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RecruitingNCT07002125Updated Aug 26, 2025

Whole Body Vibration Therapy in Individuals With Type 2 Diabetes

An interventional study of Whole Body Vibration and Aerobic Exercise in Type 2 Diabetes, Whole Body Vibration and Muscle Oxygenation, sponsored by Ankara Medipol University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by Ankara Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Type 2 Diabetes
  • Whole Body Vibration
  • Muscle Oxygenation
  • Aerobic Exercise

Keywords

  • Aerobic exercise
  • diapason
  • balance
  • HbA1c
  • type 2 diabetes
  • whole body vibration
  • muscle oxygenation
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Ankara Medipol University is the lead sponsor of 55 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Aerobic Exercise

    The aerobic exercise group (AE) will participate in an ascending aerobic exercise program for 8 weeks, 3 sessions per week.

    Other: Aerobic Exercise

  • Experimental
    Whole Body Vibration

    The whole body vibration group (AE+TVV) will additionally participate in an 8-week incremental aerobic exercise program of 3 sessions per week.

    Other: Whole Body Vibration · Other: Aerobic Exercise

Interventions

  • OtherWhole 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)

  • OtherAerobic 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 exercise sessions consist of warm-up, main program and cool-down phases.

06

What researchers measure

Primary outcomes

  1. Muscle Oxygenation

    Vastus lateralis muscle oxygenation will be evaluated with Near-Infrared Spectroscopy at rest, during and after the 6-Minute Walk Test (6MWT)

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

  5. 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.

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation
    Ankara, Çankaya, Turkey (Türkiye)
    • Zeynep Hazar, Prof. Dr. · Contact · zhazar@gazi.edu.tr · +90 312 216 26 21
    • Selcan Suicmez, Asst. Prof. · Principal investigator
    • Yusuf Kaan Kaya, MSc · Sub investigator
    • Faezeh Shamel, MSc · Sub investigator
    • Zeynep Hazar, Prof. Dr. · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07002125
Lead sponsor
Ankara Medipol University
Collaborators
Gazi University
Responsible party
Selcan Suicmez (Principal Investigator, Ankara Medipol University) — Principal investigator
First posted
Jun 3, 2025
Start date
Aug 1, 2025
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 26, 2025

Study contacts

Selcan Suicmez, Research Asst.
Contact
selcansuicmez@hotmail.com
+90 312 444 20 10 ext. 8823
Zeynep Hazar, Prof. Dr.
Contact
zhazar@gazi.edu.tr
+90 312 216 26 21

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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