- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05083767
Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients
Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Ameen Medical and Dental Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetic patients
- Age between 40-70 years
Exclusion Criteria:
- Diagnosed neurological and cardiovascular condition
- Untreated orthostatic hypotension
- unwilling to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control Group
|
The control group was advised to their normal physical activity level, diet, and medication.
|
EXPERIMENTAL: Whole Body Vibration
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: 12 weeks
|
12 weeks
|
HbA1c
Time Frame: Baseline
|
Baseline
|
Fasting Blood Sugar
Time Frame: Baseline
|
Baseline
|
Fasting Blood Sugar
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sobia Hasan, MS, Ameen Medical and Dental Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AmeenMDC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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