Physical Activity Immediately After Acute Cerebral Ischemia 3
1 other identifier
interventional
20
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 feasibility of treadmill training on a weight-bearing treadmill in the acute phase after admission after an ischemic stroke. Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and whether it changes with treadmill training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Shorter than P25 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
October 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMarch 14, 2013
March 1, 2013
5 months
October 17, 2012
March 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of inflammation, under, during and after treadmill training
Biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Necrosis Factor(TNF)-alpha, C-Reactive Protein (CRP), IL-1ra, IL-10, fasting-insulin, fasting-glucose
up to 5 days
Secondary Outcomes (2)
Correlation of biomarker level
up to 5 days
Feasibility
up to 5 days
Study Arms (1)
High dose training
EXPERIMENTAL2 x 30 minutes/day on a weight-bearing treadmill
Interventions
weight-bearing treadmill, pulse reserve 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 score for arm and leg: 10 out of 12 points
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
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical assistant
Study Record Dates
First Submitted
October 17, 2012
First Posted
October 23, 2012
Study Start
December 1, 2012
Primary Completion
May 1, 2013
Study Completion
August 1, 2013
Last Updated
March 14, 2013
Record last verified: 2013-03