Physical Activity Immediately After Acute Cerebral Ischemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Hillerod Hospital, Denmark.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Anna Maria Strømmen, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01594190
First received: November 2, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Acute Ischemic Stroke
Physical Activity
Accelerometer
Behavioral: physical activity 15 minutes/day
Behavioral: physical activity, 2 x 30 minutes/day

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much - a Randomized Controlled Study

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • change in disability from baseline [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    Scandinavian Stroke Scale (SSS)


Secondary Outcome Measures:
  • change in inflammation level from baseline [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose

  • change in disability from baseline [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    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)

  • changes and level of activity during up to 5 days of hospitalization [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    activity counts per day measured by an accelerometer

  • number of complications per patient [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    all complications are counted from inclusion till day 30 in all patients


Estimated Enrollment: 250
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Dose Training
15 minutes/day on a weight-bearing treadmill
Behavioral: physical activity 15 minutes/day
weight-bearing treadmill, pulsereserve increase of 50 %
Active Comparator: High Dose Training
2x 30 minutes/day on a weight-bearing treadmill
Behavioral: physical activity, 2 x 30 minutes/day
weight-bearing treadmill, pulsereserve increase of 50 %

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594190

Contacts
Contact: Anna Maria Strømmen, MD +4548297353 amic@noh.regionh.dk

Locations
Denmark
Hillerød Hospital Not yet recruiting
Hillerød, Denmark, 3400
Contact: Anna Maria Strømmen, MD    +4548297353    amic@noh.regionh.dk   
Principal Investigator: Anna Maria Strømmen, MD         
Sponsors and Collaborators
Hillerod Hospital, Denmark
  More Information

No publications provided

Responsible Party: Anna Maria Strømmen, clinical assistant, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01594190     History of Changes
Other Study ID Numbers: 30704 part 2
Study First Received: November 2, 2011
Last Updated: May 8, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014