HF患者におけるNMESは入院後の機能回復を改善する (NeuHFRecover)
入院後の機能回復を促進する心不全患者の神経筋電気刺激 (NeuHF-Recover)
調査の概要
詳細な説明
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
-
-
Vermont
-
Burlington、Vermont、アメリカ、05405
- University of Vermont Medical Center
-
-
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
説明
包含基準:
- 50～90歳
- HFpEFの臨床診断は入院中に積極的に管理されている
- 医療センターから30マイル以内に住んでいる
- インフォームドコンセントを実行できる
除外基準:
- 関節リウマチまたはその他の炎症性/自己免疫疾患
- がん（非黒色腫皮膚がんまたは低悪性度前立腺がんを除く）
- 重度の認知症/アルツハイマー病
- 運動による末梢血管疾患の制限
- 脳血管イベントに関連する神経筋疾患または神経筋機能不全
- BMI ≥40 kg/m2
- 下肢の血栓または植込み型除細動器またはペースメーカー
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：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：神経筋電気刺激
大腿四頭筋の神経筋電気刺激。
45 分、週 5 日
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両側の大腿四頭筋刺激
|
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介入なし：コントロール
治療管理がない
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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 |
|---|---|---|
|
徒歩6分の距離 (6MW)
時間枠：退院（1日以内）から退院後4週間に変更
|
6 MW は、肺および心臓疾患を持つ患者の心肺機能を評価するために開発され、心不全患者で検証されています。
患者が標準コースを6分間で歩ける距離を評価します。
|
退院（1日以内）から退院後4週間に変更
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
物理的パフォーマンスが短いバッテリー
時間枠：退院（1日以内）から退院後4週間に変更
|
ショート フィジカル パフォーマンス バッテリーは、バランス、歩行速度、椅子から立つ能力を評価する 3 つのタスクで構成されています。
各領域のスケールの単位は 0 ～ 4 の範囲で、合計スコアは 0 ～ 12 であり、スコアが高いほど身体機能が良好であることを示します。
|
退院（1日以内）から退院後4週間に変更
|
|
医療結果の短いフォーム 36
時間枠：退院（1日以内）および退院後4週間
|
Medical Outcomes Short Form 36 は、自己申告による健康状態と身体機能の状態を評価するアンケートです。
このアンケートには、健康の 8 つのサブドメインを反映する 36 の質問が含まれています。
各ドメインのスコアは、各サブドメインの質問の加重合計を表します。
各スケールは、各質問の重みが等しいという仮定に基づいて、0 ～ 100 のスケールに直接変換されます。
この測定値は、すべてのサブドメインにわたって計算された合計スコアを表します。
スコアが低いほど全体的な健康状態が悪化していることを表し、スコアが高いほど健康状態が良好であることを表します。
|
退院（1日以内）および退院後4週間
|
|
Katz 日常生活活動における自立度指数
時間枠：退院（1日以内）および退院後4週間
|
一般にカッツ ADL と呼ばれる日常生活活動自立度のカッツ指数は、日常生活活動を自立して実行するクライアントの能力の尺度として機能状態を評価するのに最も適切な手段です。
臨床医は通常、日常生活活動を実行する上での問題を検出し、それに応じてケアを計画するためにこのツールを使用します。
この指数は、入浴、着替え、トイレ、移動、失禁、食事の 6 つの機能におけるパフォーマンスの適切さをランク付けします。
クライアントは、6 つの機能ごとに独立性について「はい」/「いいえ」でスコア付けされます。
スコア 6 は完全な機能障害を示し、4 は中程度の機能障害を示し、2 以下は重度の機能障害を示します。
|
退院（1日以内）および退院後4週間
|
|
Lawton Instrumental Activities of Daily Living (IADL) Scale
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering have been excluded. Since men regularly complete food preparation, housekeeping, and laundering tasks, they were scored in all 8 domains as well. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and men. |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 Question 1
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
Responses to Q1.
In general, would you say your health is:
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 Question 2
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
Responses to Q2.
Compared to one year ago, how would you rate your health in general now?
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3a
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3a.
Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports.
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3b
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3b.
Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf.
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3c
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3c.
Lifting or carrying groceries.
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3d
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3d.
Climbing several flights ofstairs
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3e
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3e.
Climbing one flight of stairs
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3f
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3f.
Bending, kneeling, or stooping
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3g
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3g.
Walking more than a mile
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3h
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3h.
Walking several blocks
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3i
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3i.
Walking one block
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 3j
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3j.
Bathing or dressing yourself
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 4a
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4a.
Cut down the amount of time you spent on work or other activities
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 4b
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4b.
Accomplished less than you would like
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 4c
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4c.
Were limited in the kind of work or other activities
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 4d
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4d.
Had difficulty performing the work or other activities (for example, it took extra effort)
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 5a
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5a.
Cut down the amount of time you spent on work or other activities
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 5b
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5b.
Accomplished less than you would like
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 5c
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5c.
Didn't do work or other activities as carefully as usual
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 6
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
Responses to Q6.
During the past 4weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors or groups?
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 7
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
Responses to Q7.
How much bodily pain have you had during the past four weeks?
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 Question 8
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
Responses to Q8.
During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
|
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 9a
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9a. Did you feel full of pep? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 9b
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9b. Have you been a very nervous person? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 9c
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9c. Have you felt so down in the dumps that nothing could cheer you up? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 9d
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9d. Have you felt calm and peaceful? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 9e
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9e. Did you have a lot of energy? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 Question 9f
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9f. Have you felt down hearted and blue? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 9g
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9g. Did you feel worn out? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 Question 9h
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9h. Have you been a happy person? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 Question 9i
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9i. Did you feel tired? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 9j
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9j. During the past 4weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 10a
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
How TRUE or FALSE is each of the following statements for you: Responses to Q10a. I seem to get sick a little easier than other people |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 Question 10b
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
How TRUE or FALSE is each of the following statements for you: Responses to Q10b. I am as healthy as anybody I know |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 10c
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
How TRUE or FALSE is each of the following statements for you: Responses to Q10c. I expect my health to get worse |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
|
Medical Outcomes Short Form 36 Question 10d
時間枠：Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
How TRUE or FALSE is each of the following statements for you: Responses to Q10d. My health is excellent |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。