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DyslipidemiasNCT06008912

Effect of Calisthenic Exercise Training Combined With Aerobic Exercise in Patients With Dyslipidemia

A study testing Calisthenic Exercises and Aerobic Exercises in people with Dyslipidemias, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Dyslipidemias
What is being tested?
Calisthenic Exercises and Aerobic Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 May 2023to 1 Dec 2024
Phase
Interventional
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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect of Calisthenic Exercise Training Combined With Aerobic Exercise on Exercise Tolerance, Physical Fitness and Plasma Lipid Profile in Patients With Dyslipidemia

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.

Read the detailed description

Lipid profile disorders (especially high total blood cholesterol level) are a major problem worldwide, and accepted as a important public health problem. It has been reported that approximately one out of every three people worldwide has been exposed to dyslipidemia risk factors. Prevalence studies showed that lipid profile disorders vary between 6.9% and 43.6% worldwide. Today, ischemic heart and central nervous system diseases are the most important causes of mortality and morbidity in adult population, globally. Especially, it is accepted that lipid profile disorders are the leading risk factors causing ischemic heart diseases.

Prevalence varies according to regions, lifestyle habits and individual factors, because of lipid profile disorders are caused by many different genetic and environmental factors. Apart from individual factors, there are other factors that lipid weight in diet, nutrient deficiencies which balancing lipid metabolism, physical activity level and inactivity, other comorbid diseases, and medical treatments change lipid metabolism in individuals and lead to deterioration in lipid profile. Especially lifestyle habits affect lipid metabolism most easily and they are the most easily modifiable factors.

It is recommended to apply a multi-dimensional approach when treating lipid profile disorders. It is recommended that, to include diet counseling and exercise therapy in these approaches. Exercise therapy is especially recognized as an important treatment option for the control and treatment of obesity, hypertension, hyperglycemia and metabolic syndrome symptoms that may accompany dyslipidemia.

It has been reported that aerobic exercise programs increase patients' quality of life and functionality which applied to dyslipidemia patients, but there is lack of information available in literature about the effects of calisthenic exercises in patients with dyslipidemia.

Conditions
Dyslipidemias
Being tested
Calisthenic Exercises, Aerobic Exercises
Keywords
Dyslipidemia, Calisthenic Exercise, Exercise Capacity
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calisthenic ExercisesOther

    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.

  • Aerobic ExercisesOther

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

Study groups in NCT06008912
Study groupRoleWhat they receive
Calisthenic + Aerobic Exercise GroupExperimentalPatients 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.
Receives: Other: Calisthenic Exercises; Other: Aerobic Exercises
Aerobic Exercise GroupActive comparatorPatients will take aerobic exercise training in 3 days per week, for 8 weeks.
Receives: Other: Aerobic Exercises
Control GroupNo interventionPatients will take physical activity recommendations, and just screening after 8 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise Capacity

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

    Measured: Second Day

Secondary outcomes (9)
  1. Blood Lipids Concentration Assessment

    Concentration of LDL-C, HDL-C, Total cholesterol (TC) and Triglyceride (TG) will assess in blood (in mg/dL units of measure) after 12 hours fasting.

    Measured: First Day

  2. Apolipoprotein A1 Concentration Assessment

    Concentration of Apolipoprotein A1 will assess in blood (in g/dL units of measure) after 12 hours fasting.

    Measured: First Day

  3. Blood Sugar Concentration Assessment

    Concentration of fasting blood sugar (in mmol/L units of measure) and rate of HbA1c (in % units of measure) will assess in blood after 12 hours fasting.

    Measured: First Day

  4. C-reactive Protein Concentration Assessment

    Concentration of C-reactive protein (in mg/dL units of measure) will assess in blood after 12 hours fasting.

    Measured: First Day

  5. Sit-to-Stand Test

    A one-minute sit-to-stand test will be applied to the patients. One standing position followed by sitting will count as one cycle. Patients' total cycles within 60 seconds will be counted as test score (in cycle/minute units of measure)

    Measured: First Day

  6. Timed Up-and-Go Test

    Timed up-and-go test will be applied to the patients. Patients will be asked to get up from the chair, walk the 3-meter distance, return and sit back in the chair, as quickly as possible. The total time that patients complete the test and sit on the chair again will be recorded as the test score (in second/lap units of measure).

    Measured: First Day

  7. Peripheral Muscle Strength Assessment

    The muscle strength of the shoulder abductor and knee extensor muscles on the dominant and non-dominant sides of the patients will be evaluated with a portable dynamometer. During the evaluations, the patients will be asked to try to resist the force to be applied in the opposite direction of the relevant muscle's function with isometric muscle contraction. The force released during the test will be measured and the highest score (in newton [N] units of measure) will be recorded for each muscle within 3 tests.

    Measured: First Day

  8. Hand-Grip Strength Assessment

    The hand grip strength of the patients will be measured with a portable hand dynamometer. The patients will be asked to grasp the dynamometer with their fingers on the dominant and non-dominant side and squeeze it most strongly. The highest score (in kilogram force [KgF] units of measure) of 3 measurements on both sides will be recorded.

    Measured: First Day

  9. Flexibility Assessment

    Flexibility of patients will be evaluated with sit-and-reach test. Patients will be asked to stretch their hands on a bench with a measuring ruler while in a long sitting position with the ankle angled at 90 degrees and the knee fully extended. How many centimeters ahead or behind the toes of the patient's fingertips will be measured.

    Measured: First Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start14 May 2023
  3. Primary completion31 Jul 2024
  4. Study completion1 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008912
Sponsor's protocol ID
KA-22027
Status last verified
Dec 2024
First submitted
8 Aug 2023
Last updated
31 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27733284
  • 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.

    PubMed 30307444
  • 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.

    PubMed 26978581
  • 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.

    PubMed 29622441
  • 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.

    PubMed 33581368
  • 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.

    PubMed 33069326
  • 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.

    PubMed 24398450
  • 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.

    PubMed 17287470
  • 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.

    PubMed 18003760
  • 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.

    PubMed 26972165
  • 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.

    PubMed 28679436
  • 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

  • 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.

    PubMed 2771549
  • 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.

    PubMed 24085631
  • 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.

    PubMed 23945179

Questions about this trial

What is this clinical trial studying?

A study testing Calisthenic Exercises and Aerobic Exercises in people with 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 5 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 31 Dec 2024. 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: Second Day). 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 NCT06008912, which also lists 16 linked publications.

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 31 Dec 2024.

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