Physical Activity Immediately After Acute Cerebral Ischemia

Physical Activity Clinical Trial

Official title:

Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much - a Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01594190
• Other study ID #: 30704 part 2
• Status: Not yet recruiting
• Phase: N/A
• First received: November 2, 2011
• Last updated: May 8, 2012
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2012
• Source: Hillerod Hospital, Denmark
• Contact: Anna Maria Strømmen, MD
• Phone: +4548297353
• Email: amic[@]noh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

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

Related Conditions & MeSH terms

• Accelerometer
• Acute Ischemic Stroke
• Cerebral Infarction
• Physical Activity

Intervention

Behavioral:
• physical activity 15 minutes/day
weight-bearing treadmill, pulsereserve increase of 50 %
• physical activity, 2 x 30 minutes/day
weight-bearing treadmill, pulsereserve increase of 50 %

Locations

Country	Name	City	State
Denmark	Hillerød Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in disability from baseline	Scandinavian Stroke Scale (SSS)	up to 5 days	No
Secondary	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	up to 5 days	No
Secondary	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)	up to 5 days	No
Secondary	changes and level of activity during up to 5 days of hospitalization	activity counts per day measured by an accelerometer	up to 5 days	No
Secondary	number of complications per patient	all complications are counted from inclusion till day 30 in all patients	up to 30 days	No