Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients (ACE-HD)
調査の概要
詳細な説明
Patients with kidney failure requiring hemodialysis (HD) treatment die at excessively high rates, despite advances in HD techniques and pharmacological therapies. This indicates additional therapeutic strategies are needed. Intradialytic exercise (IDEX, exercise during HD treatment) represents a low-cost, easy to administer treatment strategy that could potentially improve cardiovascular function, physical function and quality of life. However, nephrologists rarely counsel their patients to increase their physical activity levels or to exercise during HD treatment, in part due to a lack of understanding of IDEX knowledge.
Providing more robust evidence for the safety and effectiveness of IDEX, as well as evaluating the impact of exercising early vs late in the treatment, could help improve adoption of exercise training as a standard practice in HD clinics.
Therefore, investigators plan to examine the impact of IDEX and its timing during treatment (1st vs 3rd hour) on blood pressure and adverse symptoms in HD patients. The proposed study also includes various cardiovascular measures to allow deeper mechanistic understanding of cardiovascular physiology with IDEX. Such understanding will significantly advance the field and lead to improved therapeutic approaches, including exercise training, which may help mediate the deleterious effects of renal failure.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Illinois
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Urbana、Illinois、アメリカ、61801
- University of Illinois at Urbana-Champaign
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists
Exclusion Criteria:
- Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.
研究計画
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：クロスオーバー割り当て
- 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 |
|---|---|
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実験的：Standard Hemodialysis
Participants will be monitored during their normal hemodialysis treatment with no intervention administered
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Participants will receive a standard hemodialysis treatment during the study period
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実験的：Hemodialysis with Exercise (1-st hr)
Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 1-st hour into treatment
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Participants will receive a standard hemodialysis treatment during the study period
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
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実験的：Hemodialysis with Exercise (3-rd hr)
Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 3-rd hour into treatment
|
Participants will receive a standard hemodialysis treatment during the study period
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
|
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 |
|---|---|---|
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Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment
時間枠：Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
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Systolic and diastolic blood pressure will be measured using an automated blood pressure cuff attached to the clinic dialysis machine
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Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
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Changes in cardiac output (mL/min) measured by thoracic impedance technique
時間枠：Continous throughout a dialysis treatment (approximately 4 hours)
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Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.
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Continous throughout a dialysis treatment (approximately 4 hours)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)
時間枠：Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
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A finger cuff will be placed around the non-dialyzing finger and will measure the change in peripheral blood pressure from successive beats continuously.
Total peripheral resistance will be estimated using measured cardiac output and peripheral blood pressure.
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Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
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Hypotensive event assessment measured by a symptom questionnaire
時間枠：Throughout and up to 5 hours after completion of a dialysis treatment
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The presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.
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Throughout and up to 5 hours after completion of a dialysis treatment
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協力者と研究者
捜査官
- 主任研究者：Kenneth Wilund, PhD、University of Illinois at Urbana-Champaign
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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