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

NCT ID: NCT06033508

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-11-01

Brief Summary

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.

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.

Conditions

Type 2 Diabetes; Diabetic Peripheral Neuropathy; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

T2DM with neuropathy + WBV

Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration

Group Type: ACTIVE_COMPARATOR

exercise with whole body vibration device

Intervention Type: OTHER

exercise with whole body vibration device

T2DM without neuropathy + WBV

Patients with type 2 Diabetes mellitus without neuropathy who will be trained by whole body vibration

Group Type: ACTIVE_COMPARATOR

exercise with whole body vibration device

Intervention Type: OTHER

exercise with whole body vibration device

T2DM without neuropathy + land exercise

Patients with type 2 Diabetes mellitus without neuropathy who will be trained on land

Group Type: PLACEBO_COMPARATOR

placebo exercise

Intervention Type: OTHER

exercise without vibration on land

Interventions

exercise with whole body vibration device

exercise with whole body vibration device

Intervention Type: OTHER

placebo exercise

exercise without vibration on land

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

GULIN FINDIKOGLU

Assoc Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GULIN FINDIKOGLU, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University, Medical Faculty, PMR Department

Locations

Pamukkale University

Denizli, Denizli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-60116787-020-338517

Identifier Type: -

Identifier Source: org_study_id