Standardized Physical Activities Measured by Accelerometers

Sponsor

Hillerod Hospital, Denmark (Other)

Overall Status

Unknown status

CT.gov ID

NCT01629342

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Transient Ischemic Attack	Behavioral: Standardized activities

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Transient Ischemic Attack Patients Patients discharged after a Transient Ischemic Attack	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)

Arm

Intervention/Treatment

Transient Ischemic Attack Patients

Patients discharged after a Transient Ischemic Attack

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)

Outcome Measures

Primary Outcome Measures

Activity [2 days]
Activity measured by 5 Actical accelerometers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurologic Department, Hillerød Hospital	Hillerød		Denmark	3400

Sponsors and Collaborators

Hillerod Hospital, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Maria Strømmen, principal investigator, Hillerod Hospital, Denmark

ClinicalTrials.gov Identifier:

NCT01629342

Other Study ID Numbers:

H-1-2012-001

First Posted:

Jun 27, 2012

Last Update Posted:

Jun 28, 2012

Last Verified:

Jun 1, 2012

Additional relevant MeSH terms:

Ischemic Attack, Transient

Study Results

No Results Posted as of Jun 28, 2012