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

Pamukkale University

Status: Completed

Conditions: Type 2 Diabetes; Exercise; Diabetic Peripheral Neuropathy

Treatments: Other: placebo exercise; Other: exercise with whole body vibration device

Study type: Interventional

Funder types: Other

Identifiers

NCT06033508

E-60116787-020-338517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

T2DM with neuropathy + WBV

Active Comparator group

Description:

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

Treatment:

Other: exercise with whole body vibration device

T2DM without neuropathy + WBV

Active Comparator group

Description:

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

Treatment:

Other: exercise with whole body vibration device

T2DM without neuropathy + land exercise

Placebo Comparator group

Description:

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

Treatment:

Other: placebo exercise