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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03542929
Other study ID # Whole body vibration glucose
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2017
Est. completion date April 30, 2018

Study information

Verified date May 2018
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date April 30, 2018
Est. primary completion date March 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 74 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
whole body vibration
whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly

Locations

Country Name City State
Brazil Maíra F Pessoa Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Maíra F Pessoa

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in glucose levels 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
Primary Changes in lactate levels 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 peripheral oxygen saturation (SpO2) measured with a digital oximeter Onyx (Nonim, model 9500, USA) before and immediately after the 10 minute intervention
Secondary heart rate (HR) measured with a digital oximeter Onyx (Nonim, model 9500, USA) before and immediately after the 10 minute intervention
Secondary Borg's Rating of Perceived Exertion Scale (RPE) or Modified Borg Scale visual scale that measure the perceived exertion in muscle or dyspnoea, measuring values between 0 at 10 before and immediately after the 10 minute intervention
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