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IRCT20130816014371N3 IRCT 2022-12-09 Tabriz University of Medical Sciences Effect of combined exercises (stretching, voluntary balance coordination, aerobic, resistance) along with soy milk supplement on performance, trunk -control-movement, daily life activities, electrolyte balance, ischemic lesion volume and cognitive complication in stroke patients. Effect of combined exercises (stretching, voluntary balance coordination, aerobic, resistance) along with soy milk supplement on performance, trunk -control-movement, daily life activities, electrolyte balance, ischemic lesion volume and cognitive complication in stroke patients. 2022-12-15 anticipated 120 Complete https://irct.ir/trial/67293 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The random sequence of allocation by a person not involved in the research using RAS (Random Allocation Software) and random block design using blocks of three and six for allocation in three groups: intervention group 1, intervention group 2 and control (production) will be done. Allocation concealment will be done based on the sequence produced by using opaque, closed and identical envelopes numbered from number 1 to the end. The first person who enters the study will be given envelope number 1 and This process will continue until the end, so the researcher and the researched person will not know the type of Allocation Concealment received until after the envelopes are opened. In this study, the patients will be the ones filling the questionnaire, the statistical analyzer and the outcome examiner will be blinded. Sufficient information about the objectives of the research and its importance is given to the participants and they are assured about the confidentiality of their personal information, Blinding description: In this study, the patients will be the ones filling the questionnaire, the statistical analyzer and the outcome examiner will be blinded. Sufficient information about the objectives of the research and its importance is given to the participants and they are assured about the confidentiality of their personal information. Patients will not be informed about the type of exercises received, and because their hospital room is separate, they will not imitate each other's movements. 4 STROKE. Intervention 1: Intervention group: Training group (receiving combined sports training) [TG],. Intervention 2: Intervention group: Exercise group + supplement (receive combined exercise + soy milk supplement) [TS]. Intervention 3: Intervention group: Supplement group (receiving routine hospital activity + soy milk supplement)[SG]. Intervention 4: Control group: Control (receipt of hospital routine activity). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts 6 months after the results are published To whom: All researchers Conditions: For similar studies to consolidate the results Where to obtain: To the responsible person's email How to obtain: To the responsible person's email Comments:
public dr. Vahid sarraf
Golgasht
Tabriz Iran (Islamic Republic of) 5155676934 +98 41 3334 7054 sarraf@tabrizu.ac.ir Tabriz University of Medical Sciences scientific Dr.vahid sarraf
Golgasht
Tabriz Iran (Islamic Republic of) 5155676934 +98 41 3334 7054 sarraf@tabrizu.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of stroke by physician consciousness level 14 to 16 based on Four Score NIHSS score 5-15 (National Institutes of Health Stroke Scale) no TPA no aphasia (based on (NIHSS criteria, stable vital signs) systolic blood pressure above 90 mmHg, heart rate above 40 and oxygen saturation above 94%) absence of significant fractures and orthopedic defects in organs absence of acute coronary syndrome respiratory failure or heart failure based on hospital records absence of conditions life-threatening such as having cardiac arrhythmia or receiving inotrope drugs (dopamine, dobuitamin) absence of restriction of movement so that the participant can raise his hand to the table paresis or unilateral body paralysis inactive range of motion at least 90 degrees for abduction shoulder and elbow flexion and 30 degrees for the wrist 25 years 65 years Both Overt heart disease such as heart failure, angina pectoris, myocardial infarction within 120 days prior to the intervention, cardiomyopathy, or severe cardiac arrhythmia inflammation or infection muscular dystrophy, myasthenia gravis I69.4 I69.4 Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group: Training group (receiving combined sports training) [TG], Intervention group: Exercise group + supplement (receive combined exercise + soy milk supplement) [TS] Intervention group: Supplement group (receiving routine hospital activity + soy milk supplement)[SG] Control group: Control (receipt of hospital routine activity) BALANCE. Timepoint: Before the intervention and 1, 2, 3, 4 weeks after the intervention. Method of measurement: through a questionnaire. MORITCITY AND MOBILBITY. Timepoint: Before the intervention and 1, 2, 3, 4 weeks after the intervention. Method of measurement: through a questionnaire. TRUNK CONTROL. Timepoint: Before the intervention and 1, 2, 3, 4 weeks after the intervention. Method of measurement: through a questionnaire. Ability to perform daily tasks. Timepoint: Before the intervention and 1, 2, 3, 4 weeks after the intervention. Method of measurement: through a questionnaire. Electrolytic changes. Timepoint: Before the intervention and 1, 2, 3, 4 weeks after the intervention. Method of measurement: through blood sample analysis. Ischemic lesion volume and cognitive status. Timepoint: Before the intervention and 1, 2, 3, 4 weeks after the intervention: for the cognitive status and size of the lesion before and after the last intervention. Method of measurement: Through a questionnaire: cognitive status and examination of patients' scans: the size of the lesion. Tabriz University of Medical Sciences Approved 2022-10-18 Tabriz university Golgasht Street, Imam Reza Hospital Tabriz East Azarbaijan Iran (Islamic Republic of)