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Life After STroke - the LAST Study (LAST)

2020年4月9日 更新者：Norwegian University of Science and Technology

Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial

The LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every week and 30 minutes of physical activity every day for 18 months after inclusion. The primary hypothesis is that patients receiving a long term follow up program after stroke will have better motor function at end of follow up than patients receiving standard care. A total of 390 home dwelling stroke patients living in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will be randomised to an intervention group receiving the long term follow up program or to a control group receiving standard care. Motor function, mental health and physical functioning in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by the Norwegian Research Council, the Norwegian University of Science and Technology and the Central Norway Regional Health Authority and will conclude at the end of 2015.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Supplement to the Life After Stroke - the LAST study ClinicalTrials.gov ID: NCT01467206

Changes in the planned statistical analysis, November 9, 2015 The original plan for statistical analysis was published in; Askim T, Langhammer B, Ihle-Hansen H, Magnussen J, Engstad T, Indredavik B. A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke-The LAST Study. Stroke Res Treat. 2012;2012:392101. doi: 10.1155/2012/392101. Epub 2012 Nov 22.

Original plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Mann-Whitney U test will be used for secondary data not being normal distributed. In all analyses we will control for potential confounding factors, investigate effect modifications, and present both unadjusted and adjusted effects with 95% confidence intervals.

Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site) to explore trends within subgroups of patients.

Revised plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Similar ANCOVA analyses will be used for the relevant secondary endpoints. Mann-Whitney U test will be used for secondary data not being normal distributed.

Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site), gender, and cognitive status (Mini Mental State below 25), to explore trends within subgroups of patients.

Missing values will be handled using single imputation (typically for items on instrument scales), or by multiple imputation, as appropriate.

研究の種類

介入

入学 (実際)

380

段階

  • 適用できない

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

  • ノルウェー
      • Sandvika、ノルウェー
        • Bærum Hospital
      • Trondheim、ノルウェー
        • St. Olavs Hospital

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～95年 (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

説明

Inclusion Criteria:

  • Diagnosis of stroke according to WHO's definition of stroke
  • Living in the city of Trondheim or the municipalities of Asker or Bærum
  • Included 2.5 - 4 months after stroke
  • Modified Rankin Scale 0 - 4
  • Living at home
  • Mini Mental State Examination > 20 or > 16 if aphasia
  • Provide informed consent

Exclusion Criteria:

  • Are already included in the study
  • Are included in other experimental studies
  • Unstable coronary function
  • Uncompensated heartfailure
  • Other diseases that make it difficult to complete the intervention

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

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：標準ケア
行動：Standard care
Standard care as it is given to all stoke patients after stroke
実験的：Long term follow up program
行動：Long term follow up by a coordinating physiotherapist
Monthly meetings with an coordinating physiotherapist who motivate and encourage the patient to do 60 minutes of weekly exercise and 30 minutes of daily physical activity

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
Motor Assessment Scale
時間枠：18 months after inclusion
A measure of over all motor function
18 months after inclusion

二次結果の測定

結果測定
メジャーの説明
時間枠
Barthel Index
時間枠：18 months follow up
A measure of activities of daily living
18 months follow up
Modified Rankin Scale
時間枠：18 months follow up
A measure of dependency/independency
18 months follow up
Berg Balance Scale
時間枠：18 months follow up
A measure of balance related to basic movement tasks
18 months follow up
Timed Up and Go
時間枠：18 months follow up
A measure of balance related to transfer and walking
18 months follow up
Sit to stand test
時間枠：18 months follow up
A measure of dynamic muscle strength according to a sit to stand task
18 months follow up
Six minute walk test
時間枠：18 months follow up
A measure of endurance
18 months follow up
Stroke Impact Scale
時間枠：18 months follow up
A measure of health related quality of life after stroke
18 months follow up
EuroQol 5D
時間枠：18 months follow up
A simple measure of health related quality of life for the general population
18 months follow up
Fatigue Severity Scale
時間枠：18 months follow up
A measure of the presence of fatigue
18 months follow up
One simple question on fatigue from the HUNT3 questionnaire
時間枠：18 months follow up
A simple question used to assess tiredness in teh general Norwegian population
18 months follow up
Hospital Anxiety and Depression Scale
時間枠：18 months follow up
A measure of anxiety and depression
18 months follow up
Mini Mental State Examination
時間枠：18 months follow up
A measure of cognitive function
18 months follow up
Montreal Cognitive Assessment
時間枠：18 months follow up
A measure of cognitive function related to vascular dementia
18 months follow up
falls
時間枠：6, 12 and 18 months
Serious falls will be recorded from the patients hospital records
6, 12 and 18 months
Readmission to hospital
時間枠：6, 12 and 18 months
Number of readmissions to hospital will be recorded from the patients medical records
6, 12 and 18 months
Death
時間枠：6, 12 and 18 months
Information about death will be collected from the Norwegain Death Registry
6, 12 and 18 months
Fractures
時間枠：6, 12 and 18 months
Information about fractures during follow up will be collected from the patients medical records
6, 12 and 18 months
Cardiovascular events
時間枠：6, 12 and 18 months
Information about any cardiovascular events will be collected from the patients medical record
6, 12 and 18 months
Cerebrovascular events
時間枠：6, 12 and 18 months
Information about any cerebrovascular events during follow up will be collected from teh patient's medical records
6, 12 and 18 months
International Physical Activity Questionnaire
時間枠：6, 12 and 18 months
A measure of physical activity over the last week
6, 12 and 18 months
Physical activity assessed by ActivPAL sensor system
時間枠：6, 12 and 18 months
A sensor system to assess the amount of physical activity during a 4-7 day period
6, 12 and 18 months
Three simple questions on physical activity from the HUNT questionnaire
時間枠：18 months
A simple measure of physical activity
18 months
Health costs
時間枠：6, 12 and 18 months
Information about the use of health services will be collected by reviewing the patients' hospital records and records in primary health care system.
6, 12 and 18 months
National Institutes of Health Stroke Scale
時間枠：18 months follow up
A measure of stroke severity
18 months follow up
Modified Ashworth Scale
時間枠：18 months follow up
A measure to rate the degree of spasticity after stroke
18 months follow up
Gait speed
時間枠：18 months follow up
A simple measure of maximum gait speed across a 10 metres distance
18 months follow up
Trailmaking test A and B
時間枠：18 months follow up
A simple measure of executive cognitive function
18 months follow up
DS-14
時間枠：18 months follow up
A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis.
18 months follow up

その他の成果指標

結果測定
メジャーの説明
時間枠
VO2-peak
時間枠：18 months follow up

VO2-peak is obtained by use of a symptom limited treadmill test to measure cardiovascular fitness.

This measure is only used in the Trondheim arm of the study
18 months follow up

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

Norwegian University of Science and Technology

協力者

The Research Council of Norway
Asker & Baerum Hospital
St. Olavs Hospital
Helse Midt-Norge

捜査官

  • スタディディレクター：Bent Indredavik, Prof、National Taiwan Normal University
  • 主任研究者：Torunn Askim, PhD、National Taiwan Normal University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2011年11月1日

一次修了 (実際)

2015年12月1日

研究の完了 (実際)

2015年12月1日

試験登録日

最初に提出

2011年10月31日

QC基準を満たした最初の提出物

2011年11月4日

最初の投稿 (見積もり)

2011年11月8日

学習記録の更新

投稿された最後の更新 (実際)

2020年4月13日

QC基準を満たした最後の更新が送信されました

2020年4月9日

最終確認日

2020年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 205309/H10

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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