Developing a Method of Rehabilitation for Patients After Myocardial Revascularization

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05306119
• Other study ID #: 20213753
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2022
• Source: Gomel State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. To exam clinical and functional state assessment of patients after myocardial revascularization combined with low back pain.

2. 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.

3. To develop an algorithm for assessing patients' functional status after myocardial revascularization combined with low back pain.

4. 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.

5. To develop the Draft Electronic Medical Rehabilitation Card of a patient (a medical rehabilitation card of a standard pattern).

6. 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.

7. To evaluate the effectiveness of medical rehabilitation in patients after myocardial revascularization combined with low back pain and list of them.

8. To develop a method of medical rehabilitation of patients after myocardial revascularization combined with low back pain.

9. 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).

10. 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.

11. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Rehabilitation
• Revascularization

Intervention

Other:
• Rehabilitation method
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.

Locations

Country	Name	City	State
Belarus	Gomel State Medical University	Gomel	Province

Sponsors (1)

Lead Sponsor	Collaborator
Gomel State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Angina pectoris	ECG. Reveal the signs of ischemia (deviation of ST segment).	21 days after intervention of rehabilitation method
Primary	Arrhythmia	Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.	21 days after intervention of rehabilitation method
Primary	Exercise tolerance	Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.	21 days after intervention of rehabilitation method
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Angina pectoris	ECG. ECG. Reveal the signs of ischemia (deviation of ST segment).	6 months after intervention of rehabilitation method
Primary	Arrhythmia	Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.	6 months after intervention of rehabilitation method
Primary	Exercise tolerance	Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.	6 months after intervention of rehabilitation method
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Angina pectoris	ECG. Reveal the signs of ischemia (deviation of ST segment).	1 year after intervention of rehabilitation method
Primary	Arrhythmia	Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.	1 year after intervention of rehabilitation method
Primary	Exercise tolerance	Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.	1 year after intervention of rehabilitation method
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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