Effects of Aerobic Exercise in Obese Patients with Atherosclerotic Cardiovascular Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKayseri City Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Class 1 and class 2 obese patients with a BMI of 30 kg/m2 and above and below 40 kg/m2

Patients with atherosclerotic cardiovascular disease diagnosed by angiography

Women and men aged 18-65

Individuals who agree to participate in the study and have received a written voluntary consent form.

Disqualifiers

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)')

Presence of uncontrolled systemic diseases

Uncontrolled hypertension,

Uncontrolled diabetes mellitus,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

    Other intervention

    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.

    Other intervention

    Walking at an intensity of 12-13 RPE

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: hospital exercise groupActive comparator 1 intervention
Group B: home exercise groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tampa Kinesiophobia Scale

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. 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.

Time frame
week 0, 8th week, 20th week

Secondary outcomes

1

Cardiopulmonary exercise test

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.

Time frame
week 0, 8th week, 20th week
2

6 Minutes Walking Test

It is a frequently used test in cardiopulmonary rehabilitation to monitor exercise capacity and treatment effectiveness. The patient should rest by sitting in a chair for 15 minutes before the test and wear appropriate shoes and comfortable clothing. Calculate the distance walked by the patient at their own walking pace in 6 minutes, preferably in a 30-meter long corridor.

Time frame
week 0, 8th week, 20th week
3

Body anthropometric measurements

Waist circumference, hip circumference, waist/hip ratio, waist/height ratio.

Time frame
week 0, 8th week, 20th week
4

Hospital anxiety and depression scale

The Hospital Anxiety and Depression (HADS) Scale was prepared to screen for anxiety and depression in people with physical illnesses.

Time frame
week 0, 8th week, 20th week

Other outcomes

Sponsors and contacts

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