search
Back to results

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

Primary Purpose

Dyslipidemias

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Calisthenic Exercises
Aerobic Exercises
Sponsored by
Çankırı Karatekin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Dyslipidemia, Calisthenic Exercise, Exercise Capacity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Calisthenic + Aerobic Exercise Group

Aerobic Exercise Group

Control Group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Apolipoprotein A1 Concentration Assessment
Concentration of Apolipoprotein A1 will assess in blood (in g/dL units of measure) after 12 hours fasting.
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.
C-reactive Protein Concentration Assessment
Concentration of C-reactive protein (in mg/dL units of measure) will assess in blood after 12 hours fasting.
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)
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).
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.
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.
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.

Full Information

First Posted
August 8, 2023
Last Updated
August 23, 2023
Sponsor
Çankırı Karatekin University
Collaborators
Hacettepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT06008912
Brief Title
Effect of Calisthenic Exercise Training Combined With Aerobic Exercise in Patients With Dyslipidemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 14, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Çankırı Karatekin University
Collaborators
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
Dyslipidemia, Calisthenic Exercise, Exercise Capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calisthenic + Aerobic Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic Exercise Group
Arm Type
Active Comparator
Arm Description
Patients will take aerobic exercise training in 3 days per week, for 8 weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients will take physical activity recommendations, and just screening after 8 weeks.
Intervention Type
Other
Intervention Name(s)
Calisthenic Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercises
Intervention Description
Exercises which loading cardiovascular, respiratory and muscular system at the same time. Treadmill training will apply in the study.
Primary Outcome Measure Information:
Title
Exercise Capacity
Description
Cardiopulmonary exercise capacity will assess as primary outcome measure, via cardiopulmonary exercise test (CPET).
Time Frame
Second Day
Secondary Outcome Measure Information:
Title
Blood Lipids Concentration Assessment
Description
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.
Time Frame
First Day
Title
Apolipoprotein A1 Concentration Assessment
Description
Concentration of Apolipoprotein A1 will assess in blood (in g/dL units of measure) after 12 hours fasting.
Time Frame
First Day
Title
Blood Sugar Concentration Assessment
Description
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.
Time Frame
First Day
Title
C-reactive Protein Concentration Assessment
Description
Concentration of C-reactive protein (in mg/dL units of measure) will assess in blood after 12 hours fasting.
Time Frame
First Day
Title
Sit-to-Stand Test
Description
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)
Time Frame
First Day
Title
Timed Up-and-Go Test
Description
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).
Time Frame
First Day
Title
Peripheral Muscle Strength Assessment
Description
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.
Time Frame
First Day
Title
Hand-Grip Strength Assessment
Description
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.
Time Frame
First Day
Title
Flexibility Assessment
Description
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.
Time Frame
First Day
Other Pre-specified Outcome Measures:
Title
Quality of Life Assessment
Description
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.
Time Frame
Second Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naciye Vardar-Yağlı, Prof. Dr.
Phone
+90-546-237-1990
Email
naciyevardar@yahoo.com
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27733284
Citation
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. Erratum In: Lancet. 2017 Jan 7;389(10064):e1.
Results Reference
background
PubMed Identifier
30307444
Citation
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.
Results Reference
background
PubMed Identifier
26978581
Citation
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.
Results Reference
background
PubMed Identifier
29622441
Citation
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. Erratum In: Int J Cardiol. 2018 May 12;:
Results Reference
background
PubMed Identifier
33581368
Citation
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.
Results Reference
background
PubMed Identifier
33069326
Citation
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. Erratum In: Lancet. 2020 Nov 14;396(10262):1562.
Results Reference
background
PubMed Identifier
24398450
Citation
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.
Results Reference
background
PubMed Identifier
17287470
Citation
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.
Results Reference
background
PubMed Identifier
18003760
Citation
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.
Results Reference
background
PubMed Identifier
26972165
Citation
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.
Results Reference
background
PubMed Identifier
28679436
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
2771549
Citation
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.
Results Reference
background
PubMed Identifier
24085631
Citation
Carson KV, Chandratilleke MG, Picot J, Brinn MP, Esterman AJ, Smith BJ. Physical training for asthma. Cochrane Database Syst Rev. 2013 Sep 30;(9):CD001116. doi: 10.1002/14651858.CD001116.pub4.
Results Reference
background
PubMed Identifier
23945179
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs