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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01629342
Other study ID # H-1-2012-001
Secondary ID
Status Recruiting
Phase N/A
First received June 25, 2012
Last updated June 27, 2012
Start date June 2012
Est. completion date December 2012

Study information

Verified date June 2012
Source Hillerod Hospital, Denmark
Contact Anna Maria Strømmen, MD
Phone 48297353
Email amic@noh.regionh.dk
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial Summary

STANDARDIZED PHYSICAL ACTIVITIES MEASURED BY ACCELEROMETERS Background and aims: Physical activity may be assessed by several different methods. However, the use of accelerometers is the most direct method available for real-time measurements. The piezoelectric element of accelerometers records an electric voltage during movement which is then transcribed to Activity Counts (AC). Few studies have used Actical accelerometers to assess standardized physical activities and most of these were not applicable to patients in a hospital setting. No previous studies have applied Actical accelerometers to the wrists or ankles during standardized activities. The aim of this study is to record AC during different standardized activities frequently done by patients hospitalized for acute ischemic stroke.

Methods: Patients discharged since February 2012 after a transient ischemic attack have been invited to participate in the study scheduled for June-September 2012 (nexpected=25). All participants wear 5 accelerometers (Actical), one at each wrist and ankle and one over the hip. Standardized physical activities include:

- treadmill walking (5 minutes, 1 and 4km/h)

- staircase walking (1 floor, normal pace)

- cycling with fixed load (5 minutes)

- standing up from sitting position and sitting down again (x5)

- standing up from supine position

- turning from left to right and back while lying in bed

- raising outstretched arm 90° (x5, standing position)

- eating (5 minutes, sitting position)

- drinking a glass of water

- sleeping (6 hours)


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Previous Transient Ischemic Attack

- age > 18 years

Exclusion Criteria:

- pregnancy and lactation

- time limit of more than 2 days of standardized activities exceeded

- no informed consent

- disability when tested with Scandinavian Stroke Scale (score <58), National Institutes of Health Stroke Scale (score >0), modified Rankin Scale (score >0) and Barthels Index 100 (score <100)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Standardized activities
All patients do each of the following standardized activities over a course of 2 days: treadmill walking (5 minutes, 1 and 2km/h) staircase walking (1 floor, normal pace) cycling with fixed load (5 minutes) standing up from sitting position and sitting down again (x5) standing up from supine position turning from left to right and back while lying in bed raising outstretched arm 90° (x5, standing position) eating (5 minutes, sitting position) drinking a glass of water sleeping (6 hours)

Locations

Country Name City State
Denmark Neurologic Department, 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 Activity measured by 5 Actical accelerometers 2 days No
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