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Recruiting NCT07002125

Whole Body Vibration Therapy in Individuals With Type 2 Diabetes

No phase Interventional Type 2 Diabetes Whole Body Vibration Muscle Oxygenation Aerobic Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole Body Vibration, Aerobic Exercise.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Whole Body Vibration, Muscle Oxygenation, Aerobic Exercise. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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)
  • Other 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

Primary outcome measures

  • Muscle Oxygenation [Time frame: 8 weeks]
Secondary outcome measures (5)
  • Vibration sense [Time frame: 8 weeks]
  • The Timed Up & Go Test [Time frame: 8 weeks]
  • The 6 minute walk test [Time frame: 8 weeks]
  • The 30-second Chair Stand Test [Time frame: 8 weeks]
  • Balance [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation — Ankara

Identifiers

NCT: NCT07002125 · GaziU-FTR-SS-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗