Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Experimental
Control
Sponsored by

About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
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
Sites / Locations
- Ameen Medical and Dental Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Whole Body Vibration
Control Group
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
HbA1c
Fasting Blood Sugar
Fasting Blood Sugar
Secondary Outcome Measures
Full Information
NCT ID
NCT05083767
First Posted
October 6, 2021
Last Updated
October 18, 2021
Sponsor
Ameen Medical and Dental Center
1. Study Identification
Unique Protocol Identification Number
NCT05083767
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
May 22, 2020 (Actual)
Study Completion Date
May 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ameen Medical and Dental Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole Body Vibration
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control group was advised to their normal physical activity level, diet, and medication.
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
Baseline
Title
HbA1c
Time Frame
12 weeks
Title
Fasting Blood Sugar
Time Frame
Baseline
Title
Fasting Blood Sugar
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sobia Hasan, MS
Organizational Affiliation
Ameen Medical and Dental Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ameen Medical and Dental Center
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients
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