NCT01467206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

4.1 years

First QC Date

October 31, 2011

Last Update Submit

April 9, 2020

Conditions

Cerebral InfarctionCerebral Hemorrhage

Keywords

StrokePhysiotherapyMotor trainingRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Motor Assessment Scale

    A measure of over all motor function

    18 months after inclusion

Secondary Outcomes (28)

  • Barthel Index

    18 months follow up

  • Modified Rankin Scale

    18 months follow up

  • Berg Balance Scale

    18 months follow up

  • Timed Up and Go

    18 months follow up

  • Sit to stand test

    18 months follow up

  • +23 more secondary outcomes

Other Outcomes (1)

  • VO2-peak

    18 months follow up

Study Arms (2)

Long term follow up program

EXPERIMENTAL
Behavioral: Long term follow up by a coordinating physiotherapist

Standard care

ACTIVE COMPARATOR
Behavioral: Standard care

Interventions

Long term follow up by a coordinating physiotherapistBEHAVIORAL

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

Long term follow up program
Standard careBEHAVIORAL

Standard care as it is given to all stoke patients after stroke

Standard care

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bærum Hospital

Sandvika, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Related Publications (5)

  • 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.

    PMID: 23227428BACKGROUND

  • 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.

    PMID: 29284737RESULT

  • 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.

    PMID: 32252739RESULT

  • 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(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

    PMID: 34184251DERIVED

  • 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.

    PMID: 31374191DERIVED

MeSH Terms

Conditions

Cerebral InfarctionCerebral HemorrhageStroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisIntracranial HemorrhagesHemorrhage

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Bent Indredavik, Prof

    National Taiwan Normal University

    STUDY DIRECTOR

  • Torunn Askim, PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 8, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations

NO(2)