Physical Activity Immediately After Acute Cerebral Ischemia 3

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hillerod Hospital, Denmark
Sponsor:
Information provided by (Responsible Party):
Anna Maria Strømmen, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01712282
First received: October 17, 2012
Last updated: March 13, 2013
Last verified: March 2013
  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 feasibility of treadmill training on a weight-bearing treadmill in the acute phase after admission after an ischemic stroke. Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and whether it changes with treadmill training.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much

Resource links provided by NLM:


Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Level of inflammation, under, during and after treadmill training [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    Biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Necrosis Factor(TNF)-alpha, C-Reactive Protein (CRP), IL-1ra, IL-10, fasting-insulin, fasting-glucose


Secondary Outcome Measures:
  • Correlation of biomarker level [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    Correlation with time, activity counts on an accelerometer, Scandinavian Stroke Scale Score (SSS), 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), Bergs Balance test, age, Body Mass Index and sex

  • Feasibility [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    Whether it is feasible/possible to train patients on a treadmill in the acute phase after ischemic stroke; eg. whether patients are too exhausted to train twice daily, experience complications during training such as nausea or dizziness and therefore can't complete the training programme.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose training
2 x 30 minutes/day on a weight-bearing treadmill
Behavioral: physical activity, 2 x 30 minutes/day
weight-bearing treadmill, pulse reserve 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 score for arm and leg: 10 out of 12 points

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: NCT01712282

Contacts
Contact: Anna M Strømmen, MD +4548297353 anna.maria.stroemmen@regionh.dk

Locations
Denmark
Hillerød Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Anna Maria Strømmen, MD    +4548297353    anna.maria.stroemmen@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: NCT01712282     History of Changes
Other Study ID Numbers: 30704 part 3
Study First Received: October 17, 2012
Last Updated: March 13, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Hillerod Hospital, Denmark:
Physical Activity
Accelerometer

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

ClinicalTrials.gov processed this record on July 26, 2014