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| Name | Class |
|---|---|
| Gazi University | OTHER |
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The aim of this interventional study is to investigate the effect of whole body vibration therapy on muscle oxygenation, vibration sensation, functional capacity and balance in individuals with Type 2 diabetes.
The main questions aimed to be answered are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise | Experimental | The aerobic exercise group (AE) will participate in an ascending aerobic exercise program for 8 weeks, 3 sessions per week. |
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| Whole Body Vibration | Experimental | The whole body vibration group (AE+TVV) will additionally participate in an 8-week incremental aerobic exercise program of 3 sessions per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Body Vibration | Other | Each exercise session will be performed with a frequency of 30 Hz and an amplitude of 2 mm. Participants are in a 110° squat position on the platform (the degree will be adjusted using a goniometer). Participants will exercise for 16 minutes from week one to week three, 20 minutes from week four to week six and 24 minutes from week seven to week eight, respectively (8 iterations and 1 minute of vibration with 1 minute interval between each iteration) |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Oxygenation | Vastus lateralis muscle oxygenation will be evaluated with Near-Infrared Spectroscopy at rest, during and after the 6-Minute Walk Test (6MWT) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vibration sense | The sense of vibration will be assessed with a 128 Hz diapason. The lower end of the device will be brought into contact with the plantar surface of the first metatarsal bone, the medial malleolus, and the medial tuberosity of the tuberositas tibia in both lower extremities of the individual. The moment the diapozone touches the tested areas will be considered as the zero-second (0th second, start), and the test will be terminated when the individual perceives that the vibration disappears completely and the time will be recorded in seconds. Three trials will be performed on the areas in both lower extremities, and the average will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selcan Suicmez, Research Asst. | Contact | +90 312 444 20 10 | 8823 | selcansuicmez@hotmail.com |
| Zeynep Hazar, Prof. Dr. | Contact | +90 312 216 26 21 | zhazar@gazi.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation | Recruiting | Ankara | Çankaya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Individuals with Type 2 diabetes who agreed to participate in the study will be divided into two groups as aerobic exercise group (AE) and whole body vibration group (AE+WBV).
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The study is planned as a triple-blind, randomized controlled trial. Patients will not be informed about their group. The assessment will be followed by 1 physiotherapist, and the exercise program will be followed by 2 physiotherapists (the physiotherapist performing the assessment is not included). Study groups will be coded before statistical analysis, and the meaning of the codes will not be told to the statistician.
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| Aerobic Exercise | Other | From week one to week three, from week four to week six and from week seven to week eight, the participants will exercise for 30 minutes (5 minutes of running at 60-70% of heart rate and 5 minutes of active rest at 30-45% of maximum heart rate), 42 minutes (7 minutes of running at 60-70% of heart rate and 7 minutes of active rest at 30-45% of maximum heart rate) and 60 minutes (10 minutes of running at 60-70% of heart rate and 10 minutes of active rest at 30-45% of maximum heart rate). The exercise sessions consist of warm-up, main program and cool-down phases. |
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| 8 weeks |
| The Timed Up & Go Test | It is a measurement that evaluates functional mobility, dynamic balance, fall risk and postural stability that can be applied for different purposes in different age and patient groups. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The TUG test measures the time it takes for an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit back down. | 8 weeks |
| The 6 minute walk test | The individual is asked to walk on a certain track for 6 minutes. The test is performed in a closed area, on a flat surface of 30 m in length and under the supervision of the evaluator. After six minutes, the total distance walked is recorded in meters. | 8 weeks |
| The 30-second Chair Stand Test | In a chair with a sitting height of 43.2 cm and a back supported, the patient is asked to sit and stand as quickly as possible. The patient sits in the chair. They cross their hands on their chest. Before the test, 2 attempts are made. The number of sitting down times is noted by keeping a 30-second timer with a stopwatch. Less than 10 sit-ups in 30 seconds indicates lower extremity muscle weakness. | 8 weeks |
| Balance | Balance assessment will be performed with the Biodex Balance System (Biodex Medical Systems Inc., Shirley, NY, USA). The static balance test (eyes open-closed) test, which measures the angular movement of the center of gravity, will be used in the study. | 8 weeks |
| D004700 | Endocrine System Diseases |