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Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy .

R

Riphah International University

Status

Completed

Conditions

Diabetic Neuropathies

Treatments

Other: Whole body vibration group
Other: Tai Chi group

Study type

Interventional

Funder types

Other

Identifiers

NCT05058807
Quratulain

Details and patient eligibility

About

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.

Full 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

Enrollment

40 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Whole body vibration group
Experimental group
Description:
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
Treatment:
Other: Whole body vibration group
TAI CHI Group
Active Comparator group
Description:
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; .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.
Treatment:
Other: Tai Chi group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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