Type 2 Diabetes, Diabetic Peripheral Neuropathy, Exercise
Conditions
Keywords
Type 2 diabetes mellitus, Diabetic Peripheral Neuropathy, whole body vibration, inflammation
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.
Interventions
OTHERexercise with whole body vibration device
exercise with whole body vibration device
OTHERplacebo exercise
exercise without vibration on land
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 min walk test | 12 weeks |
Countries
Turkey (Türkiye)
Outcome results
None listed