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IRCT20230429058020N1 IRCT 2023-05-07 Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran The effect of foot exercises on the pain of diabetic foot neuropathy Investigating The effect of foot exercise on the pain of diabetic foot neuropathy in the selected medical center affiliated to Tehran University of Medical Sciences in 2023 2023-05-02 anticipated 60 Complete https://irct.ir/trial/69830 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Sampling of this research is random and gradual, that is, qualified people will enter the research after knowing the steps and objectives of the research and completing the consent form if they have the conditions to enter and if they do not have the conditions to not enter the research. This sampling is gradual, that is, it is done during at least one week. Eligible samples will be divided into two control and test groups by simple random sampling method. Out of the clients on odd days, they are in the intervention group and the clients on even days are in the control group, Blinding description: The number of samples for the intervention group was 30 people and for the control group 30 people, which were randomly selected from among the clients. Out of the clients on odd days, they are in the intervention group and the clients on even days are in the control group. And in this way, people do not know that they are in the intervention or control group, and the researcher knows about the condition of the participants. N/A Diabetic neuropathy pain. Intervention 1: Intervention group: In the intervention group, after selecting the qualified samples and explaining about the research stages, the required concepts and the benefits of leg exercises and how to perform them, the patient's consent is obtained, and then after obtaining a written consent, in the same session, the personal information form and the questionnaire A summary of the pain intensity will be provided to the patient and after going through the above steps, for 12 consecutive weeks and three days a week between 8:00 and 13:00, one training set with 8-10 repetitions per hour individually for each person, in the bed. The patient performs leg exercises in the presence of the researcher, which will take 5-10 minutes. At home, these exercises should be performed 2-3 times a day, 10 repetitions each time, and the number of times will gradually increase, and the patients will be monitored and guided by phone calls at least once a week.Before and after performing leg exercises (before the intervention and then 12 weeks later), the patient's diabetes indicators (glycosylated hemoglobin, fasting blood sugar, blood sugar 2 hours after a meal and body mass index) are measured and recorded. Also, before and after the completion of 12 weeks, the patient's pain level is measured by a questionnaire. Intervention 2: Control group: In the control group, the patient's consent will be obtained after the necessary explanations about the research steps. Then, in the same meeting, the personal information form and the brief pain intensity questionnaire form will be completed by the patient. Patients in the control group will receive routine blood sugar control training. In the twelfth week of the visit, the pain assessment form will be provided to them again for completion. The diabetes indicators of the control group patients will be measured and recorded in the same time intervals and exactly at the same time of the day and night (similar to the intervention group), pain and disease symptoms for 12 weeks as the first appointment (first session) and after 12 weeks. Then the results will be compared in two intervention and control groups.Also, after conducting the research in order to comply with the ethical points and if the patients wish, all the cases done for the intervention group will be provided to the patients of the control group in the form of a CD. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Beheshte Tabarsi
The end of Shahid Sattari highway, Tehran
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 4355 btabarsi@iautmu.ac.ir Faculty of Nursing and Midwifery, Azad University of Medical Sciences, Tehran scientific Beheshte Tabarsi
The end of Shahid Sattari highway, Tehran
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 4355 btabarsi@iautmu.ac.ir Faculty of Nursing and Midwifery, Azad University of Medical Sciences, Tehran Iran (Islamic Republic of) People who have HbA1C below 9 (under control of disease complications). Fasting blood sugar should be above 126 and blood sugar two hours after eating should be above 200. Symptoms of leg tingling, constant burning pain, and at the same time constant numbness, and the diagnosis of neuropathy has been given by the attending physician. Have the ability to do foot exercises. no limit no limit Both Unwillingness to continue cooperation. Unfavorable clinical condition of the patient (such as hypoglycemia during exercise that leads to hospitalization of the patient). E00–E90 Endocrine, nutritional and metabolic diseases Behavior Prevention Intervention group: In the intervention group, after selecting the qualified samples and explaining about the research stages, the required concepts and the benefits of leg exercises and how to perform them, the patient's consent is obtained, and then after obtaining a written consent, in the same session, the personal information form and the questionnaire A summary of the pain intensity will be provided to the patient and after going through the above steps, for 12 consecutive weeks and three days a week between 8:00 and 13:00, one training set with 8-10 repetitions per hour individually for each person, in the bed. The patient performs leg exercises in the presence of the researcher, which will take 5-10 minutes. At home, these exercises should be performed 2-3 times a day, 10 repetitions each time, and the number of times will gradually increase, and the patients will be monitored and guided by phone calls at least once a week.Before and after performing leg exercises (before the intervention and then 12 weeks later), the patient's diabetes indicators (glycosylated hemoglobin, fasting blood sugar, blood sugar 2 hours after a meal and body mass index) are measured and recorded. Also, before and after the completion of 12 weeks, the patient's pain level is measured by a questionnaire. Control group: In the control group, the patient's consent will be obtained after the necessary explanations about the research steps. Then, in the same meeting, the personal information form and the brief pain intensity questionnaire form will be completed by the patient. Patients in the control group will receive routine blood sugar control training. In the twelfth week of the visit, the pain assessment form will be provided to them again for completion. The diabetes indicators of the control group patients will be measured and recorded in the same time intervals and exactly at the same time of the day and night (similar to the intervention group), pain and disease symptoms for 12 weeks as the first appointment (first session) and after 12 weeks. Then the results will be compared in two intervention and control groups.Also, after conducting the research in order to comply with the ethical points and if the patients wish, all the cases done for the intervention group will be provided to the patients of the control group in the form of a CD. Diabetic neuropathy pain. Timepoint: Before and after the intervention of foot exercises. Method of measurement: Brief standardized pain intensity questionnaire. Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran Approved 2023-04-26 کمیته اخلاق دانشکده پزشکی دانشگاه علوم پزشکی آزاد اسلامی تهران تهران، خیابان شریعتی، خیابان خاقانی Tehran Tehran Iran (Islamic Republic of)