. doi: 10.2337/db07-0484. Epub 2007 Nov 14.

    PMID: 18003760BACKGROUND
  • De Sousa SM Dr, Norman RJ Prof. Metabolic syndrome, diet and exercise. Best Pract Res Clin Obstet Gynaecol. 2016 Nov;37:140-151. doi: 10.1016/j.bpobgyn.2016.01.006. Epub 2016 Feb 10.

    PMID: 26972165BACKGROUND
  • Wang Y, Xu D. Effects of aerobic exercise on lipids and lipoproteins. Lipids Health Dis. 2017 Jul 5;16(1):132. doi: 10.1186/s12944-017-0515-5.

    PMID: 28679436BACKGROUND
  • Miles L. Physical activity and health. Nutr Bull [Internet]. 2007 Dec;32(4):314-63. Available from: http://doi.wiley.com/10.1111/j.1467-3010.2007.00668.x

    BACKGROUND
  • Strunk RC, Mrazek DA, Fukuhara JT, Masterson J, Ludwick SK, LaBrecque JF. Cardiovascular fitness in children with asthma correlates with psychologic functioning of the child. Pediatrics. 1989 Sep;84(3):460-4.

    PMID: 2771549BACKGROUND
  • Carson KV, Chandratilleke MG, Picot J, Brinn MP, Esterman AJ, Smith BJ. Physical training for asthma. Cochrane Database Syst Rev. 2013 Sep 30;2013(9):CD001116. doi: 10.1002/14651858.CD001116.pub4.

    PMID: 24085631BACKGROUND
  • Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. Int J Behav Nutr Phys Act. 2013 Aug 15;10:98. doi: 10.1186/1479-5868-10-98.

    PMID: 23945179BACKGROUND
  • Ozdemir F, Saglam M, Aksel Uylar AA, Uyaroglu OA, Basaran NC, Tanriover MD, Yagli NV. Could calisthenic exercises improve maximal exercise capacity, peripheral muscle strength and quality of life in dyslipidemia? PLoS One. 2025 Jun 17;20(6):e0326026. doi: 10.1371/journal.pone.0326026. eCollection 2025.

MeSH Terms

Conditions

Dyslipidemias

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Patients and his/her caregivers will allocate in study via computer based randomisation, and will not know about his/her and also other participants group in study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental model of study consist from three arm. * First Arm: Patients will take aerobic exercise training in 3 days per week, and 7 days per week calisthenic exercises for upper extremity, lower extremity and trunk, for 8 weeks. * Second Arm: Patients will take aerobic exercise training in 3 days per week, for 8 weeks. * Third Arm: Patients will take physical activity recommendations, and just screening after 8 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 24, 2023

Study Start

May 14, 2023

Primary Completion

July 31, 2024

Study Completion

December 1, 2024

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations