Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients

NCT05083767 | Completed

• 1 other identifier: AmeenMDC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Worldwide, the non-communicable diseases are increasing at an alarming rate in which the cardiovascular diseases and Diabetes Mellitus (DM) are predominantly common in lower middle income countries. According to Center of Disease Control and Prevention, Diabetes Mellitus (DM) is the 7th leading cause of mortality in United States that may leads to visual deficits, limb amputations, and organ failure. The prevalence of diabetes in the last few decades has increased along with obesity. According to World Health Organization (WHO) the world wide prevalence of DM has increased up to 422 million people and out of this majority lived in the low-and middle income countries. Almost 1.6 million of death is directly attributed to diabetes. According to International Diabetic Foundation, by the end of 2040, DM will affect up to 642 million of the world population. In Pakistan, WHO reported that 12.9 million patients (10% of the population) have diabetes, 9.4 million patients have diagnosed diabetes, and 3.5 million have not been diagnosed. On the contrary, 38 million people have prediabetes (20.5% women and 15.9% men). Another research has shown that Pakistan is ranked on 7th out of 10 countries with Type II diabetes and will be 4th by 2030. Moreover, about 120,000 people in Pakistan have been reported to die each year as the result of type II diabetes and relative complicated diseases. The keystone of diabetes management includes pharmacological management and changes in the lifestyle that includes physical activity and diet. Regular exercises not only improve the cardiovascular fitness but also help in improving the regulation of blood glucose there by enhance insulin signaling, improved vascular function and blood lipids, as well as reduced low-grade inflammation, and weight loss. Researchers suggested that physical activity can boost insulin sensitivity for patients with type II diabetes and help to reduce high blood glucose levels. During exercise, the intake of oxygen can increase up to 20 times and is greatly increased in working muscles. However, receptivity to perform exercises among general population is poor; mainly due to substantial commitment of time associated in performing these exercises. As a passive interference, therefore, Whole-body vibration (WBV) was introduced. Vibration training elevates, energy utilization and increases the blood flow of periphery. Hence the current study was focused on examining the effects of WBV on HbA1c and Fasting Blood Sugar (FBS) in type II diabetic patients.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• HbA1c

  Baseline

• HbA1c

  12 weeks

• Fasting Blood Sugar

  Baseline

• Fasting Blood Sugar

  12 weeks

Study Arms (2)

Whole Body Vibration

EXPERIMENTAL

Other: Experimental

Control Group

PLACEBO COMPARATOR

Other: Control

Interventions

Experimental OTHER

The study protocol of WBV includes twelve weeks of whole-body vibration training provided to the Type 2 diabetic patients. It was recommended to all participants that they follow their regular diet and medication during the training. Two sets of six 1-minute vibration squats were designed with 20 seconds of rest, 3 times weekly for a duration 12 weeks (total workout time 36 minutes a week), using a vertical vibration machine. The six static positions consisted of (a) a deep squat position (knee angle 900) (b) an elevated squat position (knee angle 1250) (c) an elevated squat position (with elevated heels) (d) a slight knee flexion1 (hand straps with shoulder bending) (e) a slight knee flexion (hand straps with shoulder abduction) and (f) a slight knee flexion 3 (hand straps with elbow flexion). The training load steadily increased from the initial vibration of 30 Hz and the platform amplitude was raised from 2 mm at week 1 to 40 Hz and from 4 mm at week 5 to the completion of training.

Whole Body Vibration

Control OTHER

The control group was advised to their normal physical activity level, diet, and medication.

Control Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients
• Age between 40-70 years

You may not qualify if:

• Diagnosed neurological and cardiovascular condition
• Untreated orthostatic hypotension
• unwilling to participate

Sponsors & Collaborators

• Ameen Medical and Dental Center: lead

Study Sites (1)

Ameen Medical and Dental Center

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sobia Hasan, MS

  Ameen Medical and Dental Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: April 3, 2019
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)