Effects of Functional Electrical Stimulation on Metaboreflex Activation in Healthy Individuals
2015年5月18日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
20
段階
- 初期フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
RS
-
Porto Alegre、RS、ブラジル、90035-003
- 募集
- Hospital de Clínicas de Porto Alegre
-
主任研究者：
- Beatriz Schaan, PhD
-
コンタクト：
- Aline Macedo, Graduate
- 電話番号：+55 51 97016966
- メール：alinechagastelles@gmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
35年～70年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
|
|
プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Forearm and calf blood flow change
時間枠：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 +)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum muscle strength
時間枠：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
時間枠：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-
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Beatriz Dr Schaan, PhD、Hospital de Clínicas de Porto Alegre
- スタディチェア：Aline Macedo, Graduate、Federal University of Rio Grande do Sul
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年3月1日
一次修了 (予想される)
2015年12月1日
研究の完了 (予想される)
2016年3月1日
試験登録日
最初に提出
2015年5月11日
QC基準を満たした最初の提出物
2015年5月14日
最初の投稿 (見積もり)
2015年5月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月20日
QC基準を満たした最後の更新が送信されました
2015年5月18日
最終確認日
2015年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 14-0359
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Functional electric stimulationの臨床試験
-
Consorci d'Atenció Primària de Salut de l'EixampleMedtronic完了
-
Biotronik SE & Co. KG完了
-
Washington University School of MedicineMerck Sharp & Dohme LLC完了