Clinical trial NCT06318741: Effects of Aerobic Exercise in Obese Patients with Atherosclerotic Cardiovascular Disease
Official title: Effects of Aerobic Exercise on Kinesiophobia, Functional Capacity and Quality of Life in Obese Patients with Atherosclerotic Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Coronary Artery Disease
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Obesity, defined by the World Health Organization (WHO) as "abnormal or excessive fat accumulation in the body that negatively affects health", has become an important public health problem that affects the quality of life at individual and social levels. Obesity is defined by using body mass index (BMI) (BMI ≥ 25 patients are classified as overweight, BMI ≥30 as obese, BMI ≥40 as morbidly obese. Obese patients are classified according to BMI as Class 1, BMI: 30-34.9 and Class 2, BMI: 35-39.9. Class 1 and 2 patients were included in the study. Patients will be included. Obesity can be accompanied by comorbidities such as atherosclerotic vascular and cardiac pathologies, hyperlipidemia, hypertension, coronary artery disease, diabetes mellitus and chronic musculoskeletal disorders such as osteoarthritis, low back pain and fibromyalgia. Therefore, obesity treatment should be managed multidisciplinary. The basic approach in 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. Anthropometry is the investigation of measurements of the human body in terms of bone dimensions, muscle and fat tissue. Anthropometric measurements are measurements that reveal the composition and body size / structure of the human body. Anthropometric measurements gain importance when evaluating the nutritional status of people because they show body fat storage and protein storage. Evaluation of growth and body composition, that is, body fat and lean body tissue, can be determined by anthropometric measurements. Anthropometric measurements help analyze the relationship between obesity and diseases. Anthropometric measurements are important for evaluating the nutritional status of a population or individual. 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. Kinesiophobia is assessed with the Tampa Kinesiophobia Scale. This scale, consisting of 17 items, evaluates how afraid patients are of moving their bodies. A high score indicates a high level of fear of movement, while a low score indicates a negligible level of fear of movement. Each item is scored on a 4-point Likert Scale; 1-4. The answers and their numerical values are as follows: 1; Strongly disagree, 2; disagree, 3; agree and 4; I totally agree. The scores of items 4, 8, 12 and 16 should be reversed when calculating the total score. The total score obtained by adding different items may vary between 17 and 68. Previous studies have shown that this scale is generally applied to patients with low back pain, knee osteoarthritis, lymphedema and osteoporosis. In the literature, there are limited age group and uncontrolled studies in patients with cardiovascular disease. However, to the best of this knowledge, this study will be one of the limited number of blind, prospective, randomized controlled studies in the literature that evaluate fear of movement in obese patients with atherosclerotic cardiovascular disease who receive aerobic exercise therapy. The aim of this study is to investigate the effects of an aerobic exercise program on anthropometric measurements, kinesiophobia, psychosocial status, physical activity level and quality of life in obese individuals with atherosclerotic cardiovascular disease. This hypothesis in this study is that an aerobic exercise program will cause significant changes in anthropometric measures, kinesiophobia and quality of life in obese patients with atherosclerotic heart disease. In this study, it is expected that a regular, supervised aerobic exercise program will create a more effective response in terms of physical, psychosocial and patient compliance in the individual compared to a home exercise program in obese individuals who often have a sedentary lifestyle, and therefore will provide a change in anthropometric measurements. Patients who are admitted to Kayseri City Hospital Physical Medicine and Rehabilitation Clinic Cardiopulmonary Rehabilitation Unit, between the ages of 18-65, with a BMI of 30-40, with class 1 and 2 obese atherosclerotic cardiovascular pathology, and with American Heart Association stage B and New York Heart Association class 1 will be included in this study. Patients participating in the study will be randomized into 2 groups: moderate-intensity continuous exercise group (Group 1) and home exercise group (Group 2). The change in the average Tampa Scale Kinesiophobia (TSK) score of each group over time will be evaluated within the 0th, 8th and 20th weeks. Additionally, the change in the average TSK scores between the two groups over time (0th, 8th and 20th weeks) will be compared. In this hypothesis; A decrease in TSK score is expected over time with the exercise program. The minimum sample size required to find a significant difference between both groups was determined by Jiménez et al. It was calculated in the G\*Power 3.1.9.4 program, using the study as a reference. According to these criteria; While the power of the test (1-β) is 0.80, the amount of type-1 error (α) is 0.05, and the alternative hypothesis (H1) is one-sided, the minimum sample size required to find a significant difference between the groups is a total of 28 patients, 14 patients in each group. calculated as a patient. The dropout rate was estimated to be 10%. Therefore, a total of 32 patients will be included in the study, 16 patients in both groups.

Eligibility criteria: 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 outcomes:
measure: Tampa Kinesiophobia Scale
timeFrame: week 0, 8th week, 20th week
Secondary outcomes:
measure: Cardiopulmonary exercise test
timeFrame: week 0, 8th week, 20th week
measure: 6 Minutes Walking Test
timeFrame: week 0, 8th week, 20th week
measure: Body anthropometric measurements
timeFrame: week 0, 8th week, 20th week
measure: Hospital anxiety and depression scale
timeFrame: week 0, 8th week, 20th week
measure: international physical activity score
timeFrame: week 0, 8th week, 20th week
measure: MacNew Heart Disease Health-Related Quality of Life Survey
timeFrame: week 0, 8th week, 20th week
measure: Numerical Rating Scale
timeFrame: week 0, 8th week, 20th week
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
Study officials:
affiliation: Kayseri City Hospital
name: Fatma Gül Ülkü Demir, MD
role: STUDY_DIRECTOR
affiliation: Health Sciences University, Kayseri Medical Faculty
name: Selim Oğuz, MD
role: PRINCIPAL_INVESTIGATOR
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