Whole Body Vibration Therapy in Individuals With Type 2 Diabetes

NCT ID: NCT07002125

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Whole Body Vibration Muscle Oxygenation Aerobic Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The study is planned as a triple-blind, randomized controlled trial. Patients will not be informed about their group. The assessment will be followed by 1 physiotherapist, and the exercise program will be followed by 2 physiotherapists (the physiotherapist performing the assessment is not included). Study groups will be coded before statistical analysis, and the meaning of the codes will not be told to the statistician.

Study Groups

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Aerobic Exercise

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

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Whole Body Vibration

Intervention Type 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

Intervention Type 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.

Interventions

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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)

Intervention Type 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 exercise sessions consist of warm-up, main program and cool-down phases.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role collaborator

Ankara Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Selcan Suicmez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Ankara, Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Selcan Suicmez, Research Asst.

Role: CONTACT

+90 312 444 20 10 ext. 8823

Zeynep Hazar, Prof. Dr.

Role: CONTACT

+90 312 216 26 21

Facility Contacts

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Zeynep Hazar, Prof. Dr.

Role: primary

+90 312 216 26 21

Other Identifiers

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GaziU-FTR-SS-02

Identifier Type: -

Identifier Source: org_study_id

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