Life After STroke - the LAST Study (LAST)

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Infarction; Cerebral Hemorrhage
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care	Behavioral: Standard care; Standard care as it is given to all stoke patients after stroke
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Assessment Scale	A measure of over all motor function	18 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index	A measure of activities of daily living	18 months follow up
Modified Rankin Scale	A measure of dependency/independency	18 months follow up
Berg Balance Scale	A measure of balance related to basic movement tasks	18 months follow up
Timed Up and Go	A measure of balance related to transfer and walking	18 months follow up
Sit to stand test	A measure of dynamic muscle strength according to a sit to stand task	18 months follow up
Six minute walk test	A measure of endurance	18 months follow up
Stroke Impact Scale	A measure of health related quality of life after stroke	18 months follow up
EuroQol 5D	A simple measure of health related quality of life for the general population	18 months follow up
Fatigue Severity Scale	A measure of the presence of fatigue	18 months follow up
One simple question on fatigue from the HUNT3 questionnaire	A simple question used to assess tiredness in teh general Norwegian population	18 months follow up
Hospital Anxiety and Depression Scale	A measure of anxiety and depression	18 months follow up
Mini Mental State Examination	A measure of cognitive function	18 months follow up
Montreal Cognitive Assessment	A measure of cognitive function related to vascular dementia	18 months follow up
falls	Serious falls will be recorded from the patients hospital records	6, 12 and 18 months
Readmission to hospital	Number of readmissions to hospital will be recorded from the patients medical records	6, 12 and 18 months
Death	Information about death will be collected from the Norwegain Death Registry	6, 12 and 18 months
Fractures	Information about fractures during follow up will be collected from the patients medical records	6, 12 and 18 months
Cardiovascular events	Information about any cardiovascular events will be collected from the patients medical record	6, 12 and 18 months
Cerebrovascular events	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	A measure of physical activity over the last week	6, 12 and 18 months
Physical activity assessed by ActivPAL sensor system	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	A simple measure of physical activity	18 months
Health costs	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	A measure of stroke severity	18 months follow up
Modified Ashworth Scale	A measure to rate the degree of spasticity after stroke	18 months follow up
Gait speed	A simple measure of maximum gait speed across a 10 metres distance	18 months follow up
Trailmaking test A and B	A simple measure of executive cognitive function	18 months follow up
DS-14	A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis.	18 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2-peak	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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: The Research Council of Norway; Asker & Baerum Hospital; St. Olavs Hospital; Helse Midt-Norge
• Investigators: Study Director: Bent Indredavik, Prof, National Taiwan Normal University; Principal Investigator: Torunn Askim, PhD, National Taiwan Normal University

Publications and helpful links

General Publications

• 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.
• Askim T, Langhammer B, Ihle-Hansen H, Gunnes M, Lydersen S, Indredavik B; LAST Collaboration Group. Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial. Stroke. 2018 Feb;49(2):426-432. doi: 10.1161/STROKEAHA.117.018827. Epub 2017 Dec 28.
• Dohl O, Halsteinli V, Askim T, Gunnes M, Ihle-Hansen H, Indredavik B, Langhammer B, Phan A, Magnussen J. Factors contributing to post-stroke health care utilization and costs, secondary results from the life after stroke (LAST) study. BMC Health Serv Res. 2020 Apr 6;20(1):288. doi: 10.1186/s12913-020-05158-w.
• Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6:CD012996. doi: 10.1002/14651858.CD012996.pub2.
• Gunnes M, Indredavik B, Langhammer B, Lydersen S, Ihle-Hansen H, Dahl AE, Askim T; LAST Collaboration group. Associations Between Adherence to the Physical Activity and Exercise Program Applied in the LAST Study and Functional Recovery After Stroke. Arch Phys Med Rehabil. 2019 Dec;100(12):2251-2259. doi: 10.1016/j.apmr.2019.04.023. Epub 2019 Jul 30.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 4, 2011
• First Posted (Estimate): November 8, 2011

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Physiotherapy; Motor training
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Intracranial Hemorrhages; Infarction; Hemorrhage; Cerebral Infarction; Cerebral Hemorrhage
• Other Study ID Numbers: 205309/H10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No