Life After STroke - the LAST Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Norwegian University of Science and Technology
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
ClinicalTrials.gov Identifier:
NCT01467206
First received: October 31, 2011
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 Intervention
Cerebral Infarction
Cerebral Hemorrhage
Behavioral: Long term follow up by a coordinating physiotherapist
Behavioral: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Motor Assessment Scale [ Time Frame: 18 months after inclusion ] [ Designated as safety issue: No ]
    A measure of over all motor function


Secondary Outcome Measures:
  • Barthel Index [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of activities of daily living

  • Modified Rankin Scale [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of dependency/independency

  • Berg Balance Scale [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of balance related to basic movement tasks

  • Timed Up and Go [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of balance related to transfer and walking

  • Sit to stand test [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of dynamic muscle strength according to a sit to stand task

  • Six minute walk test [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of endurance

  • Stroke Impact Scale [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of health related quality of life after stroke

  • EuroQol 5D [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A simple measure of health related quality of life for the general population

  • Fatigue Severity Scale [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of the presence of fatigue

  • One simple question on fatigue from the HUNT3 questionnaire [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A simple question used to assess tiredness in teh general Norwegian population

  • Hospital Anxiety and Depression Scale [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of anxiety and depression

  • Mini Mental State Examination [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of cognitive function

  • Montreal Cognitive Assessment [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure of cognitive function related to vascular dementia

  • falls [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Serious falls will be recorded from the patients hospital records

  • Readmission to hospital [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Number of readmissions to hospital will be recorded from the patients medical records

  • Death [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Information about death will be collected from the Norwegain Death Registry

  • Fractures [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Information about fractures during follow up will be collected from the patients medical records

  • Cardiovascular events [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Information about any cardiovascular events will be collected from the patients medical record

  • Cerebrovascular events [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A measure of physical activity over the last week

  • Physical activity assessed by ActivPAL sensor system [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A simple measure of physical activity

  • Health costs [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A measure of stroke severity

  • Modified Ashworth Scale [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A measure to rate the degree of spasticity after stroke

  • Gait speed [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A simple measure of maximum gait speed across a 10 metres distance

  • Trailmaking test A and B [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A simple measure of executive cognitive function

  • DS-14 [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]
    A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis.


Other Outcome Measures:
  • VO2-peak [ Time Frame: 18 months follow up ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 390
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467206

Contacts
Contact: Torunn Askim, PhD +4799589235 torunn.askim@ntnu.no

Locations
Norway
Bærum Hospital Recruiting
Bærum, Norway
Contact: Birgitta Langhammer, PhD    +47 22 45 25 10    birgitta.langhammer@hioa.no   
St. Olavs Hospital Recruiting
Trondheim, Norway
Contact: Torunn Askim, PhD    +4799589235    torunn.askim@ntnu.no   
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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01467206     History of Changes
Other Study ID Numbers: 205309/H10
Study First Received: October 31, 2011
Last Updated: May 7, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on October 20, 2014