Standardized Physical Activities Measured by Accelerometers

Transient Ischemic Attack Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01629342
• Other study ID #: H-1-2012-001
• 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

• Ischemic Attack, Transient
• Transient Ischemic Attack

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