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IRCT20220726055557N1 IRCT 2022-08-07 Islamic Azad University Investigating the effect of vision exercises and balance exercises The Effect of Vision and balance training ON vision perception, motor function and quality of life in diabetic patients 2022-08-20 anticipated 85 Complete https://irct.ir/trial/64956 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients will be randomly assigned to four groups vision exercises, balance exercises, combined exercises, and control groups with a 1:1 allocation ratio. Block randomization method will be used for random allocation of patients. The randomized patient allocation sequence will be created by the random allocation software, the name of the software is Random Allocation Software, we put the data in the software, and then the software itself does it, Blinding description: After allocation, it was not possible to keep the trainer blind to each participant's allocated intervention. But the evaluator remained blind. N/A Type 2 diabetes. Intervention 1: The first intervention group: the group of balance exercises, which includes three sessions per week and one hour each session for balance exercises, which includes functional strength and resistance exercises and some yoga movements. (subject to the principle of overload). Intervention 2: Intervention group: eye exercises that are held on the 8th of every week for three sessions and each session is one hour. The exercises include eye saccade exercises and tracking exercises of the week. (subject to the principle of overload). Intervention 3: Intervention group:The third intervention group, where balance and eye combined exercises will be held in eight weeks, three sessions per week, and each session will be held for one hour. Half of the class will be on balance exercises, which are the exercises of the first intervention group, and half of the class will be on eye exercises, which are in the second intervention class. (subject to the principle of overload). Intervention 4: Control group: In this group, only people will be helped for the pre-test and post-test, the pre-tests will be taken from the control group in the first session, just like the three intervention groups, and after eight weeks, the post-test will be taken from the group, just like the three intervention groups. Yes - There is a plan to make this available What will be shared: The provided files are in the form of a complete Excel file, in which the history of the patients, fasting blood sugar and hemoglobin A1C levels, underlying diseases and surgery, and the extent of the disease are described. The site consent form will be designed and provided to each participant After completing the intervention steps, a full report of the clinical interventions will be prepared and will be accessible in the file as a document When: The Excel file of the participants' profile can be accessed after it is completed and before the start of the intervention An informed consent form will be available at the first session after the start of the intervention when all participants have signed it The file of clinical interventions will be available in the last session of the intervention and after the results and approval of the relevant judges and professors and after printing. To whom: People related to this research will have access permission, such as supervisors, advisors, and referees. Apart from the details of the participants, other researchers working in academic and scientific institutions will have the necessary access Conditions: Access to all parts of this study will be granted solely for treatment and to supplement and improve research Where to obtain: To access this information, they can go to the email address: khazaelihanieh200@gmail.com And rokhsareh.badami@gmail.com Visit How to obtain: Applicants can access the information after one working week after entering the email address Comments:
public Hanieh Khazaeli
No.26, Rostam Niya Ave, North Montazeri Blvd, Najaf Abad Town
Najaf Abad Iran (Islamic Republic of) 8514913551 +98 31 4251 5080 khazaelihanieh200@gmail.com Islamic Azad University scientific Rokhsare Badami
University Blvd, Arghavanieh Ave, Eastern Jey St, Esfahan Town
Esfahan Iran (Islamic Republic of) 8155139998 0098 31 35354001-9 rokhsareh.badami@khuisf.ac.ir Islamic Azad University Iran (Islamic Republic of) Gender and age of (women with type 2 dibetes 50 to 65 years) The only medicine that can be taken is metformin tablets Voluntary participation and informed consent Absence of kidney, cardiovascular, orthopedic and neurological diseases Not using walkers, canes and other aids Balance disorder Literate to read and write to answer the questionnaire and written consent Good visual acuity Having type 2 diabetes that has been diagnosed for more than 12 months Not having regular sports activities other than practical exercises by the researcher during the course 50 years 65 years Female Drug use other than metformin tablets Simultaneous participation in orthopedic treatment programs (physiotherapy, neuropathy or surgery) and exercise in line with studying during the course. Age less than 50 years and more than 65 years Patients less than one year old who have been diagnosed with type 2 diabetes E11 دیابت نوع 2 و چشم پزشکی Rehabilitation Rehabilitation Rehabilitation N/A The first intervention group: the group of balance exercises, which includes three sessions per week and one hour each session for balance exercises, which includes functional strength and resistance exercises and some yoga movements. (subject to the principle of overload) Intervention group: eye exercises that are held on the 8th of every week for three sessions and each session is one hour. The exercises include eye saccade exercises and tracking exercises of the week. (subject to the principle of overload) Intervention group:The third intervention group, where balance and eye combined exercises will be held in eight weeks, three sessions per week, and each session will be held for one hour. Half of the class will be on balance exercises, which are the exercises of the first intervention group, and half of the class will be on eye exercises, which are in the second intervention class. (subject to the principle of overload) Control group: In this group, only people will be helped for the pre-test and post-test, the pre-tests will be taken from the control group in the first session, just like the three intervention groups, and after eight weeks, the post-test will be taken from the group, just like the three intervention groups. Balance level of people with type 2 diabetes. Timepoint: The first session will be taken at the beginning of the pre-test intervention and the post-test will be taken after eight weeks of intervention. Method of measurement: To measure balance from the Berg Balance Scale and Tinetti Balance Test. The level of visual perception of people with type 2 diabetes. Timepoint: The first session will be taken at the beginning of the pre-test intervention and the post-test will be taken after eight weeks of intervention. Method of measurement: Using the National Eye Institute Visual Functioning Questionnaire 25. Motor Function of people with type 2 diabetes. Timepoint: The first session will be taken at the beginning of the pre-test intervention and the post-test will be taken after eight weeks of intervention. Method of measurement: Using the 6-minute walk test 6Movement Walk Test. Quality of life of people with type 2 diabetes. Timepoint: The first session will be taken at the beginning of the pre-test intervention and the post-test will be taken after eight weeks of intervention. Method of measurement: Using the Quality of Life 36 Question test and the Hospital Anxiety and Depressin Scale questionnaire. Hanieh Khazaeli Approved 2022-07-03 Ethics Committee of Azad University of Khorasgan branch University Blvd, Arghavanieh Ave, Eastern Jey Str, Esfahan Town Esfahan Isfehan Iran (Islamic Republic of)