Physical Activity Immediately After Acute Cerebral Ischemia

NCT01560520 | Completed

• 1 other identifier: 30704
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ischemic Stroke; Physical Activity

Keywords

acute ischemic stroke; accelerometer

Outcome Measures

Primary Outcomes (1)

• activity counts per day

  up to 7 days

Secondary Outcomes (2)

• Inflammation level

  up to 7 days

• Disability

  up to 7 days

Study Arms (1)

Accelerometer

Behavioral: Physical activity

Interventions

Physical activity BEHAVIORAL

Observation only

Also known as: actical, Actical

Accelerometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with stroke admitted acutely to a hospital

You may qualify if:

• patients admitted with acute ischemic stroke
• age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead

Study Sites (1)

Hillerød Hospital

Hillerød, 3400, Denmark

Location

Related Publications (1)

• Strommen AM, Christensen T, Jensen K. Quantitative measurement of physical activity in acute ischemic stroke and transient ischemic attack. Stroke. 2014 Dec;45(12):3649-55. doi: 10.1161/STROKEAHA.114.006496. Epub 2014 Nov 4.

  PMID: 25370584 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose

MeSH Terms

Conditions

Ischemic Stroke; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anna Maria Strømmen, MD

  Neurologic Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical assistant

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: March 22, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

DK (1)