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Life After STroke - the LAST Study (LAST)

9. april 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

380

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 95 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Standard omsorg
Atferdsmessig: Standard care
Standard care as it is given to all stoke patients after stroke
Eksperimentell: Long term follow up program
Atferdsmessig: 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

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Norwegian University of Science and Technology

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2011

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

31. oktober 2011

Først innsendt som oppfylte QC-kriteriene

4. november 2011

Først lagt ut (Anslag)

8. november 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. april 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 205309/H10

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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