- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03542929
Acute Whole Body Vibration Change the Glycemic and Lactate Levels
18. maj 2018 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pernambuco
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Recife, Pernambuco, Brasilien, 50.741-530
- Maíra F Pessoa
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år til 74 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: healthy elderly
healthy elderly were use the Whole body vibration intervention during 10 minutes
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whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly
|
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Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in glucose levels
Tidsramme: 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).
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before and immediately after the 10 minute intervention
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Changes in lactate levels
Tidsramme: before and immediately after the 10 minute intervention
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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).
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before and immediately after the 10 minute intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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peripheral oxygen saturation (SpO2)
Tidsramme: before and immediately after the 10 minute intervention
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measured with a digital oximeter Onyx (Nonim, model 9500, USA)
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before and immediately after the 10 minute intervention
|
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heart rate (HR)
Tidsramme: before and immediately after the 10 minute intervention
|
measured with a digital oximeter Onyx (Nonim, model 9500, USA)
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before and immediately after the 10 minute intervention
|
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Borg's Rating of Perceived Exertion Scale (RPE) or Modified Borg Scale
Tidsramme: before and immediately after the 10 minute intervention
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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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. november 2017
Primær færdiggørelse (Faktiske)
20. marts 2018
Studieafslutning (Faktiske)
30. april 2018
Datoer for studieregistrering
Først indsendt
12. april 2018
Først indsendt, der opfyldte QC-kriterier
18. maj 2018
Først opslået (Faktiske)
31. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. maj 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. maj 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Whole body vibration glucose
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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