CClinicalTrials.gg
CompletedNCT03542929Updated May 31, 2018

Acute Whole Body Vibration Change the Glycemic and Lactate Levels

An interventional study of whole body vibration in Diabetes, sponsored by Maíra F Pessoa. Completed at 1 site in Brazil. Open to female participants aged 60 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Maíra F Pessoa · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
60 Years to 74 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Maíra F Pessoa is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 74 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Active comparator
    healthy elderly

    healthy elderly were use the Whole body vibration intervention during 10 minutes

    Device: whole body vibration

  • Experimental
    diabetic elderly

    diabetic elderly were use the Whole body vibration intervention during 10 minutes

    Device: whole body vibration

Interventions

  • Devicewhole body vibration

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: before and immediately after the 10 minute intervention

  2. 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).

    Time frame: before and immediately after the 10 minute intervention

Secondary outcomes

  1. peripheral oxygen saturation (SpO2)

    measured with a digital oximeter Onyx (Nonim, model 9500, USA)

    Time frame: before and immediately after the 10 minute intervention

  2. heart rate (HR)

    measured with a digital oximeter Onyx (Nonim, model 9500, USA)

    Time frame: before and immediately after the 10 minute intervention

  3. 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

    Time frame: before and immediately after the 10 minute intervention

07

Study locations

1 site
  • Maíra F Pessoa
    Recife, Pernambuco 50.741-530, Brazil
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03542929
Lead sponsor
Maíra F Pessoa
Responsible party
Maíra F Pessoa (Clinical Professor, Universidade Federal de Pernambuco) — Sponsor-investigator
First posted
May 31, 2018
Start date
Nov 20, 2017
Primary completion
Mar 20, 2018
Completion
Apr 30, 2018
Last update
May 31, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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