Physical Activity Immediately After Acute Cerebral Ischemia

NCT ID: NCT01594190

Last Updated: 2012-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-09-30

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 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

Acute Ischemic Stroke; Physical Activity; Accelerometer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low Dose Training

15 minutes/day on a weight-bearing treadmill

Group Type: ACTIVE_COMPARATOR

physical activity 15 minutes/day

Intervention Type: BEHAVIORAL

weight-bearing treadmill, pulsereserve increase of 50 %

High Dose Training

2x 30 minutes/day on a weight-bearing treadmill

Group Type: ACTIVE_COMPARATOR

physical activity, 2 x 30 minutes/day

Intervention Type: BEHAVIORAL

weight-bearing treadmill, pulsereserve increase of 50 %

Interventions

physical activity 15 minutes/day

weight-bearing treadmill, pulsereserve increase of 50 %

Intervention Type: BEHAVIORAL

physical activity, 2 x 30 minutes/day

weight-bearing treadmill, pulsereserve increase of 50 %

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hillerod Hospital, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Anna Maria Strømmen

clinical assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hillerød Hospital

Hillerød, , Denmark

Countries

Denmark

Central Contacts

Anna Maria Strømmen, MD

Role: CONTACT

amic@noh.regionh.dk

+4548297353

Facility Contacts

Anna Maria Strømmen, MD

Role: primary

amic@noh.regionh.dk

+4548297353

Other Identifiers

30704 part 2

Identifier Type: -

Identifier Source: org_study_id