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Life After STroke - the LAST Study (LAST)

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ClinicalTrials.gov Identifier: NCT01467206
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cerebral Infarction Cerebral Hemorrhage Behavioral: Long term follow up by a coordinating physiotherapist Behavioral: Standard care

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
Actual Study Start Date : November 2011
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Long term follow up program 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
Active Comparator: Standard care Behavioral: Standard care
Standard care as it is given to all stoke patients after stroke


Outcome Measures

Primary Outcome Measures :
  1. Motor Assessment Scale [ Time Frame: 18 months after inclusion ]
    A measure of over all motor function


Secondary Outcome Measures :
  1. Barthel Index [ Time Frame: 18 months follow up ]
    A measure of activities of daily living

  2. Modified Rankin Scale [ Time Frame: 18 months follow up ]
    A measure of dependency/independency

  3. Berg Balance Scale [ Time Frame: 18 months follow up ]
    A measure of balance related to basic movement tasks

  4. Timed Up and Go [ Time Frame: 18 months follow up ]
    A measure of balance related to transfer and walking

  5. Sit to stand test [ Time Frame: 18 months follow up ]
    A measure of dynamic muscle strength according to a sit to stand task

  6. Six minute walk test [ Time Frame: 18 months follow up ]
    A measure of endurance

  7. Stroke Impact Scale [ Time Frame: 18 months follow up ]
    A measure of health related quality of life after stroke

  8. EuroQol 5D [ Time Frame: 18 months follow up ]
    A simple measure of health related quality of life for the general population

  9. Fatigue Severity Scale [ Time Frame: 18 months follow up ]
    A measure of the presence of fatigue

  10. 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

  11. Hospital Anxiety and Depression Scale [ Time Frame: 18 months follow up ]
    A measure of anxiety and depression

  12. Mini Mental State Examination [ Time Frame: 18 months follow up ]
    A measure of cognitive function

  13. Montreal Cognitive Assessment [ Time Frame: 18 months follow up ]
    A measure of cognitive function related to vascular dementia

  14. falls [ Time Frame: 6, 12 and 18 months ]
    Serious falls will be recorded from the patients hospital records

  15. Readmission to hospital [ Time Frame: 6, 12 and 18 months ]
    Number of readmissions to hospital will be recorded from the patients medical records

  16. Death [ Time Frame: 6, 12 and 18 months ]
    Information about death will be collected from the Norwegain Death Registry

  17. Fractures [ Time Frame: 6, 12 and 18 months ]
    Information about fractures during follow up will be collected from the patients medical records

  18. Cardiovascular events [ Time Frame: 6, 12 and 18 months ]
    Information about any cardiovascular events will be collected from the patients medical record

  19. 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

  20. International Physical Activity Questionnaire [ Time Frame: 6, 12 and 18 months ]
    A measure of physical activity over the last week

  21. 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

  22. Three simple questions on physical activity from the HUNT questionnaire [ Time Frame: 18 months ]
    A simple measure of physical activity

  23. 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.

  24. National Institutes of Health Stroke Scale [ Time Frame: 18 months follow up ]
    A measure of stroke severity

  25. Modified Ashworth Scale [ Time Frame: 18 months follow up ]
    A measure to rate the degree of spasticity after stroke

  26. Gait speed [ Time Frame: 18 months follow up ]
    A simple measure of maximum gait speed across a 10 metres distance

  27. Trailmaking test A and B [ Time Frame: 18 months follow up ]
    A simple measure of executive cognitive function

  28. 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.


Other Outcome Measures:
  1. 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



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467206


Locations
Norway
Bærum Hospital
Sandvika, Norway
St. Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Asker & Baerum Hospital
The Research Council of Norway
Helse Midt-Norge
Investigators
Study Director: Bent Indredavik, Prof NTNU
Principal Investigator: Torunn Askim, PhD NTNU
More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01467206     History of Changes
Other Study ID Numbers: 205309/H10
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Stroke
Physiotherapy
Motor training
Rehabilitation

Additional relevant MeSH terms:
Infarction
Hemorrhage
Cerebral Infarction
Cerebral Hemorrhage
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages