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NCT Number: NCT07002125

Whole Body Vibration Therapy in Individuals With Type 2 Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation

Ankara, Çankaya, Turkey (Türkiye)

Location status: Recruiting

Location contact

Faezeh Shamel, MSc

SUB_INVESTIGATOR

Selcan Suicmez, Asst. Prof.

PRINCIPAL_INVESTIGATOR

Yusuf Kaan Kaya, MSc

SUB_INVESTIGATOR

Zeynep Hazar, Prof. Dr.

CONTACT

[email protected]

+90 312 216 26 21

Zeynep Hazar, Prof. Dr.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

Primary outcomes

  1. Muscle Oxygenation

    Time frame: 8 weeks

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

Secondary outcomes

  1. Vibration sense

    Time frame: 8 weeks

    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.

  2. The Timed Up & Go Test

    Time frame: 8 weeks

    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.

  3. The 6 minute walk test

    Time frame: 8 weeks

    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.

  4. The 30-second Chair Stand Test

    Time frame: 8 weeks

    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.

  5. Balance

    Time frame: 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Selcan Suicmez, Research Asst.

CONTACT

[email protected]

+90 312 444 20 10 ext. 8823

Zeynep Hazar, Prof. Dr.

CONTACT

[email protected]

+90 312 216 26 21

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Collaborators

  • Gazi University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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