Clinical trial NCT05306119: Developing a Method of Rehabilitation for Patients After Myocardial Revascularization
Official title: Developing a Method of Rehabilitation for Patients After Myocardial Revascularization Combined With Low Back Pain and Criteria for Evaluating Its Effectiveness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rehabilitation
Low Back Pain
Revascularization
Keywords: Rehabilitation
Revascularization
Low back pain
myocardial revascularization
Lead sponsor: Gomel State Medical University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Back pain
timeFrame: 21 days after intervention of rehabilitation method
measure: Heartache
timeFrame: 21 days after intervention of rehabilitation method
measure: Angina pectoris
timeFrame: 21 days after intervention of rehabilitation method
measure: Arrhythmia
timeFrame: 21 days after intervention of rehabilitation method
measure: Exercise tolerance
timeFrame: 21 days after intervention of rehabilitation method
measure: Paresis
timeFrame: 21 days after intervention of rehabilitation method
measure: Blood pressure level
timeFrame: 21 days after intervention of rehabilitation method
measure: Mobility
timeFrame: 21 days after intervention of rehabilitation method
measure: Self-service
timeFrame: 21 days after intervention of rehabilitation method
measure: Work capacity
timeFrame: 21 days after intervention of rehabilitation method
measure: Back pain
timeFrame: 6 months after intervention of rehabilitation method
measure: Heartache
timeFrame: 6 months after intervention of rehabilitation method
measure: Angina pectoris
timeFrame: 6 months after intervention of rehabilitation method
measure: Arrhythmia
timeFrame: 6 months after intervention of rehabilitation method
measure: Exercise tolerance
timeFrame: 6 months after intervention of rehabilitation method
measure: Paresis
timeFrame: 6 months after intervention of rehabilitation method
measure: Blood pressure level
timeFrame: 6 months after intervention of rehabilitation method
measure: Mobility
timeFrame: 6 months after intervention of rehabilitation method
measure: Self-service
timeFrame: 6 months after intervention of rehabilitation method
measure: Work capacity
timeFrame: 6 months after intervention of rehabilitation method
measure: Back pain
timeFrame: 1 year after intervention of rehabilitation method
measure: Heartache
timeFrame: 1 year after intervention of rehabilitation method
measure: Angina pectoris
timeFrame: 1 year after intervention of rehabilitation method
measure: Arrhythmia
timeFrame: 1 year after intervention of rehabilitation method
measure: Exercise tolerance
timeFrame: 1 year after intervention of rehabilitation method
measure: Paresis
timeFrame: 1 year after intervention of rehabilitation method
measure: Blood pressure level
timeFrame: 1 year after intervention of rehabilitation method
measure: Mobility
timeFrame: 1 year after intervention of rehabilitation method
measure: Self-service
timeFrame: 1 year after intervention of rehabilitation method
measure: Work capacity
timeFrame: 1 year after intervention of rehabilitation method
Secondary outcomes:
measure: Stroke
timeFrame: 21 days after intervention of rehabilitation method
measure: Acute myocardial infarction
timeFrame: 21 days after intervention of rehabilitation method
measure: Death due to vascular diseases
timeFrame: 21 days after intervention of rehabilitation method
measure: Stroke
timeFrame: 6 months after intervention of rehabilitation method
measure: Acute myocardial infarction
timeFrame: 6 months after intervention of rehabilitation method
measure: Death due to vascular diseases
timeFrame: 6 months after intervention of rehabilitation method
measure: Stroke
timeFrame: 1 year after intervention of rehabilitation method
measure: Acute myocardial infarction
timeFrame: 1 year after intervention of rehabilitation method
measure: Death due to vascular diseases
timeFrame: 1 year after intervention of rehabilitation method
Other outcomes:
Locations:
city: Gomel
country: Belarus
facility: Gomel State Medical University
state: Province
Study officials:
affiliation: Gomel State Medical University
name: Natalliya Halinouskaya, Proff
role: STUDY_DIRECTOR
References: