The Influence of Cardiac Rehabilitation on the Health State After ACS
Ключови думи
Резюме
Описание
Coronary heart disease, including acute coronary syndromes (ACS), is the leading cause of death in European countries, including Poland. In addition, it is one of the main causes of disability and the number of lost years of life and the number of years of life lost in good health. The costs of its treatment include not only the primary prophylaxis of cardiovascular events, the treatment of cardiovascular events, the treatment of chronic conditions and complications such as chronic heart failure or arrhythmia, but also the secondary and tertiary prophylaxis of acute coronary syndromes.
One of the basic elements of secondary and tertiary prevention of ACS is cardiac rehabilitation. It should be implemented as soon as possible after the ACS and be part of a comprehensive, planned and systematic care of the patient after ACS. The beneficial effect of cardiac rehabilitation on the cardiovascular system, lipid and carbohydrate metabolism and physical performance has been demonstrated in a way that does not raise any doubts. However, in the light of the growing epidemic of civilization diseases such as excessive body mass, diabetes, dyslipidemia, hypertension and other cardiometabolic disorders, it is necessary to conduct high-quality research on the development of the most effective cardiac rehabilitation programs, so as to maximize their beneficial effect on patients' health.
The aims of the study are:
1. Evaluation of the impact of cardiac rehabilitation on selected anthropometric, biochemical, mineral parameters, body composition parameters, physical fitness parameters and cardiovascular function parameters in patients after acute coronary syndrome.
2. Assessment of lifestyle, acceptance of disease, quality of life, diet and psychological profile and the influence of these factors on the course of cardiac rehabilitation in patients after acute coronary syndrome.
3. Evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease and predisposing conditions (including excessive body weight, hypertension, lipid and carbohydrate disorders, impaired vascular endothelial function) on the course of cardiac rehabilitation in patients after acute coronary syndrome and searching for new genes that may affect the course of cardiac rehabilitation in this group of patients.
Research hypotheses:
1. Cardiac rehabilitation has a positive effect on selected anthropometric, biochemical, mineral parameters, body composition parameters, physical fitness parameters and cardiovascular function parameters in patients after acute coronary syndrome.
2. Lifestyle, acceptance of disease, quality of life, diet and psychological profile have a significant impact on the course of cardiac rehabilitation in patients after acute coronary syndrome.
3. The level of expression and gene polymorphism of genes associated with ischemic heart disease and predisposing conditions (including excessive body weight, hypertension, lipid and carbohydrate disorders, impaired vascular endothelial function) have a significant impact on the course of cardiac rehabilitation in patients after acute coronary syndrome.
The study will consist of a retrospective and prospective part. The retrospective part will include patients who have had acute coronary syndrome in the past and then - before being included in the study - have undergone cardiac rehabilitation. In the retrospective part, patients enrolled in the study will not undergo cardiac rehabilitation as a part of the study intervention. In contrast, the prospective part will include patients who have had an acute coronary syndrome in the past and will undergo cardiac rehabilitation as the study intervention.
About 200 women and men aged 18 to 99 are planned to be included in the study.
After being included in the study, patients will undergo medical examination and their medical documentation will be collected, analyzed, copied and archived. Then subsequent procedures will be performed:
- anthropometric measurements (body weight, height, hip, waist, neck circumference measurement)
- ECG - electrocardiography
- non-invasive analysis of the body composition by bioimpedance
- non-invasive measurement of resting blood pressure, resting heart rate and oxygen saturation of hemoglobin
- non-invasive pulse wave analysis
- non-invasive transthoracic echocardiography of the heart
- non-invasive 24-hour blood pressure measurement by ABPM
- non-invasive 24-hour ECG recording using the Holter method
- non-invasive electrocardiographic exercise test on a treadmill and / or a six-minute walk test or other exercise test adequate to the patient's state of health; these tests will always be preceded by a detailed medical qualification
- assessment of the quality of the diet
- assessment of lifestyle, acceptance of disease and quality of life
- assessment of the psychological profile
Subsequently patients taking part in the prospective part of the study will perform a cardiac rehabilitation program.
After the cardiac rehabilitation program measurement procedures listed above (anthropometric measurements; ECG; non-invasive analysis of the body composition by bioimpedance; non-invasive measurement of resting blood pressure, resting heart rate and oxygen saturation of hemoglobin; non-invasive pulse wave analysis; non-invasive transthoracic echocardiography of the heart; non-invasive 24-hour blood pressure measurement by ABPM; non-invasive 24-hour ECG recording using the Holter method; non-invasive electrocardiographic exercise test; assessment of the quality of the diet; assessment of lifestyle, acceptance of disease and quality of life; assessment of the psychological profile) will be repeated.
Before and after the cardiac rehabilitation program blood samples, urine samples and hair samples will be collected. Blood samples, urine samples and hair samples will also be collected from patients taking part in the retrospective part of the study.
After data collection statistical analyses will be performed.
Дати
| Последна проверка: | 03/31/2020 |
| Първо изпратено: | 04/25/2019 |
| Очаквано записване подадено: | 04/30/2019 |
| Първо публикувано: | 05/01/2019 |
| Изпратена последна актуализация: | 04/27/2020 |
| Последна актуализация публикувана: | 04/28/2020 |
| Действителна начална дата на проучването: | 04/11/2019 |
| Приблизителна дата на първично завършване: | 12/30/2024 |
| Очаквана дата на завършване на проучването: | 12/30/2024 |
Състояние или заболяване
Интервенция / лечение
Other: Patients after ACS
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Patients after ACS Patients after acute coronary syndrome undergoing cardiac rehabilitation. | Other: Patients after ACS The training program of cardiac rehabilitation, depending on the results of the patient's medical qualification, will consist of the following: free active exercises, isometric exercises, active exercises in relief with resistance, isotonic exercises, isokinetic exercises, active breathing exercises, active breathing exercises with resistance, balance exercises, general exercises- individual and in groups, interval training on a treadmill or cycling cycloergometer, continuous training on a treadmill or cycling cycloergometer, circuit training, walking training, march training with accessories, autogenic training, walking. The training program will last an average 2 weeks. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Informed consent in writing - Coronary heart disease, a state after an acute coronary syndrome - Female or male - Age 18 - 99 years Exclusion Criteria: - Active neoplastic disease - Alcohol abuse, drug abuse - Pregnancy, lactation - Other conditions that in the opinion of researchers may pose any risk to the patient during the study. |
Резултат
Първични изходни мерки
1. Pulse wave velocity (PWV) I [At baseline]
2. PWV II [After intervention completion- an average of 2 weeks from baseline]
Вторични изходни мерки
1. Aortic pressure (AP) I [At baseline]
2. AP II [After intervention completion- an average of 2 weeks from baseline]
3. Body mass (BM) I [At baseline]
4. BM II [After intervention completion- an average of 2 weeks from baseline]
5. Body height (BH) I [At baseline]
6. BH II [After intervention completion- an average of 2 weeks from baseline]
7. Body mass index (BMI) I [At baseline]
8. BMI II [After intervention completion- an average of 2 weeks from baseline]
9. Waist circumference (WC) I [At baseline]
10. WC II [After intervention completion- an average of 2 weeks from baseline]
11. Hip circumference (HC) I [At baseline]
12. HC II [After intervention completion- an average of 2 weeks from baseline]
13. Neck circumference (NC) I [At baseline]
14. NC II [After intervention completion- an average of 2 weeks from baseline]
15. Total fat percentage (TF%) I [At baseline]
16. TF% II [After intervention completion- an average of 2 weeks from baseline]
17. Systolic blood pressure (SBP) I [At baseline]
18. SBP II [After intervention completion- an average of 2 weeks from baseline]
19. Diastolic blood pressure (DBP) I [At baseline]
20. DBP II [After intervention completion- an average of 2 weeks from baseline]
21. Heart rate (HR) I [At baseline]
22. HR II [After intervention completion- an average of 2 weeks from baseline]
23. Blood oxygen saturation (SO2) I [At baseline]
24. SO2 II [After intervention completion- an average of 2 weeks from baseline]
25. Ejection fraction (EF) I [At baseline]
26. EF II [After intervention completion- an average of 2 weeks from baseline]
27. Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I [At baseline]
28. ABPM SBP II [After intervention completion- an average of 2 weeks from baseline]
29. Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I [At baseline]
30. ABPM DBP II [After intervention completion- an average of 2 weeks from baseline]
31. Metabolic equivalent (MET) I [At baseline]
32. MET II [After intervention completion- an average of 2 weeks from baseline]
33. Distance in 6-minutes walk (6MW-D) I [At baseline]
34. 6MW-D II [After intervention completion- an average of 2 weeks from baseline]
35. aspartate aminotransferase (AST) I [At baseline]
36. AST II [After intervention completion- an average of 2 weeks from baseline]
37. alanine aminotransferase (ALT) I [At baseline]
38. ALT II [After intervention completion- an average of 2 weeks from baseline]
39. total bilirubin (TB) I [At baseline]
40. TB II [After intervention completion- an average of 2 weeks from baseline]
41. indirect bilirubin (IB) I [At baseline]
42. IB II [After intervention completion- an average of 2 weeks from baseline]
43. direct bilirubin (DB) I [At baseline]
44. DB II [After intervention completion- an average of 2 weeks from baseline]
45. gamma-glutamyltransferase (GGTP) I [At baseline]
46. GGTP II [After intervention completion- an average of 2 weeks from baseline]
47. total cholesterol (TCH) I [At baseline]
48. TCH II [After intervention completion- an average of 2 weeks from baseline]
49. low density lipoprotein (LDL) I [At baseline]
50. LDL II [After intervention completion- an average of 2 weeks from baseline]
51. high density lipoprotein (HDL) I [At baseline]
52. HDL II [After intervention completion- an average of 2 weeks from baseline]
53. triglycerides (TG) I [At baseline]
54. TG II [After intervention completion- an average of 2 weeks from baseline]
55. apolipoprotein A (ApoA) I [At baseline]
56. ApoA II [After intervention completion- an average of 2 weeks from baseline]
57. insulin (INS) I [At baseline]
58. INS II [After intervention completion- an average of 2 weeks from baseline]
59. glucose (GLU) I [At baseline]
60. GLU II [After intervention completion- an average of 2 weeks from baseline]
61. creatinine (CREA) I [At baseline]
62. CREA II [After intervention completion- an average of 2 weeks from baseline]
63. C-reactive protein (CRP) I [At baseline]
64. CRP II [After intervention completion- an average of 2 weeks from baseline]
65. adropin (ADR) I [At baseline]
66. ADR II [After intervention completion- an average of 2 weeks from baseline]
67. neopterin (NEOPT) I [At baseline]
68. NEOPT II [After intervention completion- an average of 2 weeks from baseline]
69. N-terminal natriuretic propeptide type B (NTpro-BNP) I [At baseline]
70. NTpro-BNP II [After intervention completion- an average of 2 weeks from baseline]
71. magnesium (Mg) I [At baseline]
72. Mg II [After intervention completion- an average of 2 weeks from baseline]
73. homocysteine (Hcy) I [At baseline]
74. Hcy II [After intervention completion- an average of 2 weeks from baseline]
75. troponin (TROP) I [At baseline]
76. TROP II [After intervention completion- an average of 2 weeks from baseline]
77. interleukin 6 (IL6) I [At baseline]
78. IL6 II [After intervention completion- an average of 2 weeks from baseline]
79. tumor necrosis factor (TNF) I [At baseline]
80. TNF II [After intervention completion- an average of 2 weeks from baseline]
81. vascular endothelial growth factor (VEGF) I [At baseline]
82. VEGF II [After intervention completion- an average of 2 weeks from baseline]
83. leptin (LPT) I [At baseline]
84. LPT II [After intervention completion- an average of 2 weeks from baseline]
85. VEGF polymorphism [At baseline]
86. Urine concentration of magnesium (U-Mg) I [At baseline]
87. U-Mg II [After intervention completion- an average of 2 weeks from baseline]
88. Hair content of magnesium (H-Mg) I [At baseline]
89. H-Mg II [After intervention completion- an average of 2 weeks from baseline]
