- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01629342
Standardized Physical Activities Measured by Accelerometers
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Hillerød, Denmark, 3400
- Recruiting
- Neurologic Department, Hillerød Hospital
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Principal Investigator:
- Anna Maria Strømmen, MD
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Contact:
- Anna Maria Strømmen, MD
- Phone Number: +45 48297353
- Email: amic@noh.regionh.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Transient Ischemic Attack Patients
Patients discharged after a Transient Ischemic Attack
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All patients do each of the following standardized activities over a course of 2 days:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity
Time Frame: 2 days
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Activity measured by 5 Actical accelerometers
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2 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-1-2012-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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