Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318741
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-13
Brief Title:
Effects of Aerobic Exercise in Obese Patients with Atherosclerotic Cardiovascular Disease
Sponsor:
Kayseri City Hospital
Organization:
Kayseri City Hospital
Study Overview
Official Title:
Effects of Aerobic Exercise on Kinesiophobia Functional Capacity and Quality of Life in Obese Patients with Atherosclerotic Cardiovascular Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BMI30-349 and Class 2 BMI It is classified as 35-399 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 individuals 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 30-349 and Class 2 BMI 35-399 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 surgeryAerobic 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 individuals 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 GPower 3194 program using the study as a reference According to these criteria While the power of the test 1-β is 080 the amount of type-1 error α is 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None