Whole Body Vibration Therapy in Individuals With Type 2 Diabetes

Официальное название

The Effect of Whole Body Vibration Therapy on Muscle Oxygenation in Individuals With Type 2 Diabetes: A Randomized Controlled Trial

Обзор

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: * Does whole body vibration therapy affect peripheral muscle oxygenation? * Does whole body vibration therapy improve vibration sense, functional capacity and balance compared to aerobic exercise? Participants' muscle oxygenation, vibration sensation, functional capacity and balance parameters will be assessed. They will participate in a whole body vibration therapy or aerobic training program.

Вмешательства

• Другое Whole Body Vibration
  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)
• Другое Aerobic Exercise
  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 exerc

Первичные конечные точки

• Muscle Oxygenation [Срок оценки: 8 weeks]

Вторичные конечные точки (5)

• Vibration sense [Срок оценки: 8 weeks]
• The Timed Up & Go Test [Срок оценки: 8 weeks]
• The 6 minute walk test [Срок оценки: 8 weeks]
• The 30-second Chair Stand Test [Срок оценки: 8 weeks]
• Balance [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Volunteering to participate in the research
• Being diagnosed with type 2 diabetes
• 18 years of age or older
• HbA1c level to be 6.5-10%
• Having a clinical history of diabetes between 2-10 years
• Receiving oral hypoglycemic agent treatment
• At least three HbA1c measurements within 12 to 24 months
• Hemoglobin variability score (HVS) <50
• Being able to walk independently
• Mini mental test score ≥ 24
• Vastus lateralis muscle adipose tissue thickness <20mm
• BMI <30 kg/m2

Критерии исключения

• Previous or concurrent psychiatric, neurological, orthopedic or systemic illness
• Use of insulin in treatment
• Diabetic neuropathy
• Foot ulcer
• Participation in any exercise program in the last 6 months
• History of major hypoglycemia in the last 12 months
• Working or have worked in a job with high exposure to mechanical whole body vibrations
• Conditions that may contraindicate whole body vibration (deep vein thrombosis, severe osteoporosis, active cancer, implanted medical devices, etc.)
• Hearing, vision and perception problems that may affect research results

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation — Ankara

Идентификаторы

NCT: NCT07002125 · GaziU-FTR-SS-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗