Clinical trial NCT05058807: Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy .
Official title: Effects of Whole Body Vibration on Balance, Strength, Glycosylated Hemoglobin Levels in Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to conduct a randomized controlled trail to compare and analyze the effects of both whole body vibrator (WBV) and Tai Chi program on static and dynamic postural balance variables of the diabetic population. The purpose of the study is to determine that whether whole body vibrator is more evident for promoting functional independency and improving balance in diabetic neuropathy. Hence distinguishing choices to prevent fall and advancing functional independency by using the appropriate intervention without using extreme loads.

Detailed description: Diabetes Mellitus (DM) is defined as a state of hyperglycemia, in either fasting or postprandial states. DM is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both . Type 2 diabetes mellitus (T2DM) is one of these diseases and it is characterized by insulin resistance . The International Diabetes Federation (IDF) estimates that the global prevalence of diabetes mellitus is 366 million in 2011 and expects an increase to 552 million in 2030. In this sense, the increase in the DM prevalence, especially in T2D, has become one of the major problems in modern society \[5\]. In this regard, this chronic disease is connected with the increase of obesity prevalence \[6\] and the high levels of physical inactivity \[5\] in people with T2DM.

Peripheral neuropathy is one of the most common complications and consequences of chronic hyperglycemia . This is characterized by a progressive degeneration that primarily affects the small-diameter cutaneous nociceptive fibers. Diabetic patients encounter impaired balance, proprioception loss and decreased ROM. Physical exercise has become a therapy for people with T2DM , improving physical fitness , quality of life, and autonomic modulation ; as well as enhancing metabolic control and insulin sensitivity; and reducing inflammatory markers and neuropathy symptoms . Interestingly, physical activity could also increase the regenerative capacity of cutaneous axons, slowing or preventing neuropathy progression .

Exercises based on whole-body vibration (WBV) training have shown to enhance balance, mobility muscle strength, pain, cardiorespiratory fitness, and bone density, in both healthy and clinical populations. In this regard, a recent systematic review and meta-analysis (with a total of seven studies, involving 279 older adults with T2DM) focused on the effects of WBV determined that this training improved the mobility, balance and aerobic capacity without any known adverse effects. Moreover, WBV could have positive effects on glycemic indices or body composition. Regarding glycemic indices, a previous study showed that acute WBV decreases the glucose level in elderly women with T2DM. However, the effects of WBV intervention on glycosylated hemoglobin (HbA1c) is uncertain. Tai Chi exercise program which is actually a form of proprioceptive and balance training helps in reduction of fall and balance issues and also beneficial for the pain reduction in osteoarthritic patients.

Basic TC exercise is a mind-body exercise composed of a series of refined motions linked together as a rhythmical sequence in which the body is continuously shifting with low center of gravity from one foot to the other. These exercises can help in training of dual task performance as the practitioner's eye focuses on the leading arm and the mind focuses on the breath and movement sequences. It also improves cardiovascular endurance, aerobic capacity and quality of life and reduces stress

Eligibility criteria: Inclusion Criteria:

* Balance : 21-52
* DM type II from past 10 years
* American Diabetes Association (ADA) guideline 2001 or using oral hypoglycemic agent; HbA1C \< 8.5 %
* Taking Medicine and stable patients
* MMSE\>25
* Michigan Diabetic Neuropathy Score (MDNS) between 13 and 29 (mild to moderate neuropathy)

Exclusion Criteria:

* Patients with any musculoskeletal impairment (such as inability to walk independently), vision impairment, vestibular diseases with a diabetes-related etiology, or dementia (Mini-Mental State Examination score \< 24/30)

Primary outcomes:
measure: •Berg Balance Scale
timeFrame: Change from Baseline mobility and balance to 4th week, 8 Weeks
measure: 5 times sit to stand test
timeFrame: Change from Baseline balance to 4th week ,8th Weeks
Secondary outcomes:
measure: Single leg stance test
timeFrame: Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan General Railway Hospital
state: Islamabad
Study officials:
affiliation: Riphah International University Islamabad
name: Misbah ghous, MS
role: PRINCIPAL_INVESTIGATOR
References: