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IRCT20221227056940N1 IRCT 2024-09-21 Shahroud University of Medical Sciences The effect of physical activity on blood sugar control in patients with type 2 diabetes The effect of written prescription of physical activity program on blood sugar control in patients with type 2 diabetes, a randomized clinical trial 2024-10-06 anticipated 100 Complete https://irct.ir/trial/78785 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: use block. Random unit: individual. ŮŽRandomization tool: An online randomization website. Sequence building: using block randomization method with block size of 4. Concealing method: using closed and opaque envelopes, Blinding description: In this study, clinical evaluator and analyzer are blinded. The allocation of patients into two groups A and B is done by a experienced person who has no aware of the actions performed in the two groups. Clinical examination and outcome evaluation will be record by a qualified person without any information about the type of intervention. 2-3 Type 2 diabetes. Intervention 1: Intervention group: after justifying the patients and providing the necessary training, in addition to the routine treatment program (including prescribing medicine (if needed), giving verbal advice on following dietary instructions and having regular physical activity 150 minutes per week), a written prescription to perform Regular walking will be prescribed for 150 minutes of walking per week (as desired in the morning or evening and preferably divided into weekdays). Intervention 2: Control group: after justifying the patients and providing the necessary training, a routine treatment program (including prescribing medicine (if needed), giving verbal advice on following dietary instructions and having regular physical activity 150 minutes per week) will be prescribed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the completion of the study, a decision will be made in consultation with the moderators.
public Seyd Mostafa Alavi
Imam Hossein Hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 mostafa.casillas3@gmail.com Shahroud University of Medical Sciences scientific Dr. Tahereh Jalali
Imam Hossein Hospital., End Imam street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 t.jalali.95@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Patients with a definitive diagnosis of type 2 diabetes; type 2 diabetic patients need therapeutic interventions; having stable vital signs; age range between 15 and 65 years; having informed consent to participate in the research. 15 years 65 years Both Diabetic people who need hospitalization; the presence of communication or cognitive disorders in patients; inability to perform physical activities in patients; the presence of severe and advanced heart and lung diseases in patients; the presence of severe skeletal and muscular disease in patients; regret or withdrawal from continuing the research. E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Intervention group: after justifying the patients and providing the necessary training, in addition to the routine treatment program (including prescribing medicine (if needed), giving verbal advice on following dietary instructions and having regular physical activity 150 minutes per week), a written prescription to perform Regular walking will be prescribed for 150 minutes of walking per week (as desired in the morning or evening and preferably divided into weekdays). Control group: after justifying the patients and providing the necessary training, a routine treatment program (including prescribing medicine (if needed), giving verbal advice on following dietary instructions and having regular physical activity 150 minutes per week) will be prescribed. Measuring fasting blood sugar. Timepoint: At monthly intervals from the beginning of the study until 3 months after intervention. Method of measurement: By standard laboratory method. Measuring 2-hours blood sugar. Timepoint: At monthly intervals from the beginning of the study until 3 months after intervention. Method of measurement: By standard laboratory method. Measurement of Glycosylated Hemoglobin (A1c). Timepoint: At the beginning of the study and 3 months after the intervention. Method of measurement: By standard laboratory method. Measurement of systemic blood pressure. Timepoint: At monthly intervals from the beginning of the study until 3 months after intervention. Method of measurement: In a standard way and with a Mercury sphygmomanometer. Body weight measurement. Timepoint: At monthly intervals from the beginning of the study until 3 months after intervention. Method of measurement: In a standard way and with a digital scale device. Shahroud University of Medical Sciences Approved 2022-10-12 Shahroud University of Medical Sciences Shahroud University of Medical Sciences; 7 Tir squer, Shahroud Shahroud Semnan Iran (Islamic Republic of)