- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542929
Acute Whole Body Vibration Change the Glycemic and Lactate Levels
May 18, 2018 updated by: Maíra F Pessoa
Acute Whole Body Vibration Decrease the Glucose Levels in Elderly Diabetic Women
The type II diabetes is characterized by high levels of blood glucose followed by excessive insulin release so that the target cells become less sensitive and develop insulin resistance, maintaining hyperglycemic levels.
The Whole body vibration session may improve the glucose metabolism in diabetic patients by reducing the peripheral blood sugar.
Ten healthy elderly women and eight diabetic elderly women were allocated into two groups, and have made an acute whole body session.
Study Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
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Recife, Pernambuco, Brazil, 50.741-530
- Maíra F Pessoa
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- elderly between 60 to 74 years,
- sedentary according the International Physical Activity Questionnaire (IPAQ- short form)
- For diabetic group, were considered who those medical diagnoses of type II diabetes for at least 02 complete years, who had used only oral hypoglycemic agents of biguanides class (Metformin extended release - XR) in dosage between 500 to 850 mg.
- For healthy elderly group were considered elderly women without self-reported diseases
Exclusion Criteria:
- diabetic volunteers who have ingested the breakfast less than 02 hours or more than 03 hours and those who have taken Metformin less than 02 hours before the intervention.
For all volunteers, the complementary exclusion criteria were:
- the current or past smoking or alcoholic habits;
- the cardiovascular, liver or neuromuscular diseases;
- subjects with prior labyrinthitis or embolic events;
- who have had any surgery in last year;
- volunteers with metallic prosthesis as pacemaker, pins or plates;
- volunteers with advanced osteoporosis;
- which had difficulties during the evaluation or acute protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: healthy elderly
healthy elderly were use the Whole body vibration intervention during 10 minutes
|
whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly
|
|
Experimental: diabetic elderly
diabetic elderly were use the Whole body vibration intervention during 10 minutes
|
whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in glucose levels
Time Frame: before and immediately after the 10 minute intervention
|
A digital puncture with disposable lancets was collected a peripheral blood drop in the specific strip for the home glucose monitoring AccuChek Active® (Roche Diagnostics GmbH, Mannheim, Germany) according to International Organization for Standardization (ISO) recommendations in 2013 (11).
|
before and immediately after the 10 minute intervention
|
|
Changes in lactate levels
Time Frame: before and immediately after the 10 minute intervention
|
Another peripheral blood drop was collected from the same digital puncture with disposable lancets and put in the specific strip for to check the seric blood lactate, which was analyzed by a portable lactimeter Accutrend Plus ® (Roche Accutrend Plus, New York, USA).
|
before and immediately after the 10 minute intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
peripheral oxygen saturation (SpO2)
Time Frame: before and immediately after the 10 minute intervention
|
measured with a digital oximeter Onyx (Nonim, model 9500, USA)
|
before and immediately after the 10 minute intervention
|
|
heart rate (HR)
Time Frame: before and immediately after the 10 minute intervention
|
measured with a digital oximeter Onyx (Nonim, model 9500, USA)
|
before and immediately after the 10 minute intervention
|
|
Borg's Rating of Perceived Exertion Scale (RPE) or Modified Borg Scale
Time Frame: before and immediately after the 10 minute intervention
|
visual scale that measure the perceived exertion in muscle or dyspnoea, measuring values between 0 at 10
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before and immediately after the 10 minute intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2017
Primary Completion (Actual)
March 20, 2018
Study Completion (Actual)
April 30, 2018
Study Registration Dates
First Submitted
April 12, 2018
First Submitted That Met QC Criteria
May 18, 2018
First Posted (Actual)
May 31, 2018
Study Record Updates
Last Update Posted (Actual)
May 31, 2018
Last Update Submitted That Met QC Criteria
May 18, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Whole body vibration glucose
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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