RehabilitationNCT05306119
Developing a Method of Rehabilitation for Patients After Myocardial Revascularization
A study testing Rehabilitation method in people with Rehabilitation and Low Back Pain, run by Gomel State Medical University at 1 site in Belarus.
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… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Low Back Pain, Revascularization
- What is being tested?
- Rehabilitation method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients After Myocardial Revascularization Combined With Low Back Pain of 40-60 years of age
Who cannot join
- Arterial hypertension
- Heart attack
- Atherosclerosis
- Stroke
- Coronary heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Method of Rehabilitation for Patients After Myocardial Revascularization Combined With Low Back Pain and Criteria for Evaluating Its Effectiveness
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.
Read the 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:
- 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.
- Conditions
- Rehabilitation, Low Back Pain, Revascularization
- Being tested
- Rehabilitation method
- Keywords
- Rehabilitation, Revascularization, Low back pain, myocardial revascularization
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation methodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Main group | Active comparator | 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 Receives: Other: Rehabilitation method |
| Comparison group | No intervention | 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 |
| Control group | No intervention | Healthy people aged 40-60 y.o. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 21 days after intervention of rehabilitation method
Angina pectoris
ECG. Reveal the signs of ischemia (deviation of ST segment).
Measured: 21 days after intervention of rehabilitation method
Arrhythmia
Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.
Measured: 21 days after intervention of rehabilitation method
Exercise tolerance
Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months after intervention of rehabilitation method
Angina pectoris
ECG. ECG. Reveal the signs of ischemia (deviation of ST segment).
Measured: 6 months after intervention of rehabilitation method
Arrhythmia
Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.
Measured: 6 months after intervention of rehabilitation method
Exercise tolerance
Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 year after intervention of rehabilitation method
Angina pectoris
ECG. Reveal the signs of ischemia (deviation of ST segment).
Measured: 1 year after intervention of rehabilitation method
Arrhythmia
Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.
Measured: 1 year after intervention of rehabilitation method
Exercise tolerance
Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 1 year after intervention of rehabilitation method
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 1 year after intervention of rehabilitation method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jul 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gomel State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalliya Halinouskaya, Proff, Study director, Gomel State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306119
- Sponsor's protocol ID
- 20213753
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Method of Rehabilitation for Patients After Myocardial Revascularization Combined With Low Back Pain and Criteria for Evaluating Its Effectiveness
- ClinicalTrials.gov ID
- NCT05306119
- Acronym / sponsor ID
- 20213753
- Conditions
- Rehabilitation, Low Back Pain, Revascularization
- Keywords
- Rehabilitation, Revascularization, Low back pain, myocardial revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gomel State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Main group | Active comparator | Other: Rehabilitation methodPatients 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 |
| Comparison group | No intervention | –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 |
| Control group | No intervention | –Healthy people aged 40-60 y.o. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients After Myocardial Revascularization Combined With Low Back Pain of 40-60 years of age
Key exclusion criteria (5 listed)
- Arterial hypertension
- Heart attack
- Atherosclerosis
- Stroke
- Coronary heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation methodApplication of techniques of kinesiotherapy, electrotherapy, massage in comorbid patients and patients with low back pain who had undergone myocardial revascularization surgery in main group. | Other | Main group |
Primary outcome
Back pain
Time frame: 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.
Heartache
Time frame: 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.
Angina pectoris
Time frame: 21 days after intervention of rehabilitation method
ECG. Reveal the signs of ischemia (deviation of ST segment).
Arrhythmia
Time frame: 21 days after intervention of rehabilitation method
Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.
Exercise tolerance
Time frame: 21 days after intervention of rehabilitation method
Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.
Paresis
Time frame: 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
Blood pressure level
Time frame: 21 days after intervention of rehabilitation method
Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg)
Mobility
Time frame: 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
Self-service
Time frame: 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.
Work capacity
Time frame: 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
Back pain
Time frame: 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.
Heartache
Time frame: 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.
Angina pectoris
Time frame: 6 months after intervention of rehabilitation method
ECG. ECG. Reveal the signs of ischemia (deviation of ST segment).
Arrhythmia
Time frame: 6 months after intervention of rehabilitation method
Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.
Exercise tolerance
Time frame: 6 months after intervention of rehabilitation method
Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.
Paresis
Time frame: 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
Blood pressure level
Time frame: 6 months after intervention of rehabilitation method
Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg)
Mobility
Time frame: 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
Self-service
Time frame: 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.
Work capacity
Time frame: 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
Back pain
Time frame: 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.
Heartache
Time frame: 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.
Angina pectoris
Time frame: 1 year after intervention of rehabilitation method
ECG. Reveal the signs of ischemia (deviation of ST segment).
Arrhythmia
Time frame: 1 year after intervention of rehabilitation method
Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia.
Exercise tolerance
Time frame: 1 year after intervention of rehabilitation method
Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve.
Paresis
Time frame: 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
Blood pressure level
Time frame: 1 year after intervention of rehabilitation method
Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg)
Mobility
Time frame: 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
Self-service
Time frame: 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.
Work capacity
Time frame: 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
9 secondary outcomes
Stroke
Time frame: 21 days after intervention of rehabilitation method
Acute myocardial infarction
Time frame: 21 days after intervention of rehabilitation method
Death due to vascular diseases
Time frame: 21 days after intervention of rehabilitation method
Stroke
Time frame: 6 months after intervention of rehabilitation method
Acute myocardial infarction
Time frame: 6 months after intervention of rehabilitation method
Death due to vascular diseases
Time frame: 6 months after intervention of rehabilitation method
Stroke
Time frame: 1 year after intervention of rehabilitation method
Acute myocardial infarction
Time frame: 1 year after intervention of rehabilitation method
Death due to vascular diseases
Time frame: 1 year after intervention of rehabilitation method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalliya Halinouskaya, Proff study director
Gomel State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation method in people with Rehabilitation and Low Back Pain, run by Gomel State Medical University at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain (time frame: 21 days after intervention of rehabilitation method). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.