Physical Activity Immediately After Acute Cerebral Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01560520
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : October 18, 2012
Information provided by (Responsible Party):
Anna Maria Strømmen, Hillerod Hospital, Denmark

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 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 describe the amount and pattern of physical activity in stroke patients in the first week after admission. The investigators hypothesis is that patients are inactive for most of the time during hospitalization, activity being correlated with severity of stroke, but not with age, BMI and sex.

Condition or disease Intervention/treatment
Ischemic Stroke Physical Activity Behavioral: Physical activity

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much?
Study Start Date : November 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Accelerometer Behavioral: Physical activity
Observation only
Other Name: actical, Actical

Primary Outcome Measures :
  1. activity counts per day [ Time Frame: up to 7 days ]

Secondary Outcome Measures :
  1. Inflammation level [ Time Frame: up to 7 days ]
    biomarker concentration

  2. Disability [ Time Frame: up to 7 days ]
    Scandinavian Stroke Scale score (SSS), National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale score (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS)

Biospecimen Retention:   Samples Without DNA
Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with stroke admitted acutely to a hospital

Inclusion Criteria:

  • patients admitted with acute ischemic stroke
  • age > 18 years

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
  • bloodsampling generally not possible
  • allergy due to accelerometer wear
  • ulcers or other skin diseases in the area of accelerometer placement

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 identifier (NCT number): NCT01560520

Hillerød Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Principal Investigator: Anna Maria Strømmen, MD Neurologic Department

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anna Maria Strømmen, clinical assistant, Hillerod Hospital, Denmark Identifier: NCT01560520     History of Changes
Other Study ID Numbers: 30704
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012

Keywords provided by Anna Maria Strømmen, Hillerod Hospital, Denmark:
acute ischemic stroke

Additional relevant MeSH terms:
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction