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Physical Activity Immediately After Acute Cerebral Ischemia

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ClinicalTrials.gov Identifier: NCT01594190
Recruitment Status : Unknown
Verified May 2012 by Anna Maria Strømmen, Hillerod Hospital, Denmark.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2012
Last Update Posted : May 9, 2012
Sponsor:
Information provided by (Responsible Party):
Anna Maria Strømmen, Hillerod Hospital, Denmark

Study Description
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Brief Summary:

Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.

Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.

Accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.

Another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.

Clarification of the optimal dose of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.

The purpose of the project is to investigate which dose (15 vs. 2 x 30 minutes) of physical activity on a weight-bearing treadmill in the first 5 days after admission after an ischemic stroke, gives patients the best improvement in neurological dysfunction.


Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Physical Activity Accelerometer Behavioral: physical activity 15 minutes/day Behavioral: physical activity, 2 x 30 minutes/day Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much - a Randomized Controlled Study
Study Start Date : September 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : September 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Low Dose Training
15 minutes/day on a weight-bearing treadmill
 Behavioral: physical activity 15 minutes/day
weight-bearing treadmill, pulsereserve increase of 50 %
Active Comparator: High Dose Training
2x 30 minutes/day on a weight-bearing treadmill
 Behavioral: physical activity, 2 x 30 minutes/day
weight-bearing treadmill, pulsereserve increase of 50 %


Outcome Measures
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Primary Outcome Measures :
  1. change in disability from baseline [ Time Frame: up to 5 days ]
    Scandinavian Stroke Scale (SSS)


Secondary Outcome Measures :
  1. change in inflammation level from baseline [ Time Frame: up to 5 days ]
    biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose

  2. change in disability from baseline [ Time Frame: up to 5 days ]
    National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS), Assessment of Motor and Process Skills (AMPS)

  3. changes and level of activity during up to 5 days of hospitalization [ Time Frame: up to 5 days ]
    activity counts per day measured by an accelerometer

  4. number of complications per patient [ Time Frame: up to 30 days ]
    all complications are counted from inclusion till day 30 in all patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients admitted with acute ischemic stroke
  • age > 18 years
  • first stroke or only minor invalidity from previous strokes (mRS 0-2)
  • truncal stability
  • SSS < 58

Exclusion Criteria:

  • symptoms attributable to other diseases than ischemic stroke
  • debut of symptoms > 48 h prior to admission
  • consent not given < 24 h of admission
  • pregnancy or lactation
  • isolation
  • blood sampling generally not possible
  • allergy due to accelerometer wear
  • ulcers or other skin diseases in the area of accelerometer placement
  • unstable cardiologic condition (AMI etc.)
  • acute high and sustained resting systolic blood pressure where treatment is necessary
  • acute heart rhythm disorder where treatment is necessary
  • unable to cooperate
  • significant orthopedic conditions (fractures etc.)
Contacts and Locations
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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): NCT01594190


Contacts
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Contact: Anna Maria Strømmen, MD +4548297353 amic@noh.regionh.dk

Locations
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Denmark
Hillerød Hospital
Hillerød, Denmark, 3400
Contact: Anna Maria Strømmen, MD    +4548297353    amic@noh.regionh.dk   
Principal Investigator: Anna Maria Strømmen, MD         
Sponsors and Collaborators
Hillerod Hospital, Denmark
More Information
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Responsible Party: Anna Maria Strømmen, clinical assistant, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01594190    
Other Study ID Numbers: 30704 part 2
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Brain Ischemia
Cerebral Infarction
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke