- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02448030
Effects of Functional Electrical Stimulation on Metaboreflex Activation in Healthy Individuals
May 18, 2015 updated by: 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Beatriz Dr Schaan, PhD
- Phone Number: +55 5193138534
- Email: beatrizschaan@gmail.com
Study Contact Backup
- Name: Aline Dr Macedo, Graduate
- Phone Number: +55 5197016966
- Email: alinechagastelles@gmail.com
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90035-003
- Recruiting
- Hospital de Clínicas de Porto Alegre
-
Principal Investigator:
- Beatriz Schaan, PhD
-
Contact:
- Aline Macedo, Graduate
- Phone Number: +55 51 97016966
- Email: alinechagastelles@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
Placebo Comparator: 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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-).
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5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum muscle strength
Time Frame: 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.
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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
Time Frame: 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-
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Beatriz Dr Schaan, PhD, Hospital de Clínicas de Porto Alegre
- Study Chair: Aline Macedo, Graduate, Federal University of Rio Grande do Sul
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD. Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):254-60. doi: 10.1097/HJR.0b013e328339b5a2.
- Mitchell JH. J.B. Wolffe memorial lecture. Neural control of the circulation during exercise. Med Sci Sports Exerc. 1990 Apr;22(2):141-54. No abstract available.
- Rowell LB, O'Leary DS. Reflex control of the circulation during exercise: chemoreflexes and mechanoreflexes. J Appl Physiol (1985). 1990 Aug;69(2):407-18. doi: 10.1152/jappl.1990.69.2.407.
- Kim JK, Sala-Mercado JA, Rodriguez J, Scislo TJ, O'Leary DS. Arterial baroreflex alters strength and mechanisms of muscle metaboreflex during dynamic exercise. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1374-80. doi: 10.1152/ajpheart.01040.2004. Epub 2004 Nov 11.
- Karavidas AI, Raisakis KG, Parissis JT, Tsekoura DK, Adamopoulos S, Korres DA, Farmakis D, Zacharoulis A, Fotiadis I, Matsakas E, Zacharoulis A. Functional electrical stimulation improves endothelial function and reduces peripheral immune responses in patients with chronic heart failure. Eur J Cardiovasc Prev Rehabil. 2006 Aug;13(4):592-7. doi: 10.1097/01.hjr.0000219111.02544.ff.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
May 11, 2015
First Submitted That Met QC Criteria
May 14, 2015
First Posted (Estimate)
May 19, 2015
Study Record Updates
Last Update Posted (Estimate)
May 20, 2015
Last Update Submitted That Met QC Criteria
May 18, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 14-0359
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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