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Developing a Method of Rehabilitation for Patients After Myocardial Revascularization

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05306119
Enrollment
120
Registered
2022-03-31
Start date
2021-07-01
Completion date
2026-06-30
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Rehabilitation, Revascularization

Keywords

Rehabilitation, Revascularization, Low back pain, myocardial revascularization

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.

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.

Interventions

OTHERRehabilitation 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.

Sponsors

Gomel State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Prospective cohort study

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Work capacity21 days after intervention of rehabilitation methodVisual 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
Blood pressure level21 days after intervention of rehabilitation methodSystolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg)
Mobility21 days after intervention of rehabilitation methodVisual 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
Self-service21 days after intervention of rehabilitation methodSelf-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.
Back pain21 days after intervention of rehabilitation methodSelf-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.
Heartache21 days after intervention of rehabilitation methodSelf-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.
Angina pectoris21 days after intervention of rehabilitation methodECG. Reveal the signs of ischemia (deviation of ST segment).
Arrhythmia21 days after intervention of rehabilitation methodHolter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.
Exercise tolerance21 days after intervention of rehabilitation methodTreadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.
Paresis21 days after intervention of rehabilitation methodVisual 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

MeasureTime frameDescription
Acute myocardial infarction21 days after intervention of rehabilitation methodIncreasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report).
Death due to vascular diseases21 days after intervention of rehabilitation methodThe 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.
Stroke21 days after intervention of rehabilitation methodSCORE 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.

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026