Physical Activity Immediately After Acute Cerebral Ischemia

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Physical activity 15 minutes/day Behavioral
    Intervention Desc: weight-bearing treadmill, pulsereserve increase of 50 %
    ARM 1: Kind: Experimental
    Label: Low Dose Training
    Description: 15 minutes/day on a weight-bearing treadmill
  • Physical activity, 2 x 30 minutes/day Behavioral
    Intervention Desc: weight-bearing treadmill, pulsereserve increase of 50 %
    ARM 1: Kind: Experimental
    Label: High Dose Training
    Description: 2x 30 minutes/day on a weight-bearing treadmill

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary disability up to 5 days No
Secondary inflammation level up to 5 days No
Secondary activity counts per day up to 5 days No
Primary change in disability from baseline up to 5 days No
Secondary change in inflammation level from baseline up to 5 days No
Secondary changes and level of activity during up to 5 days of hospitalization up to 5 days No
Secondary number of complications per patient up to 30 days No

Sponsors