Heart Cycle Prestudy (PreGEx)
Heart Cycle Prestudy Guided Exercise (GEx) for Coronary Artery Disease Patients (CAD) "GEx Home Application Testing"
調査の概要
詳細な説明
During the rehabilitation process (phase II) of patients with coronary heart disease (CAD) 30 patients are recruited and are made familiar with the new Guided Exercise (GEx) training system during exercise training; they are supervised and provided with training instructions by a medicine for 3 times a week 3 weeks long. At the beginning and at the end of the study the patient has to undergo several tests of the clinical routine such as a cardiopulmonary test (CPX), echocardiography and lactate measurement;additionally, this test will be registered by the system to obtain information about the detection of heart rate rise for example. Data will be analyzed for quality of heart rate measurement and data acquisition by the device.
In a second step the GEx system is handed to these 30 patients when they leave in-patient cardiac rehabilitation (CR). The pre-trial serves to gather information about the practicability and technical problem during real-life use. Therefore at home these 30 patients will continue with moderate endurance training like walking, cycling or running while wearing the GEx system three times a week for 3 weeks. After three weeks patients will come back to the clinic to undergo the end examination and to report the feasibility of usage. The ECG data and breathing frequency data will be analyzed to see if data are recorded and transmitted well in regard to technical problems.
If accurate and safe data are received the following GEx- main- trial (ID 11-020) will investigate the GEx- system for CAD patients in regard to improvement of physical capacities obtained in long term adherence to home based rehabilitation programs (phase III) including feedback to patients compared to national standard rehabilitation.
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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North Rhine Westphalia
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Aachen、North Rhine Westphalia、ドイツ、52074
- Medical Clinic I, University Hospital Aachen
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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:
- Patients suffering from CAD and presenting after an acute myocardial infarction or elective coronary intervention
- Patients willing to exercise
- With a preference for walking/ cycling/ running
- Eligible for the normal local rehabilitation program
- Contractually capable and mentally able to understand and follow the instructions of the study personnel
- Able to give informed consent
Exclusion Criteria:
- Ejection Fraction at discharge from hospital < 30%
- Unwillingness or lack of capability to handle the device
- Unable to perform exercise
- Severe congestive heart failure NYHA III/IV
- Severe valve disease without replacement
- Slow healing wounds
- Women who are pregnant or breastfeeding
- Refusal of device
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：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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：GEx Training
CAD Patients in cardiac rehabilitation phase II (inpatient) and phase III (at home)in order to analyze data for quality of heart rate measurement and data acquisition by device as well as for practicability and technical problems at home.
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30 CAD patients will wear the GEx system while they are trained during inpatient cardiac rehabilitation (phase II) in order to evaluate accuracy and safety of data like heart rate, breathing, ECG three times a week for about three weeks.
In a second step these patients train at home (phase III) in order to evaluate practicability and technical problems of the GEx device three times a week for about three weeks.
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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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Evaluation of accuracy and safety of data of the GEx system received during in-patient cardiac rehabilitation (phase II) and evaluation of practicability and technical problems in real- life use during cardiac rehabilitation at home (phase III).
時間枠：6 Months
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The GEx system is evaluated during in-patient cardiac rehabilitation supervised by cardiologists in order to analyze data for quality of heart rate measurement and data acquisition by device.
30 Patients undergo moderate training exercise like walking, cycling or running three times a week three weeks long.
In a second step practicability and technical problems are tested during continuation of the moderate training of the patient at home.
The Evaluation is performed by CPX, lactate measurement, 2D-Echo, questionnaires and device data like heart rate and breathing rate.
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6 Months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Patrick Schauerte, Professor MD、University Hospital Aachen, Department of Cardiology
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 (見積もり)
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
キーワード
その他の研究ID番号
- 11-094
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。