Type 2 DiabetesNCT07002125
Whole Body Vibration Therapy in Individuals With Type 2 Diabetes
A study testing Whole Body Vibration and Aerobic Exercise in people with Type 2 Diabetes and Whole Body Vibration, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Whole Body Vibration, Muscle Oxygenation
- What is being tested?
- Whole Body Vibration and Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation
Ankara, Çankaya
Zeynep Hazar, Prof. Dr., +90 312 216 26 21, zhazar@gazi.edu.tr
Selcan Suicmez, Asst. Prof.
About this study
Official title: The Effect of Whole Body Vibration Therapy on Muscle Oxygenation in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
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.
- Being tested
- Whole Body Vibration, Aerobic Exercise
- Keywords
- Aerobic exercise, diapason, balance, HbA1c, type 2 diabetes, whole body vibration, muscle oxygenation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationOther
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 ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | The aerobic exercise group (AE) will participate in an ascending aerobic exercise program for 8 weeks, 3 sessions per week. Receives: Other: Aerobic Exercise |
| 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. Receives: Other: Whole Body Vibration; Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Oxygenation
Vastus lateralis muscle oxygenation will be evaluated with Near-Infrared Spectroscopy at rest, during and after the 6-Minute Walk Test (6MWT)
Measured: 8 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Aug 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Selcan Suicmez, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002125
- Sponsor's protocol ID
- GaziU-FTR-SS-02
- Status last verified
- Aug 2025
- First submitted
- 17 May 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration Therapy on Muscle Oxygenation in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07002125
- Acronym / sponsor ID
- GaziU-FTR-SS-02
- Keywords
- Aerobic exercise, diapason, balance, HbA1c, type 2 diabetes, whole body vibration, muscle oxygenation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Other: Aerobic ExerciseThe aerobic exercise group (AE) will participate in an ascending aerobic exercise program for 8 weeks, 3 sessions per week. |
| Whole Body Vibration | Experimental | Other: Whole Body Vibration, Other: Aerobic ExerciseThe whole body vibration group (AE+TVV) will additionally participate in an 8-week incremental aerobic exercise program of 3 sessions per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body VibrationEach 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 | Whole Body Vibration |
| Aerobic ExerciseFrom 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. | Other | Aerobic Exercise, Whole Body Vibration |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration and Aerobic Exercise in people with Type 2 Diabetes and Whole Body Vibration, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selcan Suicmez, Research Asst. (+90 312 444 20 10 ext. 8823, selcansuicmez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Oxygenation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.