Reduction of Blood FlowEarly Phase 1NCT02448030
Effects of Functional Electrical Stimulation on Metaboreflex Activation in Healthy Individuals
A Early Phase 1 study testing Functional electric stimulation and Isometric exercise in people with Reduction of Blood Flow, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Reduction of Blood Flow
- What is being tested?
- Functional electric stimulation and Isometric exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Mar 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
- Both genders
- Aged 35-70 years
- Sedentary
- Not using continuous medications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Aline Macedo, Graduate, +55 51 97016966, alinechagastelles@gmail.com
Beatriz Schaan, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Reduction of Blood Flow
- Being tested
- Functional electric stimulation, Isometric exercise
- Keywords
- Metaboreflex, Variation of blood flow, Functional electrical stimulation, Isometric exercise.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional electric stimulationOther
Also called FES
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.
Isometric exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Functional electric stimulation |
| 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. Receives: Other: Isometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm and calf blood flow change
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-).
Measured: 5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)
Secondary outcomes (2)
Maximum muscle strength
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.
Measured: 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
Ratio between the mean arterial pressure (MBP) and muscle blood flow.
Measured: It is calculated using data obtained from blood flow and mean arterial pressure in the protocols at 3 minutes in both PECO+ and PECO-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Reduction of Blood FlowStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz D'Agord Schaan, Hospital de Clinicas de Porto Alegre
- Investigators
- Beatriz Dr Schaan, PhD, Principal investigator, Hospital de Clinicas de Porto AlegreAline Macedo, Graduate, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448030
- Sponsor's protocol ID
- 14-0359
- Status last verified
- May 2015
- First submitted
- 11 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 2192221Rowell 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.
PubMed 2228848Kim 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.
PubMed 15539416Sbruzzi 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.
PubMed 20560163Karavidas 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.
PubMed 16874150
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Electrical Stimulation Compared to Isometric Exercise on Metaboreflex Activation in Healthy Individuals: Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT02448030
- Acronym / sponsor ID
- 14-0359
- Conditions
- Reduction of Blood Flow
- Keywords
- Metaboreflex, Variation of blood flow, Functional electrical stimulation, Isometric exercise.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional electric stimulation | Experimental | Other: Functional electric stimulationOther: The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively. |
| Isometric exercise | Placebo comparator | Other: Isometric exerciseFor 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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy individuals
- Both genders
- Aged 35-70 years
- Sedentary
- Not using continuous medications
Key exclusion criteria (7 listed)
- Cardiovascular disease
- Neurological disease
- Malignant disease
- Peripheral vascular disorders (varicose veins or deep vein thrombosis)
- Peripheral sensitivity alterations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional electric stimulationAlso: FESThe 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 | Functional electric stimulation |
| Isometric exerciseFor 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. | Other | Isometric exercise |
Primary outcome
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-).
2 secondary outcomes
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
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-
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Background: PubMed 2192221Mitchell 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.
- Background: PubMed 2228848Rowell 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.
- Background: PubMed 15539416Kim 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.
- Background: PubMed 20560163Sbruzzi 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.
- Background: PubMed 16874150Karavidas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Dr Schaan, PhD principal investigator
Hospital de Clinicas de Porto Alegre
Aline Macedo, Graduate study chair
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Functional electric stimulation and Isometric exercise in people with Reduction of Blood Flow, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Dr Schaan, PhD (+55 5193138534, beatrizschaan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm and calf blood flow change (time frame: 5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02448030, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.