Developing a Method of Rehabilitation for Patients After Myocardial Revascularization

Study Overview
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Brief Summary
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As a result, will be developed: a list of criteria for functional impairment in patients after myocardial revascularization combined with low back pain; a list of criteria for disabilities in patients after myocardial revascularization combined with low back pain; method of medical rehabilitation of patients after myocardial revascularization combined with low back pain; and criteria for evaluating its effectiveness.

Detailed Description
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Aim: to improve the quality of medical rehabilitation of patients after myocardial revascularization combined with low back pain by developing the method of medical rehabilitation with evaluating its effectiveness. Objectives: To exam clinical and functional state assessment of patients after myocardial revascularization combined with low back pain. To analyze functional status of patients after myocardial revascularization combined with low back pain, who were admitted for medical rehabilitation and determine a list of criteria of impaired functions and a list of criteria for life limitation in patients after myocardial revascularization combined with low back pain. To develop an algorithm for assessing patients' functional status after myocardial revascularization combined with low back pain. To analyze of the effect of different means and methods of rehabilitation in comorbid patients after myocardial revascularization combined with low back pain: the degree of severity of pain syndrome, limitation of mobility, ability to self-care. To develop the Draft Electronic Medical Rehabilitation Card of a patient (a medical rehabilitation card of a standard pattern). Choose the most effective techniques of medical rehabilitation, determining the efficiency of performed of medical rehabilitation measures in patients after myocardial revascularization combined with low back pain and form a list of medical rehabilitation measures in these patients. To evaluate the effectiveness of medical rehabilitation in patients after myocardial revascularization combined with low back pain and list of them. To develop a method of medical rehabilitation of patients after myocardial revascularization combined with low back pain. Evaluate the effectiveness of the developed method of medical rehabilitation of patients after myocardial revascularization combined with low back pain in the medium term (in the period of 6 months, 1 year after the end of rehabilitation). To evaluate the effectiveness of medical rehabilitation of patients after myocardial revascularization combined with low back pain and approve the developed indicators in order to evaluate the efficiency of medical rehabilitation in this group of patients. To develop an instruction manual containing a method of medical rehabilitation in patients after myocardial revascularization combined with low back pain and criteria for assessing its effectiveness.

Official Title
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Developing a Method of Rehabilitation for Patients After Myocardial Revascularization Combined With Low Back Pain and Criteria for Evaluating Its Effectiveness

Conditions
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Low Back Pain, Rehabilitation, Revascularization

Intervention / Treatment
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* Other: Rehabilitation method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients After Myocardial Revascularization Combined With Low Back Pain of 40-60 years of age Exclusion Criteria: Arterial hypertension Heart attack Atherosclerosis Stroke Coronary heart disease

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Main group<br>Patients with low back pain who had undergone myocardial revascularization surgery within a year prior to admission to a sanatorium organization, admitted for a course of sanatorium treatment with an individual program of medical rehabilitation with the use of means, affecting both diseases lasting up to 21 days | Other: Rehabilitation method<br>* Application of techniques of kinesiotherapy, electrotherapy, massage in comorbid patients and patients with low back pain who had undergone myocardial revascularization surgery in main group.<br>|
| No Intervention: Comparison group<br>Patients with low back pain who had undergone myocardial revascularization surgery within a year prior to admission to a sanatorium organization, admitted for a course of sanatorium treatment lasting up to 21 days | |
| No Intervention: Control group<br>Healthy people aged 40-60 y.o. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 21 days after intervention of rehabilitation method | 
| Heartache | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 21 days after intervention of rehabilitation method | 
| Angina pectoris | ECG. Reveal the signs of ischemia (deviation of ST segment). | 21 days after intervention of rehabilitation method | 
| Arrhythmia | Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia. | 21 days after intervention of rehabilitation method | 
| Exercise tolerance | Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve. | 21 days after intervention of rehabilitation method | 
| Paresis | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 21 days after intervention of rehabilitation method | 
| Blood pressure level | Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg) | 21 days after intervention of rehabilitation method | 
| Mobility | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 21 days after intervention of rehabilitation method | 
| Self-service | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 21 days after intervention of rehabilitation method | 
| Work capacity | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 21 days after intervention of rehabilitation method | 
| Back pain | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 6 months after intervention of rehabilitation method | 
| Heartache | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 6 months after intervention of rehabilitation method | 
| Angina pectoris | ECG. ECG. Reveal the signs of ischemia (deviation of ST segment). | 6 months after intervention of rehabilitation method | 
| Arrhythmia | Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia. | 6 months after intervention of rehabilitation method | 
| Exercise tolerance | Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve. | 6 months after intervention of rehabilitation method | 
| Paresis | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 6 months after intervention of rehabilitation method | 
| Blood pressure level | Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg) | 6 months after intervention of rehabilitation method | 
| Mobility | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 6 months after intervention of rehabilitation method | 
| Self-service | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 6 months after intervention of rehabilitation method | 
| Work capacity | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 6 months after intervention of rehabilitation method | 
| Back pain | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 1 year after intervention of rehabilitation method | 
| Heartache | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 1 year after intervention of rehabilitation method | 
| Angina pectoris | ECG. Reveal the signs of ischemia (deviation of ST segment). | 1 year after intervention of rehabilitation method | 
| Arrhythmia | Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia. | 1 year after intervention of rehabilitation method | 
| Exercise tolerance | Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve. | 1 year after intervention of rehabilitation method | 
| Paresis | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 1 year after intervention of rehabilitation method | 
| Blood pressure level | Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg) | 1 year after intervention of rehabilitation method | 
| Mobility | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 1 year after intervention of rehabilitation method | 
| Self-service | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. | 1 year after intervention of rehabilitation method | 
| Work capacity | Visual examination with a determination of a degree The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance | 1 year after intervention of rehabilitation method | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | SCORE 2 chart Risk assessment of cardiovascular accidents. A scale for assessing the risk of death due to cardiovascular disease within 10 years. Assessment is based on the age, sex, systolic pressure (mm.Hg), cholesterol level (mmol/l), smoking status. Scores: < 1%, 1%, 2 %, 3-4 %, 5-9 %, 10-14 %, 15% and over. | 21 days after intervention of rehabilitation method | 
| Acute myocardial infarction | Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report). | 21 days after intervention of rehabilitation method | 
| Death due to vascular diseases | The Lown grading system for ventricular arrhythmias of high rank The Lown grading system is used in observational and experimental studies of ischaemic heart disease. This grading system uses three levels of ventricular premature depolarisation frequency and four complex features to assign patients to one of seven grades. Assessment occurs depending on the number and type of extrasystoles according to Holter monitoring data. Grades: 0, 1, 2, 3A, 3B, 4A, 4B, 5. | 21 days after intervention of rehabilitation method | 
| Stroke | SCORE 2 chart Risk assessment of cardiovascular accidents. A scale for assessing the risk of death due to cardiovascular disease within 10 years. Assessment is based on the age, sex, systolic pressure (mm.Hg), cholesterol level (mmol/l), smoking status. Scores: < 1%, 1%, 2 %, 3-4 %, 5-9 %, 10-14 %, 15% and over. | 6 months after intervention of rehabilitation method | 
| Acute myocardial infarction | Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report). | 6 months after intervention of rehabilitation method | 
| Death due to vascular diseases | The Lown grading system for ventricular arrhythmias of high rank The Lown grading system is used in observational and experimental studies of ischaemic heart disease. This grading system uses three levels of ventricular premature depolarisation frequency and four complex features to assign patients to one of seven grades. Assessment occurs depending on the number and type of extrasystoles according to Holter monitoring data. Grades: 0, 1, 2, 3A, 3B, 4A, 4B, 5. | 6 months after intervention of rehabilitation method | 
| Stroke | SCORE 2 chart Risk assessment of cardiovascular accidents. A scale for assessing the risk of death due to cardiovascular disease within 10 years. Assessment is based on the age, sex, systolic pressure (mm.Hg), cholesterol level (mmol/l), smoking status. Scores: < 1%, 1%, 2 %, 3-4 %, 5-9 %, 10-14 %, 15% and over. | 1 year after intervention of rehabilitation method | 
| Acute myocardial infarction | Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report). | 1 year after intervention of rehabilitation method | 
| Death due to vascular diseases | The Lown grading system for ventricular arrhythmias of high rank The Lown grading system is used in observational and experimental studies of ischaemic heart disease. This grading system uses three levels of ventricular premature depolarisation frequency and four complex features to assign patients to one of seven grades. Assessment occurs depending on the number and type of extrasystoles according to Holter monitoring data. Grades: 0, 1, 2, 3A, 3B, 4A, 4B, 5. | 1 year after intervention of rehabilitation method | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Revascularization, Low back pain, myocardial revascularization