Whole Body Vibration Therapy in Individuals With Type 2 Diabetes

NCT07002125 | Recruiting

• 1 other identifier: GaziU-FTR-SS-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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)

  8 weeks

Secondary Outcomes (5)

• Vibration sense

  8 weeks

• The Timed Up & Go Test

  8 weeks

• The 6 minute walk test

  8 weeks

• The 30-second Chair Stand Test

  8 weeks

• Balance

  8 weeks

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

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

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.

Other: Whole Body Vibration; Other: Aerobic Exercise

Interventions

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)

Whole Body Vibration

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.

Aerobic Exercise; Whole Body Vibration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the research
• Being diagnosed with type 2 diabetes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Medipol University: lead
• Gazi University: collaborator

Study Sites (1)

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

Ankara, Çankaya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Selcan Suicmez, Research Asst.

CONTACT

+90 312 444 20 10; selcansuicmez@hotmail.com

Zeynep Hazar, Prof. Dr.

CONTACT

+90 312 216 26 21; zhazar@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: June 3, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)