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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560520
• Other study ID #: 30704
• Status: Completed
• Phase: N/A
• First received: November 2, 2011
• Last updated: October 17, 2012
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

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 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 describe the amount and pattern of physical activity in stroke patients in the first week after admission. The investigators hypothesis is that patients are inactive for most of the time during hospitalization, activity being correlated with severity of stroke, but not with age, BMI and sex.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients admitted with acute ischemic stroke

• age > 18 years

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

• bloodsampling generally not possible

• allergy due to accelerometer wear

• ulcers or other skin diseases in the area of accelerometer placement

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemic Stroke
• Physical Activity

Intervention

Behavioral:
• Physical activity
Observation only

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	activity counts per day		up to 7 days	No
Secondary	Inflammation level	biomarker concentration	up to 7 days	No
Secondary	Disability	Scandinavian Stroke Scale score (SSS), National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale score (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS)	up to 7 days	No