Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients with and Without Polyneuropathy

February 3, 2025 updated by: GULIN FINDIKOGLU, Pamukkale University
The aim of this study is to show how whole body vibration training practiced for 12 weeks affects the levels of inflammatory biomarkers such as C reactive protein (CRP) and, interleukin-6 (IL-6), in Type 2 diabetic patients (T2DM) with and without peripheral neuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volunteers with type 2 diabetes mellitus with and without peripheric neuropathy will be evaluated in terms of any contra-indication that will restrain them from making exercise with whole body vibration device. 60 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 20 participants. 1st group will include type 2 diabetic patients with peripheric neuropathy and 2nd and 3rd groups will include type 2 diabetic patients without neuropathy. Patients in group 1 and 2 will make static isometric exercises on vibration platform whereas patients in group 3 will make the same exercises on land in the hospital setting. Participants will be requested to complete 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with physical measures such as waist and hip circumference, 6-minute walk test, body composition measured by bioimpedance, muscle thickness, and blood tests to measure inflammatory biomarkers.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 21600
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants must stand and walk o without using an assistive device.
  2. Participants must have a weight of less than 120 kg.

Exclusion Criteria:

  1. T2DM patients with advanced cardiovascular, renal, hepatic disease
  2. T2DM patients with diabetic retinopathy or nephropathy
  3. T2DM patients with untreated hypertension, rhythm disorders, and those who have undergone bypass surgery
  4. T2DM patients with ischemic changes in the resting ECG
  5. T2DM patients with untreated hypoglycemia or orthostatic hypotension
  6. T2DM patients who are unable to walk independently, or use of canes, crutches or wheelchairs
  7. T2DM patients who have open ulcers or wounds on load-bearing surfaces
  8. T2DM patients with inflammatory rheumatic diseases such as rheumatoid arthritis
  9. T2DM patients with active infectious disease
  10. T2DM patients with high risk of thrombosis, those with deep vein thrombosis
  11. T2DM patients who carry a pacemaker, prosthesis, intrauterine device or metal implant,
  12. T2DM patients with a history of cancer
  13. T2DM patients with severe migraine, epilepsy, stroke or other neurological disorders, those who have undergone brain surgery
  14. T2DM patients with non-diabetic neuropathy due to reasons such as HIV, AIDS, alcohol, uremia
  15. T2DM patients with cognitive impairment
  16. T2DM patients who are on psychotropic or neurotoxic therapy
  17. T2DM patients with advanced balance problems
  18. T2DM patients who are pregnant or breastfeeding mothers
  19. T2DM patients who are organ transplant recipients
  20. T2DM patients with hernia
  21. T2DM patients with kidney or bladder stones
  22. T2DM patients who are exposed to mechanical vibration due to their job

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: T2DM with neuropathy + WBV
Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration
Other: exercise with whole body vibration device
exercise with whole body vibration device
Active Comparator: T2DM without neuropathy + WBV
Patients with type 2 Diabetes mellitus without neuropathy who will be trained by whole body vibration
Other: exercise with whole body vibration device
exercise with whole body vibration device
Placebo Comparator: T2DM without neuropathy + land exercise
Patients with type 2 Diabetes mellitus without neuropathy who will be trained on land
Other: placebo exercise
exercise without vibration on land

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 min walk test
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: GULIN FINDIKOGLU, Assoc Prof, Pamukkale University, Medical Faculty, PMR Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-60116787-020-338517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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