Effects of Aerobic Exercise in Obese Patients with Atherosclerotic Cardiovascular Disease

NCT06318741 | Not Yet Recruiting

• 1 other identifier: KayseriCHkinezyofobi
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Coronary Artery Disease

Outcome Measures

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.

  week 0, 8th week, 20th week

Secondary Outcomes (7)

• Cardiopulmonary exercise test

  week 0, 8th week, 20th week

• 6 Minutes Walking Test

  week 0, 8th week, 20th week

• Body anthropometric measurements

  week 0, 8th week, 20th week

• Hospital anxiety and depression scale

  week 0, 8th week, 20th week

• international physical activity score

  week 0, 8th week, 20th week

Study Arms (2)

hospital exercise group

ACTIVE COMPARATOR

According to the Cardiopulmonary exercise test (KPET) test in Group 1 (medium intensity continuous exercise group), 50 minutes (5 minutes warm-up, 40 minutes exercise, 5 minutes exercise, 5 minutes warm-up, 40 minutes exercise, 5 minutes) for 8 weeks, 3 days a week, at an exercise intensity of 50-60% of the VO2 max level recorded individually in the patients. Aerobic exercise therapy will be organized to be applied on a treadmill (in the form of a minute cool-down).

Other: 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.

home exercise group

PLACEBO COMPARATOR

For the home exercise group, walking for 50 minutes, 3 days a week, with an intensity of 12-13 Rate of perceived exertion (RPE) according to the Modified Borg scale will be recommended for 8 weeks.

Other: 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.

Interventions

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

aerobic exercise on the treadmill

hospital exercise group

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

Walking at an intensity of 12-13 RPE

home exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Chronic liver failure
• Chronic renal failure and dialysis patients
• Chronic obstructive pulmonary disease and asthma
• Malignancy
• Infection
• High fever
• Acute inflammatory rheumatic diseases
• Acute peripheral vascular diseases
• Smoking before exercise test
• Alcohol consumption before exercise test
• Use of medications known to affect physical performance, heart rate or metabolism (including Beta blockers)

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

Related Publications (17)

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MeSH Terms

Conditions

Obesity; Coronary Artery Disease

Interventions

Posture

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fatma Gül Ülkü Demir, MD

  Kayseri City Hospital

  STUDY DIRECTOR

• Selim Oğuz, MD

  Health Sciences University, Kayseri Medical Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Havva Talay Çalış, Prof

CONTACT

03523157700; htalaycalis@yahoo.com

Selim Oğuz, MD

CONTACT

05062227012; mdselimoguz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)