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Clinical Trials in Turkey / NCT06318741
Starting soon Not applicable

Effects of Aerobic Exercise in Obese Patients with Atherosclerotic Cardiovascular Disease

NCT06318741 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-10
Last updated
2024-09-19

Condition(s) studied

ObesityCoronary Artery Disease

Investigational drug(s) / intervention(s)

aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints.Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints.

aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints.: aerobic exercise on the treadmill

Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints.: Walking at an intensity of 12-13 RPE

Study summary

Obesity is classified using body mass index (BMI) (BMI ≥25 overweight, BMI ≥30 obese, BMI ≥40 morbidly obese). Obese patients are Class 1 according to BMI; BMI:30-34.9 and Class 2; BMI: It is classified as 35-39.9. Patients with classes 1 and 2 will be included in the study. Obesity can be accompanied by comorbidities such as atherosclerotic vascular and cardiac pathologies, hyperlipidemia, hypertension, coronary artery disease, diabetes mellitus, so obesity treatment should be managed multidisciplinary. The basic approach to obesity treatment is diet, exercise, medical treatment, treatment of comorbid conditions and surgery. Aerobic exercise therapy, which is one of the conservative approaches in the treatment of obesity, also has an important place in the treatment of cardiovascular diseases associated with obesity. Atherosclerotic cardiovascular disease (AKD) is one of the most important causes of morbidity and mortality worldwide. Negative changes in functional capacity, quality of life and psychosocial situations are observed due to disorders associated with this disease. Physical activity is among the modifiable risk factors in atherosclerotic diseases. However, patients have a fear of movement related to angina-like symptoms, with the thought that the symptoms may recur during exercise. Lack of physical activity due to fear of movement leads to obesity, which in turn leads to aggravation of atherosclerosis and an increase in the incidence of cardiovascular events, which negatively affects individual and psychosocial capacity. Cardiopulmonary exercise test (CPET) is a non-invasive procedure that evaluates the individual's capacity during dynamic exercise and provides diagnostic and prognostic information. CPET is based on the investigation of the respiratory system, cardiovascular system and cellular response to exercise performed under controlled metabolic conditions. It allows holistic evaluation of the response to exercise, including not only the pulmonary and cardiovascular systems but also the musculoskeletal system. Fear of movement or kinesiophobia; It is defined as a state of fear and avoidance of activity and physical movement resulting from the feeling of sensitivity to painful injury and repeated injury.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Class 1 and class 2 obese patients with a BMI of 30 kg/m2 and above and below 40 kg/m2 2. Patients with atherosclerotic cardiovascular disease diagnosed by angiography 3. Women and men aged 18-65 4. Individuals who agree to participate in the study and have received a written voluntary consent form. Exclusion Criteria: 1. Clinical neuromuscular diseases that limit exercise, previous diagnosis of asthma, congestive heart failure, unstable angina, uncontrolled psychiatric disease or cognitive-cognitive disorders (confirmed and diagnosed in International Classification of Disease (ICD)-10 diagnosis codes 'Schizophrenia and Psychotic states (F20, F20.0, F20.1, F20.2, F20.3, F20.4, F20.5, F20.6, F20.8, F20.9, F06.2, F23.0, F23.1, F23.2, F29) , Bipolar Disorder (F31, F31.0, F31.1, F31.2, F31.3, F31.4, F31.5, F31.6, F31.7, F31.8, F31.9) and Substance Abuse (Patients with diagnosis code ' (Z86.4)') 2. Presence of uncontrolled systemic diseases * Uncontrolled hypertension, * Uncontrolled diabetes mellitus, * Chronic liver failure * Chronic renal failure and dialysis patients * Chronic obstructive pulmonary disease and asthma 3. Malignancy 4. Infection 5. High fever 6. Acute inflammatory rheumatic diseases 7. Acute peripheral vascular diseases 8. Smoking before exercise test 9. Alcohol consumption before exercise test 10. Use of medications known to affect physical performance, heart rate or metabolism (including Beta blockers) 11. Patients without cooperation and compliance 12. Patients who did not agree to participate in the study 13. Patients who have been included in the cardiopulmonary rehabilitation (CPR) program in the last year 14. With acute coronary syndrome 15. Troponin positive 16. Unstable angina pectoris 17. Basic contraindications of exercise test: * High risk unstable angina * Acute Cardiac Diseases (Acute MI, Acute endocarditis, myocarditis or pericarditis, Acute pulmonary embolism, etc.) * Uncontrolled arrhythmias that can disrupt the hemodynamic response * Symptomatic severe aortic stenosis * Decompensated heart failure * Non-cardiac pathologies that will affect exercise performance and be aggravated by exercise (e.g. infection, renal failure, thyrotoxicosis).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital Kayseri Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06318741 on ClinicalTrials.gov ↗ ← All trials in Turkey