Physical Activity Immediately After Acute Cerebral Ischemia 3
Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much
Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.
Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.
Accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.
Another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.
Clarification of the optimal dose of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.
The purpose of the project is to investigate feasibility of treadmill training on a weight-bearing treadmill in the acute phase after admission after an ischemic stroke. Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and whether it changes with treadmill training.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Hillerød、デンマーク、3400
- 募集
- Hillerød Hospital
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コンタクト:
- Anna Maria Strømmen, MD
- 電話番号:+4548297353
- メール:anna.maria.stroemmen@regionh.dk
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主任研究者:
- Anna Maria Strømmen, MD
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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 admitted with acute ischemic stroke
- age > 18 years
- first stroke or only minor invalidity from previous strokes (mRS 0-2)
- truncal stability
- SSS score for arm and leg: 10 out of 12 points
Exclusion Criteria:
- symptoms attributable to other diseases than ischemic stroke
- debut of symptoms > 48 h prior to admission
- consent not given < 24 h of admission
- pregnancy or lactation
- isolation
- blood sampling generally not possible
- allergy due to accelerometer wear
- ulcers or other skin diseases in the area of accelerometer placement
- unstable cardiologic condition (AMI etc.)
- acute high and sustained resting systolic blood pressure where treatment is necessary
- acute heart rhythm disorder where treatment is necessary
- unable to cooperate
- significant orthopedic conditions (fractures etc.)
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
- 割り当て:非ランダム化
- 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 |
|---|---|
|
実験的:High dose training
2 x 30 minutes/day on a weight-bearing treadmill
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weight-bearing treadmill, pulse reserve increase of 50%
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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 |
|---|---|---|
|
Level of inflammation, under, during and after treadmill training
時間枠:up to 5 days
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Biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Necrosis Factor(TNF)-alpha, C-Reactive Protein (CRP), IL-1ra, IL-10, fasting-insulin, fasting-glucose
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up to 5 days
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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 |
|---|---|---|
|
Correlation of biomarker level
時間枠:up to 5 days
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Correlation with time, activity counts on an accelerometer, Scandinavian Stroke Scale Score (SSS), National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS), Assessment of Motor and Process Skills (AMPS), Bergs Balance test, age, Body Mass Index and sex
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up to 5 days
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Feasibility
時間枠:up to 5 days
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Whether it is feasible/possible to train patients on a treadmill in the acute phase after ischemic stroke; eg.
whether patients are too exhausted to train twice daily, experience complications during training such as nausea or dizziness and therefore can't complete the training programme.
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up to 5 days
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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