Effects of Aerobic Exercise in Obese Patients With Atherosclerotic Cardiovascular Disease

March 13, 2024 updated by: Havva Talay Çalış, Kayseri City Hospital

Effects of Aerobic Exercise on Kinesiophobia, Functional Capacity and Quality of Life in Obese Patients With Atherosclerotic Cardiovascular Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Kayseri, Turkey, 38080
        • Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hospital exercise group
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.
aerobic exercise on the treadmill
Placebo Comparator: home exercise group
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.
Walking at an intensity of 12-13 RPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tampa Kinesiophobia Scale
Time Frame: week 0, 8th week, 20th week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary exercise test
Time Frame: week 0, 8th week, 20th week
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.
week 0, 8th week, 20th week
6 Minutes Walking Test
Time Frame: week 0, 8th week, 20th week
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.
week 0, 8th week, 20th week
Body anthropometric measurements
Time Frame: week 0, 8th week, 20th week
Waist circumference, hip circumference, waist/hip ratio, waist/height ratio.
week 0, 8th week, 20th week
Hospital anxiety and depression scale
Time Frame: week 0, 8th week, 20th week
The Hospital Anxiety and Depression (HADS) Scale was prepared to screen for anxiety and depression in people with physical illnesses.
week 0, 8th week, 20th week
international physical activity score
Time Frame: week 0, 8th week, 20th week
It is a survey consisting of 7 questions that patients will answer and provides information about the time spent in sitting, walking, moderate and vigorous activities. The total score is obtained by calculating the time (minutes) and weekly frequencies (days) spent in these activities.
week 0, 8th week, 20th week
MacNew Heart Disease Health-Related Quality of Life Survey
Time Frame: week 0, 8th week, 20th week
It is designed to assess the patient's feelings about how ischemic heart disease affects daily functioning and includes 27 items, a global HRQoL score and physical limitation, emotional, and social function subscales, along with a summary of available international results.
week 0, 8th week, 20th week
Numerical Rating Scale
Time Frame: week 0, 8th week, 20th week
It is used as a measure of pain intensity in adults. 0;no pain, 10; It is the strongest pain felt
week 0, 8th week, 20th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri City Hospital

Investigators

  • Study Director: Fatma Gül Ülkü Demir, MD, Kayseri City Hospital
  • Principal Investigator: Selim Oğuz, MD, Health Sciences University, Kayseri Medical Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KayseriCHkinezyofobi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe