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Life After STroke - the LAST Study (LAST)

9. april 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

380

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 95 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard pleje
Adfærdsmæssigt: Standard care
Standard care as it is given to all stoke patients after stroke
Eksperimentel: Long term follow up program
Adfærdsmæssigt: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Motor Assessment Scale
Tidsramme: 18 months after inclusion
A measure of over all motor function
18 months after inclusion

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
VO2-peak
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norwegian University of Science and Technology

Samarbejdspartnere

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

Efterforskere

  • Studieleder: Bent Indredavik, Prof, National Taiwan Normal University
  • Ledende efterforsker: Torunn Askim, PhD, National Taiwan Normal University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2011

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

31. oktober 2011

Først indsendt, der opfyldte QC-kriterier

4. november 2011

Først opslået (Skøn)

8. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 205309/H10

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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