Standardized Physical Activities Measured by Accelerometers

NCT01629342 | Unknown DMC

• 1 other identifier: H-1-2012-001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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)

Conditions

Transient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

• Activity

  Activity measured by 5 Actical accelerometers

  2 days

Study Arms (1)

Transient Ischemic Attack Patients

Patients discharged after a Transient Ischemic Attack

Behavioral: Standardized activities

Interventions

Standardized activities BEHAVIORAL

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)

Transient Ischemic Attack Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Previous Transient Ischemic Attack
• age \> 18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead

Study Sites (1)

Neurologic Department, Hillerød Hospital

Hillerød, 3400, Denmark

RECRUITING

MeSH Terms

Conditions

Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Anna Maria Strømmen, MD

CONTACT

48297353; amic@noh.regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 27, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

DK (1)