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Clinical Trials/NCT02448030
NCT02448030UnknownEarly Phase 1

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

Hospital de Clinicas de Porto Alegre2 sites in 1 country20 target enrollmentStarted: March 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Early Phase 1
Enrollment
20
Locations
2
Primary Endpoint
Forearm and calf blood flow change

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
35 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Functional electric stimulation

Experimental

Other: The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively.

Intervention: Functional electric stimulation (Other)

Isometric exercise

Placebo Comparator

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.

Intervention: Isometric exercise (Other)

Outcomes

Primary Outcomes

Forearm and calf blood flow change

Time Frame: 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-).

Secondary Outcomes

  • Peripheral vascular resistance(It is calculated using data obtained from blood flow and mean arterial pressure in the protocols at 3 minutes in both PECO+ and PECO-)
  • Maximum muscle strength(The maximum peak strength will be measured 3 times with 1 minute interval between each measurement before a session of isometric exercise)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Beatriz D'Agord Schaan

Doctor

Hospital de Clinicas de Porto Alegre

Study Sites (2)

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