Developing a Method of Rehabilitation for Patients After Myocardial Revascularization

Sponsor
Gomel State Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05306119
Collaborator
(none)
120
1
3
60
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation method
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective cohort studyProspective cohort study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Developing a Method of Rehabilitation for Patients After Myocardial Revascularization Combined With Low Back Pain and Criteria for Evaluating Its Effectiveness
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Main group

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
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.

No Intervention: Comparison group

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

Healthy people aged 40-60 y.o.

Outcome Measures

Primary Outcome Measures

  1. Back pain [21 days after intervention of rehabilitation method]

    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.

  2. Heartache [21 days after intervention of rehabilitation method]

    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.

  3. Angina pectoris [21 days after intervention of rehabilitation method]

    ECG. Reveal the signs of ischemia (deviation of ST segment).

  4. Arrhythmia [21 days after intervention of rehabilitation method]

    Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.

  5. Exercise tolerance [21 days after intervention of rehabilitation method]

    Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.

  6. Paresis [21 days after intervention of rehabilitation method]

    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

  7. Blood pressure level [21 days after intervention of rehabilitation method]

    Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg)

  8. Mobility [21 days after intervention of rehabilitation method]

    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

  9. Self-service [21 days after intervention of rehabilitation method]

    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.

  10. Work capacity [21 days after intervention of rehabilitation method]

    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

  11. Back pain [6 months after intervention of rehabilitation method]

    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.

  12. Heartache [6 months after intervention of rehabilitation method]

    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.

  13. Angina pectoris [6 months after intervention of rehabilitation method]

    ECG. ECG. Reveal the signs of ischemia (deviation of ST segment).

  14. Arrhythmia [6 months after intervention of rehabilitation method]

    Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.

  15. Exercise tolerance [6 months after intervention of rehabilitation method]

    Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.

  16. Paresis [6 months after intervention of rehabilitation method]

    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

  17. Blood pressure level [6 months after intervention of rehabilitation method]

    Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg)

  18. Mobility [6 months after intervention of rehabilitation method]

    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

  19. Self-service [6 months after intervention of rehabilitation method]

    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.

  20. Work capacity [6 months after intervention of rehabilitation method]

    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. Back pain [1 year after intervention of rehabilitation method]

    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.

  22. Heartache [1 year after intervention of rehabilitation method]

    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.

  23. Angina pectoris [1 year after intervention of rehabilitation method]

    ECG. Reveal the signs of ischemia (deviation of ST segment).

  24. Arrhythmia [1 year after intervention of rehabilitation method]

    Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.

  25. Exercise tolerance [1 year after intervention of rehabilitation method]

    Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.

  26. Paresis [1 year after intervention of rehabilitation method]

    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

  27. Blood pressure level [1 year after intervention of rehabilitation method]

    Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg)

  28. Mobility [1 year after intervention of rehabilitation method]

    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

  29. Self-service [1 year after intervention of rehabilitation method]

    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.

  30. Work capacity [1 year after intervention of rehabilitation method]

    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

Secondary Outcome Measures

  1. Stroke [21 days after intervention of rehabilitation method]

    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.

  2. Acute myocardial infarction [21 days after intervention of rehabilitation method]

    Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report).

  3. Death due to vascular diseases [21 days after intervention of rehabilitation method]

    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.

  4. Stroke [6 months after intervention of rehabilitation method]

    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.

  5. Acute myocardial infarction [6 months after intervention of rehabilitation method]

    Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report).

  6. Death due to vascular diseases [6 months after intervention of rehabilitation method]

    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.

  7. Stroke [1 year after intervention of rehabilitation method]

    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.

  8. Acute myocardial infarction [1 year after intervention of rehabilitation method]

    Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report).

  9. Death due to vascular diseases [1 year after intervention of rehabilitation method]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gomel State Medical University Gomel Province Belarus 246000

Sponsors and Collaborators

  • Gomel State Medical University

Investigators

  • Study Director: Natalliya Halinouskaya, Proff, Gomel State Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gomel State Medical University
ClinicalTrials.gov Identifier:
NCT05306119
Other Study ID Numbers:
  • 20213753
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gomel State Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022