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Completed

NCT Number: NCT06008912

Effect of Calisthenic Exercise Training Combined With Aerobic Exercise 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.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Calisthenic Exercises

Other

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 exercises

Other

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

Primary outcomes

  1. Exercise Capacity

    Time frame: Second Day

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

Secondary outcomes

  1. Blood Lipids Concentration Assessment

    Time frame: First Day

    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.

  2. Apolipoprotein A1 Concentration Assessment

    Time frame: First Day

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

  3. Blood Sugar Concentration Assessment

    Time frame: First Day

    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.

  4. C-reactive Protein Concentration Assessment

    Time frame: First Day

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

  5. Sit-to-Stand Test

    Time frame: First Day

    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)

  6. Timed Up-and-Go Test

    Time frame: First Day

    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).

  7. Peripheral Muscle Strength Assessment

    Time frame: First Day

    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.

  8. Hand-Grip Strength Assessment

    Time frame: First Day

    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.

  9. Flexibility Assessment

    Time frame: First Day

    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.

Other outcomes

  1. Quality of Life Assessment

    Time frame: Second Day

    Quality of life will assess via Short Form-36 Quality of Life Questionnaire. The questionnaire consist from 36 questions and total score ranges between 0 to 100 point. Higher scores shows better quality of life.

Sponsors and collaborators

Lead sponsor

Çankırı Karatekin University

Other

Collaborators

  • Hacettepe University

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 24, 2023
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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