Physical Activity Immediately After Acute Cerebral Ischemia
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 9, 2012
May 1, 2012
1.8 years
November 2, 2011
May 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
change in disability from baseline
Scandinavian Stroke Scale (SSS)
up to 5 days
Secondary Outcomes (4)
change in inflammation level from baseline
up to 5 days
change in disability from baseline
up to 5 days
changes and level of activity during up to 5 days of hospitalization
up to 5 days
number of complications per patient
up to 30 days
Study Arms (2)
Low Dose Training
ACTIVE COMPARATOR15 minutes/day on a weight-bearing treadmill
High Dose Training
ACTIVE COMPARATOR2x 30 minutes/day on a weight-bearing treadmill
Interventions
weight-bearing treadmill, pulsereserve increase of 50 %
weight-bearing treadmill, pulsereserve increase of 50 %
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillerød Hospital
Hillerød, 3400, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical assistant
Study Record Dates
First Submitted
November 2, 2011
First Posted
May 8, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2014
Study Completion
September 1, 2014
Last Updated
May 9, 2012
Record last verified: 2012-05