The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort
2020年11月10日 更新者:Jong Sze Chin、Tan Tock Seng Hospital
Research has shown that rehabilitation at almost any Body Mass Index (BMI) level leads to positive functional outcomes.
Some data demonstrating that gains are often more rapid at BMI above "normal".
The aim of this study is to investigate the association between BMI and the functional progress of all patients admitted to Tan Tock Seng Tertiary Rehabilitation Center.
調査の概要
研究の種類
観察的
入学 (実際)
247
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
-
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Singapore、シンガポール、570186
- Tan Tock Seng Hospital
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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
18年歳以上 (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
サンプリング方法
非確率サンプル
調査対象母集団
All patient admitted to Tan Tock Seng Tertiary Rehabilitation Centre and fulfilled the inclusion criteria within the study period will be consented to the study.
説明
Inclusion Criteria:
- clinical strokes (ischaemic or haemorrhagic) diagnosed by acute neurologists or neurosurgeons and confirmed on computerized tomography (CT) or Magnetic resonance imaging (MRI) brain imaging
- aged 18 years and above
- admitted directly from acute stroke units
- able to provide informed consent by self or by next of kin in incompetence patient
- must receive physical therapy (either physiotherapy, occupational therapy or speech therapy) at least 5 times a week with each session at least 30 minutes
Exclusion Criteria:
- rehabilitation was not the primary reason for the inpatient admission
- failure to complete the rehabilitation program due to either an acute transfer off rehabilitation or a discharge against medical advice
- incomplete or missing Body Mass Index (BMI) or Functional Independence Measure (FIM) data
- patients who were not of Asian ethnicity
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
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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Functional Independence Measure (FIM) on Admission
時間枠:Functional Independence Measure (FIM) was measured within 72 hours of admission
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Functional Independence Measure (FIM), the main primary outcome measure during rehabilitation was measured within 72 hours of admission and discharge by rehabilitation therapists all of whom were trained and certified in the use of the FIM.
The FIM is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition).
Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
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Functional Independence Measure (FIM) was measured within 72 hours of admission
|
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Functional Independence Measure (FIM) on Discharge
時間枠:Functional Independence Measure (FIM) was measured within 72 hours of discharge.
|
Functional Independence Measure (FIM), the main primary outcome measure during rehabilitation was measured within 72 hours of admission and discharge by rehabilitation therapists all of whom were trained and certified in the use of the FIM.
The FIM is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition).
Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
|
Functional Independence Measure (FIM) was measured within 72 hours of discharge.
|
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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Mean Functional Independence Measure (FIM) Gain
時間枠:Within 72 hours
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Mean FIM gain, calculated as [Td-FIM - Ta-FIM] points
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Within 72 hours
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Mean Functional Independence Measure (FIM) efficiency
時間枠:Through study completion, an average of 1 year
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Mean FIM efficiency, calculated as [FIM gain]/ [rehabilitation length of stay (days)]
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Through study completion, an average of 1 year
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Mean Functional Independence Measure (FIM) effectiveness
時間枠:Within 72 hours
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Mean FIM effectiveness was calculated as FIM gain/(126 points-FIM admission scores) with a value of 0-1.
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Within 72 hours
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Body Mass Index (BMI)
時間枠:Within 72 hours
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All patients had their weight (in kilograms) and height (in meters) measured on admission and discharge by rehabilitation nurses 72 hours after rehabilitation admission and prior to planned rehabilitation discharge.
Weight was measured via sitting weighing scales or platform weighing scale for bedbound patients while height was measured with height measuring scale or measured in a supine position with legs outstretched and feet in dorsiflexion at end of bed for bedbound patients.
BMI is then calculated as weight /height in meters squared.
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Within 72 hours
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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。
スポンサー
捜査官
- 主任研究者:SZE CHIN JONG, MD、Tan Tock Seng Hospital
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 (実際)
2019年1月31日
一次修了 (実際)
2020年1月30日
研究の完了 (実際)
2020年7月30日
試験登録日
最初に提出
2020年10月30日
QC基準を満たした最初の提出物
2020年11月10日
最初の投稿 (実際)
2020年11月12日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月12日
QC基準を満たした最後の更新が送信されました
2020年11月10日
最終確認日
2020年11月1日
詳しくは
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。