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Physical Activity Immediately After Acute Cerebral Ischemia 3

Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01712282
Enrollment
20
Registered
2012-10-23
Start date
2012-12-31
Completion date
2013-08-31
Last updated
2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Physical Activity, Accelerometer

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.

Interventions

weight-bearing treadmill, pulse reserve increase of 50%

Sponsors

Hillerod Hospital, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 score for arm and leg: 10 out of 12 points

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.)

Design outcomes

Primary

MeasureTime frameDescription
Level of inflammation, under, during and after treadmill trainingup to 5 daysBiomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Necrosis Factor(TNF)-alpha, C-Reactive Protein (CRP), IL-1ra, IL-10, fasting-insulin, fasting-glucose

Secondary

MeasureTime frameDescription
Correlation of biomarker levelup to 5 daysCorrelation with time, activity counts on an accelerometer, Scandinavian Stroke Scale Score (SSS), 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), Bergs Balance test, age, Body Mass Index and sex
Feasibilityup to 5 daysWhether it is feasible/possible to train patients on a treadmill in the acute phase after ischemic stroke; eg. whether patients are too exhausted to train twice daily, experience complications during training such as nausea or dizziness and therefore can't complete the training programme.

Countries

Denmark

Contacts

Primary ContactAnna M Strømmen, MD
anna.maria.stroemmen@regionh.dk+4548297353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026