NCT03542929

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

April 12, 2018

Last Update Submit

May 18, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • peripheral oxygen saturation (SpO2)

    before and immediately after the 10 minute intervention

  • heart rate (HR)

    before and immediately after the 10 minute intervention

  • Borg's Rating of Perceived Exertion Scale (RPE) or Modified Borg Scale

    before and immediately after the 10 minute intervention

Study Arms (2)

healthy elderly

ACTIVE COMPARATOR

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

Device: whole body vibration

diabetic elderly

EXPERIMENTAL

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

Device: whole body vibration

Interventions

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

diabetic elderlyhealthy elderly

Eligibility Criteria

Age60 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maíra F Pessoa

Recife, Pernambuco, 50.741-530, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A researcher was performed the interventional protocol and a different researcher was made the evaluations
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 31, 2018

Study Start

November 20, 2017

Primary Completion

March 20, 2018

Study Completion

April 30, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations