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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dyslipidemias

Intervention / Treatment
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* Other: Calisthenic Exercises
* Other: Aerobic Exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calisthenic + Aerobic Exercise Group<br>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 Exercises<br>* 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.<br>Other: Aerobic Exercises<br>* Exercises which loading cardiovascular, respiratory and muscular system at the same time. Treadmill training will apply in the study.<br>|
| Active Comparator: Aerobic Exercise Group<br>Patients will take aerobic exercise training in 3 days per week, for 8 weeks. | Other: Aerobic Exercises<br>* Exercises which loading cardiovascular, respiratory and muscular system at the same time. Treadmill training will apply in the study.<br>|
| No Intervention: Control Group<br>Patients will take physical activity recommendations, and just screening after 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity | Cardiopulmonary exercise capacity will assess as primary outcome measure, via cardiopulmonary exercise test (CPET). | Second Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | First Day | 
| Apolipoprotein A1 Concentration Assessment | Concentration of Apolipoprotein A1 will assess in blood (in g/dL units of measure) after 12 hours fasting. | First Day | 
| 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. | First Day | 
| C-reactive Protein Concentration Assessment | Concentration of C-reactive protein (in mg/dL units of measure) will assess in blood after 12 hours fasting. | First Day | 
| 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) | First Day | 
| 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). | First Day | 
| 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. | First Day | 
| 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. | First Day | 
| 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. | First Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Calisthenic Exercise, Exercise Capacity