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Effects of Functional Electrical Stimulation on Metaboreflex Activation in Healthy Individuals

18 mei 2015 bijgewerkt door: Beatriz D'Agord Schaan, Hospital de Clinicas de Porto Alegre

Effects of Functional Electrical Stimulation Compared to Isometric Exercise on Metaboreflex Activation in Healthy Individuals: Randomized Crossover Clinical Trial

Cardiovascular exercise adjustments are required during in order to redistribute blood flow from non-exercising vascular areas to active muscles. This hemodynamic adjustments, which are partially mediated by mechanosensitive and metabosensitive reflexes, ultimately increase oxygen and nutrient delivery to exercising muscle tissues (Mitchell, 1990). Static handgrip exercise has been shown to induce alterations in the arterial baroreflex function (Kim, 2005) and activation of muscle metaboreflex that increases arterial blood pressure and peripheral vasoconstriction, respectively. Functional electrical stimulation (FES) treatment used in physical therapy in patients who are unable to tolerate conventional exercise showed to be a good alternative for muscle strengthening (Sbruzzi, 2010) and to improve metabolic abnormalities (Karavidas, 2006). However, the effect of FES on metaboreflex activation in healthy individuals has never been investigated. Therefore, this study aims to evaluate the metaboreflex activation induced by FES in upper and low limbs in healthy individuals, and also to compare their results with the effects caused by isometric exercise.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

All participants will be invited to attend four separate days for completion of the study protocols. On the first day, the metaboreflex activation in upper limb will be randomly assigned to isometric exercise or FES intervention. On the second day, at least two days apart, random isometric exercise or FES intervention will be performed in the upper limb. On the third day, at least one week apart, all participants will be assigned to perform metaboreflex in a lower limb induced by isometric exercise or FES intervention. On the fourth day, at least two days apart, random isometric exercise or FES intervention will be performed in a lower limb. To evaluate the isometric exercise and FES intervention the post-exercise ischemia will be randomly performed to evaluate the accumulation of metabolites in response to activated limb (PECO +) and evaluation control without ischemia (PECO-). The experiments between PECO+ and PECO- will be separated by a 30 min interval. During isometric exercise and FES protocols the blood flow and peripheral vascular resistance will be assessed by venous occlusion plethysmography. Fatigue will be determined every minute by the 10-point Borg scale to assess rate of perceived exertion and by blood lactate. Blood lactate will be evaluated through capillary action at pre, immediately post exercise and at 5 minutes during the recovery period. Hemodynamic variables such as BP and HR will be recorded every minute during the protocols.

Studietype

Ingrijpend

Inschrijving (Verwacht)

20

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Brazilië
    • RS
      • Porto Alegre, RS, Brazilië, 90035-003
        • Werving
        • Hospital De Clinicas De Porto Alegre
        • Hoofdonderzoeker:
          • Beatriz Schaan, PhD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

35 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Healthy individuals
  • Both genders
  • Aged 35-70 years
  • Sedentary
  • Not using continuous medications

Exclusion Criteria:

  • Cardiovascular disease
  • Neurological disease
  • Malignant disease
  • Peripheral vascular disorders (varicose veins or deep vein thrombosis)
  • Peripheral sensitivity alterations
  • Contraindication to performing physical exercise
  • Refusal to sign the consent form

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Functional electric stimulation
Other: The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively.
Ander: Functional electric stimulation
The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively. The stimulation frequency will be 20 Hz. The pulse width used will be 0.5 milliseconds and the contraction time will be 60 seconds (TON: 60s) with a 1-second rest interval (TOFF: 1s). The total time of application will be determined for the muscle fatigue that will be evaluated by 10-point Borg scale and by the measurement of lactate accumulation that must not exceed 30 minutes. The intensity will be adjusted individually, taking into account the patient's ability to promote the full flexion of the wrist / knee extension and comfort during contractions. Along with the application of FES a 1 Kg overload will be applied to intensify the fatigue time.
Andere namen:
  • FES
Placebo-vergelijker: Isometric exercise
For the upper limbs the isometric contraction exercise with handgrip will be performed for 5 minutes with 30% of loading, previously measured by maximum voluntary contraction test.
Ander: Isometric exercise
For the upper limbs the isometric contraction exercise with handgrip will be performed for 5 minutes with 30% of loading, previously measured by maximum voluntary contraction test. For the lower limbs the knee extension exercise will be conducted in a training station. The SBP, DBP, MBP and HR will be recorded through the protocols. Fatigue will be determined every minute by the 10-point Borg scale and by measurement of lactate accumulation before, immediately after the protocol, and 5 minutes during the recovery period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Forearm and calf blood flow change
Tijdsspanne: 5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)
When performed the protocol with FES measurements will be taken for 3 minutes of rest (in both PECO+ and PECO-), 5 minutes of exercise (when PECO-) or to fatigue (when PECO +), during the 3 minutes of occlusion (when PECO +) and 3 minutes final recovery (in both PECO+ and PECO-). When performed the protocol with isometric exercise measurements will be at 3 minutes basal (in both PECO+ and PECO-), 3 minutes of exercise (in both PECO+ and PECO-), 3 minutes of occlusion when PECO + and 3 minutes of ultimate recovery (in both PECO+ and PECO-).
5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximum muscle strength
Tijdsspanne: The maximum peak strength will be measured 3 times with 1 minute interval between each measurement before a session of isometric exercise
Before starting the evaluations of blood flow, the maximum peak strength is measured three times with 1 minute interval between each measurement, after is calculated 30% of the maximum value and the determined load exercise.
The maximum peak strength will be measured 3 times with 1 minute interval between each measurement before a session of isometric exercise
Peripheral vascular resistance
Tijdsspanne: It is calculated using data obtained from blood flow and mean arterial pressure in the protocols at 3 minutes in both PECO+ and PECO-
Ratio between the mean arterial pressure (MBP) and muscle blood flow.
It is calculated using data obtained from blood flow and mean arterial pressure in the protocols at 3 minutes in both PECO+ and PECO-

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital de Clinicas de Porto Alegre

Onderzoekers

  • Hoofdonderzoeker: Beatriz Dr Schaan, PhD, Hospital De Clinicas De Porto Alegre
  • Studie stoel: Aline Macedo, Graduate, Federal University of Rio Grande do Sul

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2015

Primaire voltooiing (Verwacht)

1 december 2015

Studie voltooiing (Verwacht)

1 maart 2016

Studieregistratiedata

Eerst ingediend

11 mei 2015

Eerst ingediend dat voldeed aan de QC-criteria

14 mei 2015

Eerst geplaatst (Schatting)

19 mei 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

20 mei 2015

Laatste update ingediend die voldeed aan QC-criteria

18 mei 2015

Laatst geverifieerd

1 mei 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 14-0359

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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