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IRCT20230502058055N1 IRCT 2023-06-11 Bagheiat-allah University of Medical Sciences Investigating the effect of different intensity of functional training on type 3 diabetes The effect of 3 months of functional training above and below the lactate threshold in retired military veterans with type 3 diabetes 2023-05-21 anticipated 90 Complete https://irct.ir/trial/70064 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: All subjects are randomly divided into 3 groups: high-intensity functional training, low-intensity functional training, and control. In this research design, 2 exercise groups receive independent interventions, while the control group does not receive any intervention and does its daily activities, Randomization description: Subjects were randomly assigned by a research assistant outside the study and in blocks of 4 and using sealed envelopes in one of the functional training group with an intensity higher than the lactate threshold, functional training with Intensity below the lactate threshold and control group. Randomization will be performed using Randomization.com (http://www.randomization.com). The subjects are completely unaware of the grouping and the exercises and counseling sessions will be held on completely separate days, Blinding description: All subjects will be completely blinded to the grouping. For this purpose, exercises and counseling sessions related to each group will be held on completely separate days. Clinical caregivers (trainers) who are separate from the research investigators will be blinded to the grouping. The analysis of the research data will be done by a biostatistician who is not aware of the details of the intervention protocol. Also, in presenting the data to the statistician, it will be avoided to include the names of the subjects and the names of the groups, and the names and groups will be presented in coded form. N/A Type 3 Diabetes. Intervention 1: Intervention group: First: high-intensity functional exercises. Subjects of the functional group with an intensity higher than the lactate threshold (75-85% of the reserve heart rate, equivalent to 80-85% of the maximum oxygen consumption, equivalent to 120-125% of the lactate threshold) first under a A 1-week training course (five sessions per week) will be arranged to familiarize them with the details of the exercises, the gym environment and the equipment. After learning the necessary training for a period of 3 months (5 sessions per week), they will continue functional exercises under the supervision of trainers. Each session of high-intensity performance training will consist of 20-25 minutes of activity, which will include 1- endurance exercises, 2- upper and lower body strength, 3- balance exercises and maintaining posture, 5- hip control exercises and mid-body stability. . The ratio of rest time to activity in this group will be 1:1. 5 minutes of warming up before each session and 5 minutes of cooling down at the end of each session will be considered. The heart rate will be monitored by a polar heart rate monitor to control the training intensity during the training program. Also, lactate levels will be evaluated after the end of each session to determine the intensity level of sports activity. Intervention 2: Intervention group: Second: functional exercises with low intensity. Subjects of the functional group with an intensity lower than the lactate threshold (35-45% of the reserve heart rate, equivalent to 50-60% of the maximum oxygen consumption, equivalent to 70-75% of the lactate threshold) first underwent a 1-week training course (five sessions per week ) will be placed to get to know the details of functional exercises, gym environment and equipment. After learning the necessary training for a period of 3 months (5 sessions per week), they will continue the functional exercises under the supervision of the trainers. Low-intensity functional exercises will be similar to the high-intensity training group, with the difference that the number of repetitions of each movement will be less, but the rest time will be longer. The ratio of rest time to activity in this group is 3:1. Therefore, the approximate time of each session will be between 35-40 minutes. 5 minutes of warming up before each session and 5 minutes of cooling down at the end of each session will be considered. The heart rate will be monitored by a polar heart rate monitor to control the training intensity during the training program. Also, lactate levels will be evaluated after the end of each session to determine the intensity level of sports activity. Intervention 3: Control group: no intervention. The control group will not exercise during the intervention period and will do their usual daily activities. In the weekly meetings, the researchers will evaluate the status of the weekly activities of the control group in the form of questions and answers. Yes - There is a plan to make this available What will be shared: Considering that the main goal of the current research is clinical rehabilitation for the elderly who have cognitive, metabolic and movement disorders. Therefore, sharing the results, data and protocol of the current research can be used for different groups. The results and information obtained from this rehabilitation protocol can initially be used for the health system to deal with the prevalence of old age in the near future in the country. Also, organizations and institutions related to the elderly, including welfare, nursing homes and other areas related to the elderly can use the results and protocol of this research. Therefore, the researchers of this research are responsible for providing the non-identifiable research data, research protocol, statistical information and clinical report to the aforementioned organizations and institutions. When: Access to the data starts immediately after the end of the intervention To whom: All scientific and academic researchers, organizations or institutions active in the field of rehabilitation Conditions: Any use under the title of plagiarism without mentioning the names of the researchers and sponsoring organization is not allowed. Where to obtain: Applicants can apply through the following email to receive documents. majid.mardaniyan@gmail.com How to obtain: After registering the request, the researchers of this research will obtain the approval of the university and the research vice-chancellor and send the documents. Comments:
public Majid Mardaniyan Ghahfarrokhi
Rahbar Boulevard, Shahrekord University
Shahrekord Iran (Islamic Republic of) 8831944793 +98 38 3242 5475 majid.mardaniyan@gmail.com Shahrekord University scientific Majid Mardaniyan Ghahfarrokhi
Rahbar Boulevard, Shahrekord University
Shahrekord Iran (Islamic Republic of) 8831944793 +98 38 3242 5475 majid.mardaniyan@gmail.com Shahrekord university Iran (Islamic Republic of) Age ≥ 60 years Diagnosis of type 2 diabetes Suffering from cognitive impairment based on MMSE score less than 20 60 years 80 years Both Diabetic foot ulcer Participating in regular sports programs or special drug and sports interventions Smoking and drinking alcohol Cancer and performing surgery E12.4 Malnutrition-related diabetes mellitus with neurological complications Rehabilitation Rehabilitation Rehabilitation Intervention group: First: high-intensity functional exercises. Subjects of the functional group with an intensity higher than the lactate threshold (75-85% of the reserve heart rate, equivalent to 80-85% of the maximum oxygen consumption, equivalent to 120-125% of the lactate threshold) first under a A 1-week training course (five sessions per week) will be arranged to familiarize them with the details of the exercises, the gym environment and the equipment. After learning the necessary training for a period of 3 months (5 sessions per week), they will continue functional exercises under the supervision of trainers. Each session of high-intensity performance training will consist of 20-25 minutes of activity, which will include 1- endurance exercises, 2- upper and lower body strength, 3- balance exercises and maintaining posture, 5- hip control exercises and mid-body stability. . The ratio of rest time to activity in this group will be 1:1. 5 minutes of warming up before each session and 5 minutes of cooling down at the end of each session will be considered. The heart rate will be monitored by a polar heart rate monitor to control the training intensity during the training program. Also, lactate levels will be evaluated after the end of each session to determine the intensity level of sports activity. Intervention group: Second: functional exercises with low intensity. Subjects of the functional group with an intensity lower than the lactate threshold (35-45% of the reserve heart rate, equivalent to 50-60% of the maximum oxygen consumption, equivalent to 70-75% of the lactate threshold) first underwent a 1-week training course (five sessions per week ) will be placed to get to know the details of functional exercises, gym environment and equipment. After learning the necessary training for a period of 3 months (5 sessions per week), they will continue the functional exercises under the supervision of the trainers. Low-intensity functional exercises will be similar to the high-intensity training group, with the difference that the number of repetitions of each movement will be less, but the rest time will be longer. The ratio of rest time to activity in this group is 3:1. Therefore, the approximate time of each session will be between 35-40 minutes. 5 minutes of warming up before each session and 5 minutes of cooling down at the end of each session will be considered. The heart rate will be monitored by a polar heart rate monitor to control the training intensity during the training program. Also, lactate levels will be evaluated after the end of each session to determine the intensity level of sports activity. Control group: no intervention. The control group will not exercise during the intervention period and will do their usual daily activities. In the weekly meetings, the researchers will evaluate the status of the weekly activities of the control group in the form of questions and answers. Processing speed. Processing speed score in the SDMT questionnaire. Timepoint: The evaluation will be done in the pre-test (before the start of the intervention) and the post-test (after the end of the intervention). Method of measurement: In order to evaluate the processing speed in the present research, the SDMT test is used to check the processing speed. The SDMT test consists of placing the number associated with a set of symbols in the 90 cells of a table, and the subject has 90 seconds to do this. The final score obtained from this test is considered as the processing speed score. Memory. Memory score in BVMT test. Timepoint: The evaluation will be done in the pre-test (before the start of the intervention) and the post-test (after the end of the intervention). Method of measurement: The BVMT test is related to visual memory, for this purpose, the subject must remember six geometric shapes on a white paper in a 10-second time and draw the shapes 3 times with 25-minute intervals. Putting each shape in its place and with the correct shape has 1 point respectively and the total of the test in each stage is 12 points. The average score of the 3 stages is considered as the memory score. Learning Learning score in CVLT test. Timepoint: The evaluation will be done in the pre-test (before the start of the intervention) and the post-test (after the end of the intervention). Method of measurement: The CVLT test is related to learning 16 words that are read by the test taker, and the test taker must try to write the words he has memorized five times with five minute intervals. Words generally consist of 4 groups of 4 words. The number of correct words recalled in five recall repetitions is considered as the subject's learning score. Attention. attention score in the Stroop test. Timepoint: The evaluation will be done in the pre-test (before the start of the intervention) and the post-test (after the end of the intervention). Method of measurement: The Stroop test requires subjects to view a list of words printed in a different color than the meaning of the word. Participants are required to name the font or ink color of the word as best they can, not the word itself. For example, when presented with the word "green" written in red ink, the person must choose red. It is much easier to name a word whose spelling and ink color are the same, as opposed to when the ink color and the word itself are different. This degree of difficulty is what we call the Stroop effect. Stroop test score will be considered as attention score. Anthropometric, metabolic and physical performance indicators are the secondary variables of the present study. Anthropometric variables such as height, weight, body mass index and fat percentage. Metabolic variables including fasting blood sugar, insulin, glycated hemoglobin, lipid profile and blood lactate. Physical performance variables include. Aerobic endurance, upper and lower body strength, balance, speed, reaction speed and walking ability. Timepoint: pre-test (before the intervention) and post-test (after the intervention). Method of measurement: Height using a wall-mounted scale, weight using a digital scale, body mass index using the body mass index formula, fat percentage using a body composition analysis device will be measured as anthropometric indicators. Blood samples will be taken before and after 3 months of intervention to measure serum glucose, serum insulin, insulin resistance index, glycosylated hemoglobin, lipid profile and blood lactate. In order to measure the ability to walk from a 6-minute walk test, upper body and lower body strength from handgrip tests and standing up and sitting 5 times, balance using static and dynamic balance tests, speed using a 10 meter test. Walking, reaction speed will be measured using long-time intensity and walking tests and six-step walking test. Bagheiat-allah University of Medical Sciences Approved 2023-02-05 Ethics Committee of Baqiyatullah University of Medical Sciences Vanak Square, Mollasadra St., South Sheikh Bahai St Tehran Tehran Iran (Islamic Republic of)