Clinical trial NCT05083767: Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients
Official title: Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Ameen Medical and Dental Center
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: A double-blinded randomized controlled trial was conducted among type-II diabetic patients; aged 40-70 years recruited between April 2019 to May 2020 using simple random sampling technique's envelope method from a primary care center of Karachi. All the participants were initially screened by two certified diabetes educators and certified health fitness programmers. Participants were given informed consent prior to intervention, their voluntary participation and understanding of the protocol was ensured prior to the commencement of protocol.

Participants who met the inclusion criteria were assigned by computer-generated number into two groups A and B (n=15) in each group. Group A was provided with Whole Body Vibration (WBV) for twelve weeks whereas Group B (control group) was instructed to continue their medications and dietary plan. The outcome measure of the study was FBS and HbA1c.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: HbA1c
timeFrame: Baseline
measure: HbA1c
timeFrame: 12 weeks
measure: Fasting Blood Sugar
timeFrame: Baseline
measure: Fasting Blood Sugar
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ameen Medical and Dental Center
state: Sindh
Study officials:
affiliation: Ameen Medical and Dental Center
name: Sobia Hasan, MS
role: PRINCIPAL_INVESTIGATOR
References: