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Life After STroke - the LAST Study (LAST)

2020년 4월 9일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

380

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 노르웨이
      • Sandvika, 노르웨이
        • Bærum Hospital
      • Trondheim, 노르웨이
        • St. Olavs Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 스탠다드 케어
행동: Standard care
Standard care as it is given to all stoke patients after stroke
실험적: Long term follow up program
행동: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Motor Assessment Scale
기간: 18 months after inclusion
A measure of over all motor function
18 months after inclusion

2차 결과 측정

결과 측정
측정값 설명
기간
Barthel Index
기간: 18 months follow up
A measure of activities of daily living
18 months follow up
Modified Rankin Scale
기간: 18 months follow up
A measure of dependency/independency
18 months follow up
Berg Balance Scale
기간: 18 months follow up
A measure of balance related to basic movement tasks
18 months follow up
Timed Up and Go
기간: 18 months follow up
A measure of balance related to transfer and walking
18 months follow up
Sit to stand test
기간: 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
기간: 18 months follow up
A measure of endurance
18 months follow up
Stroke Impact Scale
기간: 18 months follow up
A measure of health related quality of life after stroke
18 months follow up
EuroQol 5D
기간: 18 months follow up
A simple measure of health related quality of life for the general population
18 months follow up
Fatigue Severity Scale
기간: 18 months follow up
A measure of the presence of fatigue
18 months follow up
One simple question on fatigue from the HUNT3 questionnaire
기간: 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
기간: 18 months follow up
A measure of anxiety and depression
18 months follow up
Mini Mental State Examination
기간: 18 months follow up
A measure of cognitive function
18 months follow up
Montreal Cognitive Assessment
기간: 18 months follow up
A measure of cognitive function related to vascular dementia
18 months follow up
falls
기간: 6, 12 and 18 months
Serious falls will be recorded from the patients hospital records
6, 12 and 18 months
Readmission to hospital
기간: 6, 12 and 18 months
Number of readmissions to hospital will be recorded from the patients medical records
6, 12 and 18 months
Death
기간: 6, 12 and 18 months
Information about death will be collected from the Norwegain Death Registry
6, 12 and 18 months
Fractures
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 18 months
A simple measure of physical activity
18 months
Health costs
기간: 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
기간: 18 months follow up
A measure of stroke severity
18 months follow up
Modified Ashworth Scale
기간: 18 months follow up
A measure to rate the degree of spasticity after stroke
18 months follow up
Gait speed
기간: 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
기간: 18 months follow up
A simple measure of executive cognitive function
18 months follow up
DS-14
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
VO2-peak
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Norwegian University of Science and Technology

협력자

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

수사관

  • 연구 책임자: Bent Indredavik, Prof, National Taiwan Normal University
  • 수석 연구원: Torunn Askim, PhD, National Taiwan Normal University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2011년 11월 1일

기본 완료 (실제)

2015년 12월 1일

연구 완료 (실제)

2015년 12월 1일

연구 등록 날짜

최초 제출

2011년 10월 31일

QC 기준을 충족하는 최초 제출

2011년 11월 4일

처음 게시됨 (추정)

2011년 11월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 4월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 4월 9일

마지막으로 확인됨

2020년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 205309/H10

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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