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Functional Electrical Stimulation (FES) Exercise Training in Hemodialysis Patients

2017年9月19日 更新者:University of Illinois at Urbana-Champaign

Efficacy of Functional Electrical Stimulation Exercise Training in Hemodialysis Patients

Both strength training and endurance exercise training are commonly prescribed to improve strength and function in patients with physical limitations caused by chronic disease or disability including chronic kidney disease (CKD). Individuals with CKD often have low physical function due to progressive declines in the performance of their kidneys. The low physical function leads to physical inactivity, which exacerbates these functional declines and promotes cardiovascular disease and bone disorders. In addition, severe functional limitations in some patients prevent them from exercising at a great enough intensity to provide significant benefits. As a result, alternative strategies are needed to maximize the benefits of exercise while decreasing injury risk.

調査の概要

状態

終了しました

詳細な説明

Both strength training and endurance exercise training are commonly prescribed to improve strength and function in patients with physical limitations caused by chronic disease or disability including chronic kidney disease (CKD). Individuals with CKD often have low physical function due to progressive declines in the performance of their kidneys. The low physical function leads to physical inactivity, which exacerbates these functional declines and promotes cardiovascular disease and bone disorders. In addition, severe functional limitations in some patients prevent them from exercising at a great enough intensity to provide significant benefits. As a result, alternative strategies are needed to maximize the benefits of exercise while decreasing injury risk.

A new form of exercise, functional electrical stimulation (FES)-enhanced cycling has been shown to increase muscle size and strength in patients with severe disabilities, particularly spinal cord injury (SCI). It is based on the application of electrical stimulation to the nerves that innervate the paralyzed weak muscles in order to generate muscle contraction. FES has been used to stimulate leg muscles to pedal a cycle or to enable partial weight-supported walking as an activity based rehabilitation therapy. FES cycling involves exercising using a motor-assisted cycle coupled with electrical stimulation to up to five muscles in the leg. There are well-documented benefits of FES-induced exercise in SCI patients including clinically significant increases in muscle mass, blood flow, bone density, and bowel and bladder function. A few pilot studies have also demonstrated that FES therapy has the potential to improve function in other disabled populations, including chronic heart failure and stroke patients. However, its effects in other populations with significant physical impairments, including CKD patients, have yet to be established.

The objective of the proposed research is to evaluate the effects of FES-cycling training on measures related to physical function, quality of life (QOL), heart disease, and bone health in patients with renal failure receiving dialysis therapy.

研究の種類

介入

入学 (実際)

9

段階

  • 適用できない

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

    • Illinois
      • Urbana、Illinois、アメリカ、61801
        • Champaign Urbana Dialysis Center

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

31年~85年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Age 31-85 years
  2. Must receive hemodialysis treatment at least 3 days per week
  3. Must be willing to be randomized to the control or FES-cycle groups
  4. Must receive medical clearance from a Nephrologist at their dialysis clinic to participate
  5. Must have evidence of impaired mobility on the FES Screening Form, attached. The FES Screening Form inclusion criterion consist of a questionnaire of five tasks with a relative difficulty scale for the completion of each task. Participants will be included in the study if they indicate "some" or more difficulty at any task on the questionnaire.

Exclusion Criteria:

  1. On dialysis treatment for less than 3 months.
  2. Body weight of greater than 400 pounds. (weight limitations on the DXA table)
  3. Unstable angina, recent (less than 3 months) myocardial infarction or stroke (these conditions may not enable the patient to tolerate the proposed exercise training).
  4. Implanted electronic pacing or defibrillation device, vagus nerve stimulator, or unstable vital signs.(the safety of electrical stimulation under these conditions is not known).
  5. Metal implants underneath or near the muscle groups which are to be stimulated.
  6. Pregnancy (the safety of stimulation during pregnancy is not known) - a section on the ICD has been created for women to initial to indicate they are NOT pregnant or planning on becoming pregnant over the course of the study.
  7. Lower limb amputation.

On the PAR-Q form, if the participant answers YES to the question: "Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?", they will be excluded from the study.

We will also use answers on the Medical History Form to help us evaluate the exclusion criteria. Answers to the following questions will either be exclusionary, or require further follow-up with a physician prior to being allowed to participate:

Question 1: "Do you ever get chest pains while at rest and/or during exertion?", and Question 4: "…was your heart attack within the last year?" An answer of YES to either question will require that the individual obtain a comprehensive physical exam by their physician prior to being allowed to participate.

Question 10: Has your physician ever specifically told you not to do "heavy" or "hard" exercise? An answer of YES will require a physical exam.

Under "Medical History" (top of page 2 of Medical History Form), or "Present Symptoms Review" (top of page 3) a check by "chest pain or pressure" will require a physical exam.

Under "Present Symptoms Review (top of page 3), a check by any of the following will lead to exclusion: Implanted electronic pacing or defibrillation device; vagus nerve stimulator; metal implants in the legs; or unstable vital signs.

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:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:FES exercise
Participants will receive FES
receive FES while exercising
偽コンパレータ:Mock FES exercise
participant will receive Mock FES
participants will receive Mock FES

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
physical function
時間枠:Three months
muscle strength, functional fitness testing, shuttle walk test, balance and gait kinematics
Three months

その他の成果指標

結果測定
メジャーの説明
時間枠
quality of life (QOL)
時間枠:three months
questinnaire
three months
heart disease
時間枠:three months
arterial and cardiac measures
three months
bone health
時間枠:three months
DXA scan for bone mineral density, body composition, vascular calcification
three months

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:Kenneth Wilund, PhD、UIUC

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

2012年12月1日

一次修了 (実際)

2015年12月1日

研究の完了 (実際)

2016年11月1日

試験登録日

最初に提出

2013年4月17日

QC基準を満たした最初の提出物

2013年10月4日

最初の投稿 (見積もり)

2013年10月8日

学習記録の更新

投稿された最後の更新 (実際)

2017年9月20日

QC基準を満たした最後の更新が送信されました

2017年9月19日

最終確認日

2014年8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

  • IRB#: 12309

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。

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