Standardized Physical Activities Measured by Accelerometers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Hillerod Hospital, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Anna Maria Strømmen, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01629342
First received: June 25, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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 Intervention
Transient Ischemic Attack
Behavioral: Standardized activities

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Activity [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Activity measured by 5 Actical accelerometers


Estimated Enrollment: 25
Study Start Date: June 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients just prior discharge from Stoke Unit, Neurologic Department, Hillerød Hospital

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629342

Contacts
Contact: Anna Maria Strømmen, MD 48297353 ext +45 amic@noh.regionh.dk

Locations
Denmark
Neurologic Department, Hillerød Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Anna Maria Strømmen, MD    48297353 ext +45    amic@noh.regionh.dk   
Principal Investigator: Anna Maria Strømmen, MD         
Sponsors and Collaborators
Hillerod Hospital, Denmark
  More Information

No publications provided

Responsible Party: Anna Maria Strømmen, principal investigator, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01629342     History of Changes
Other Study ID Numbers: H-1-2012-001
Study First Received: June 25, 2012
Last Updated: June 27, 2012
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014