Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy .

Diabetic Neuropathies Clinical Trial

Official title:

Effects of Whole Body Vibration on Balance, Strength, Glycosylated Hemoglobin Levels in Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058807
• Other study ID #: Quratulain
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: December 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Other:
• Whole body vibration group
Experimental Group will receive WBV training and balance exercises under the supervision of a physical therapist by using a vibration platform. Balance exercises include: Double leg stance with eyes open and eyes closed 10 Reps * 3 minutes Tandem walk for 3 minutes Sideways walk for 3 minutes Single leg stance for 1 minute with 5 Reps, with 30 sec rest interval WHOLE BODY VIBRATION: The patient stood on the platform with his/her feet barefoot shoulder width and stared at the front, delivered on a side alternating vibration platform in an intermittent way: five repetitions of 1 min vibration followed by a 1 min rest. The vibration frequency and amplitude were 20 Hz and 3.0 mm respectively. These outcomes will be evaluated at baseline, and after 4 week and at 8th week
• Tai Chi group
Control group will receive Balance exercises include: Double leg stance with eyes open and eyes closed 10 Reps * 3 minutes Tandem walk for 3 minutes Sideways walk for 3 minutes Single leg stance for 1 minute with 5 Reps ,with 30 sec rest interval Yang style Tai chi exercise which consist of 10 positions. 1. Hold the ball ward off 2: Grasping the sparrows tail left; 3.Grasping the sparrows tail Right;; 5.Repulse Monkey; 6. Part wild horse's Mane; 7.Brush knee Twist step; 8.Lift kick left; 9.Lift kick Right; 10.Cross hands with double leg stance 1st and 2nd week will last for 5reps, 3rd and 4th week will last for 10reps,5th and 6th week will last for 15reps,7th and 8th week will last for 20reps, starting with 10 minutes warming- up and ending with 10 minutes cool-down. These outcomes will be evaluated at baseline, and after 4 week and at 8th week

Locations

Country	Name	City	State
Pakistan	Pakistan General Railway Hospital	Rawalpindi	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	•Berg Balance Scale	BBS is a gold standard tool, developed by Berg et al. in 1998 for functional assessment of balance. It has been widely used for older people with balance impairments, stroke, Parkinson's disease, vestibular disorders and in different healthcare settings (7,23). It consists of 14 items to detect static (5 items) and dynamic (9 items) balance. Each item has a score of 0-4 on ordinal scale. Total score is 56, higher the score better is the balance. 0-20 indicates poor balance and predicts high risk of fall, 21-40 indicates acceptable balance and medium fall risk and 41-56 indicates good balance and low fall risk (7, 24). BBS exhibits an excellent reliability; test-retest (ICC) = 0.91) and inter-rater (ICC = 0.97). This scale also has some limitations such as it has a little focus on gait and dynamic balance. Secondly, it has ceiling effect that was reported as 22.5% in community-dwelling older adults	Change from Baseline mobility and balance to 4th week, 8 Weeks
Primary	5 times sit to stand test	To evaluate lower-limb muscle strength, the five-times-sit-to stand (FTSTS) test was used. For this test, the subject was asked to sit in an armless chair (with its back supported against a wall) with arms crossed over his/her chest and then instructed to stand and sit five times as quickly as possible. The same chair was used for all subjects. Subjects performed two timed trials. The instructor commenced the test with "Ready, Set, Go", started a digital stopwatch on "Go," and counted aloud each of the five completed sit to stand cycles. The stopwatch was stopped when the subject returned to the seated position for the fifth time	Change from Baseline balance to 4th week ,8th Weeks
Secondary	Single leg stance test	The Single leg Stance (SLS) Test is used to assess static postural and balance control. Balance assessments (like SLS test) are a valuable clinical tool for monitoring neurological and musculoskeletal status as well as for managing fall risk	Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks