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Life After STroke - the LAST Study (LAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01467206
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
St. Olavs Hospital
Asker & Baerum Hospital
The Research Council of Norway
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE October 31, 2011
First Posted Date  ICMJE November 8, 2011
Last Update Posted Date January 3, 2018
Actual Study Start Date  ICMJE November 2011
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2011)
Motor Assessment Scale [ Time Frame: 18 months after inclusion ]
A measure of over all motor function
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01467206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
  • Barthel Index [ Time Frame: 18 months follow up ]
    A measure of activities of daily living
  • Modified Rankin Scale [ Time Frame: 18 months follow up ]
    A measure of dependency/independency
  • Berg Balance Scale [ Time Frame: 18 months follow up ]
    A measure of balance related to basic movement tasks
  • Timed Up and Go [ Time Frame: 18 months follow up ]
    A measure of balance related to transfer and walking
  • Sit to stand test [ Time Frame: 18 months follow up ]
    A measure of dynamic muscle strength according to a sit to stand task
  • Six minute walk test [ Time Frame: 18 months follow up ]
    A measure of endurance
  • Stroke Impact Scale [ Time Frame: 18 months follow up ]
    A measure of health related quality of life after stroke
  • EuroQol 5D [ Time Frame: 18 months follow up ]
    A simple measure of health related quality of life for the general population
  • Fatigue Severity Scale [ Time Frame: 18 months follow up ]
    A measure of the presence of fatigue
  • One simple question on fatigue from the HUNT3 questionnaire [ Time Frame: 18 months follow up ]
    A simple question used to assess tiredness in teh general Norwegian population
  • Hospital Anxiety and Depression Scale [ Time Frame: 18 months follow up ]
    A measure of anxiety and depression
  • Mini Mental State Examination [ Time Frame: 18 months follow up ]
    A measure of cognitive function
  • Montreal Cognitive Assessment [ Time Frame: 18 months follow up ]
    A measure of cognitive function related to vascular dementia
  • falls [ Time Frame: 6, 12 and 18 months ]
    Serious falls will be recorded from the patients hospital records
  • Readmission to hospital [ Time Frame: 6, 12 and 18 months ]
    Number of readmissions to hospital will be recorded from the patients medical records
  • Death [ Time Frame: 6, 12 and 18 months ]
    Information about death will be collected from the Norwegain Death Registry
  • Fractures [ Time Frame: 6, 12 and 18 months ]
    Information about fractures during follow up will be collected from the patients medical records
  • Cardiovascular events [ Time Frame: 6, 12 and 18 months ]
    Information about any cardiovascular events will be collected from the patients medical record
  • Cerebrovascular events [ Time Frame: 6, 12 and 18 months ]
    Information about any cerebrovascular events during follow up will be collected from teh patient's medical records
  • International Physical Activity Questionnaire [ Time Frame: 6, 12 and 18 months ]
    A measure of physical activity over the last week
  • Physical activity assessed by ActivPAL sensor system [ Time Frame: 6, 12 and 18 months ]
    A sensor system to assess the amount of physical activity during a 4-7 day period
  • Three simple questions on physical activity from the HUNT questionnaire [ Time Frame: 18 months ]
    A simple measure of physical activity
  • Health costs [ Time Frame: 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.
  • National Institutes of Health Stroke Scale [ Time Frame: 18 months follow up ]
    A measure of stroke severity
  • Modified Ashworth Scale [ Time Frame: 18 months follow up ]
    A measure to rate the degree of spasticity after stroke
  • Gait speed [ Time Frame: 18 months follow up ]
    A simple measure of maximum gait speed across a 10 metres distance
  • Trailmaking test A and B [ Time Frame: 18 months follow up ]
    A simple measure of executive cognitive function
  • DS-14 [ Time Frame: 18 months follow up ]
    A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2011)
  • Barthel Index [ Time Frame: 18 months follow up ]
    A measure of activities of daily living
  • Modified Rankin Scale [ Time Frame: 18 months follow up ]
    A measure of dependency/independency
  • Berg Balance Scale [ Time Frame: 18 months follow up ]
    A measure of balance related to basic movement tasks
  • Timed Up and Go [ Time Frame: 18 months follow up ]
    A measure of balance related to transfer and walking
  • Sit to stand test [ Time Frame: 18 months follow up ]
    A measure of dynamic muscle strength according to a sit to stand task
  • Six minute walk test [ Time Frame: 18 months follow up ]
    A measure of endurance
  • Stroke Impact Scale [ Time Frame: 18 months follow up ]
    A measure of health related quality of life after stroke
  • EuroQol 5D [ Time Frame: 18 months follow up ]
    A simple measure of health related quality of life for the general population
  • Fatigue Severity Scale [ Time Frame: 18 months follow up ]
    A measure of the presence of fatigue
  • One simple question on fatigue from the HUNT3 questionnaire [ Time Frame: 18 months follow up ]
    A simple question used to assess tiredness in teh general Norwegian population
  • Hospital Anxiety and Depression Scale [ Time Frame: 18 months follow up ]
    A measure of anxiety and depression
  • Mini Mental State Examination [ Time Frame: 18 months follow up ]
    A measure of cognitive function
  • Montreal Cognitive Assessment [ Time Frame: 18 months follow up ]
    A measure of cognitive function related to vascular dementia
  • falls [ Time Frame: 6, 12 and 18 months ]
    Serious falls will be recorded from the patients hospital records
  • Readmission to hospital [ Time Frame: 6, 12 and 18 months ]
    Number of readmissions to hospital will be recorded from the patients medical records
  • Death [ Time Frame: 6, 12 and 18 months ]
    Information about death will be collected from the Norwegain Death Registry
  • Fractures [ Time Frame: 6, 12 and 18 months ]
    Information about fractures during follow up will be collected from the patients medical records
  • Cardiovascular events [ Time Frame: 6, 12 and 18 months ]
    Information about any cardiovacular events will be collected from the patients medical record
  • Cerebrovascular events [ Time Frame: 6, 12 and 18 months ]
    Information about any cerebrovascular events during follow up will be collected from teh patient's medical records
  • International Physical Activity Questionnaire [ Time Frame: Every sixth month ]
    A measure of physical activity over the last week
  • Physical activity assessed by ActivPAL sensor system [ Time Frame: 6, 12 and 18 months ]
    A sensor system to assess the amount of physical activity during a 4-7 day period
  • Three simple questions on physical activity from the HUNT questionnaire [ Time Frame: 18 months ]
    A simple measure of physical activity
  • Health costs [ Time Frame: 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.
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2013)
VO2-peak [ Time Frame: 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Life After STroke - the LAST Study
Official Title  ICMJE Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebral Infarction
  • Cerebral Hemorrhage
Intervention  ICMJE
  • Behavioral: 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
  • Behavioral: Standard care
    Standard care as it is given to all stoke patients after stroke
Study Arms  ICMJE
  • Experimental: Long term follow up program
    Intervention: Behavioral: Long term follow up by a coordinating physiotherapist
  • Active Comparator: Standard care
    Intervention: Behavioral: Standard care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2016)
380
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2011)
390
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01467206
Other Study ID Numbers  ICMJE 205309/H10
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • St. Olavs Hospital
  • Asker & Baerum Hospital
  • The Research Council of Norway
  • Helse Midt-Norge
Investigators  ICMJE
Study Director: Bent Indredavik, Prof National Taiwan Normal University
Principal Investigator: Torunn Askim, PhD National Taiwan Normal University
PRS Account Norwegian University of Science and Technology
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP