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Effects of Functional Electrical Stimulation on Metaboreflex Activation in Healthy Individuals

18 mai 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

20

Phase

  • Première phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Brésil
    • RS
      • Porto Alegre, RS, Brésil, 90035-003
        • Recrutement
        • Hospital De Clinicas De Porto Alegre
        • Chercheur principal:
          • Beatriz Schaan, PhD
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

35 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Autres noms:
  • FES
Comparateur placebo: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Forearm and calf blood flow change
Délai: 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 +)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Maximum muscle strength
Délai: 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
Délai: 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-

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital de Clinicas de Porto Alegre

Les enquêteurs

  • Chercheur principal: Beatriz Dr Schaan, PhD, Hospital De Clinicas De Porto Alegre
  • Chaise d'étude: Aline Macedo, Graduate, Federal University of Rio Grande do Sul

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2015

Achèvement primaire (Anticipé)

1 décembre 2015

Achèvement de l'étude (Anticipé)

1 mars 2016

Dates d'inscription aux études

Première soumission

11 mai 2015

Première soumission répondant aux critères de contrôle qualité

14 mai 2015

Première publication (Estimation)

19 mai 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

20 mai 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mai 2015

Dernière vérification

1 mai 2015

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 14-0359

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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