Physical Activity Immediately After Acute Cerebral Ischemia
Primary Purpose
Acute Ischemic Stroke, Physical Activity, Accelerometer
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
physical activity 15 minutes/day
physical activity, 2 x 30 minutes/day
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility 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.)
Sites / Locations
- Hillerød Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low Dose Training
High Dose Training
Arm Description
15 minutes/day on a weight-bearing treadmill
2x 30 minutes/day on a weight-bearing treadmill
Outcomes
Primary Outcome Measures
change in disability from baseline
Scandinavian Stroke Scale (SSS)
Secondary Outcome Measures
change in inflammation level from baseline
biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose
change in disability from baseline
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)
changes and level of activity during up to 5 days of hospitalization
activity counts per day measured by an accelerometer
number of complications per patient
all complications are counted from inclusion till day 30 in all patients
Full Information
NCT ID
NCT01594190
First Posted
November 2, 2011
Last Updated
May 8, 2012
Sponsor
Hillerod Hospital, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01594190
Brief Title
Physical Activity Immediately After Acute Cerebral Ischemia
Official Title
Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much - a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hillerod Hospital, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke, Physical Activity, Accelerometer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Dose Training
Arm Type
Active Comparator
Arm Description
15 minutes/day on a weight-bearing treadmill
Arm Title
High Dose Training
Arm Type
Active Comparator
Arm Description
2x 30 minutes/day on a weight-bearing treadmill
Intervention Type
Behavioral
Intervention Name(s)
physical activity 15 minutes/day
Intervention Description
weight-bearing treadmill, pulsereserve increase of 50 %
Intervention Type
Behavioral
Intervention Name(s)
physical activity, 2 x 30 minutes/day
Intervention Description
weight-bearing treadmill, pulsereserve increase of 50 %
Primary Outcome Measure Information:
Title
change in disability from baseline
Description
Scandinavian Stroke Scale (SSS)
Time Frame
up to 5 days
Secondary Outcome Measure Information:
Title
change in inflammation level from baseline
Description
biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose
Time Frame
up to 5 days
Title
change in disability from baseline
Description
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)
Time Frame
up to 5 days
Title
changes and level of activity during up to 5 days of hospitalization
Description
activity counts per day measured by an accelerometer
Time Frame
up to 5 days
Title
number of complications per patient
Description
all complications are counted from inclusion till day 30 in all patients
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Maria Strømmen, MD
Phone
+4548297353
Email
amic@noh.regionh.dk
Facility Information:
Facility Name
Hillerød Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Maria Strømmen, MD
Phone
+4548297353
Email
amic@noh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Anna Maria Strømmen, MD
12. IPD Sharing Statement
Learn more about this trial
Physical Activity Immediately After Acute Cerebral Ischemia
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