Transient Ischemic AttackNCT01629342
Standardized Physical Activities Measured by Accelerometers
An observational study of Transient Ischemic Attack, run by Hillerod Hospital, Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transient Ischemic Attack
- What is being tested?
- Standardized activities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients just prior discharge from Stoke Unit, Neurologic Department, Hillerød Hospital
Who may be able to join
- Previous Transient Ischemic Attack
- age > 18 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Neurologic Department, Hillerød Hospital
Hillerød, 3400
Anna Maria Strømmen, MD, 48297353 ext. +45, amic@noh.regionh.dk
Anna Maria Strømmen, MD
About this study
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
- Being tested
- Standardized activities
- Medical subject headings
- Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized activitiesBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Transient Ischemic Attack Patients | Patients discharged after a Transient Ischemic Attack Receives: Behavioral: Standardized activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity
Activity measured by 5 Actical accelerometers
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Maria Strømmen, Hillerod Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629342
- Sponsor's protocol ID
- H-1-2012-001
- Status last verified
- Jun 2012
- First submitted
- 25 Jun 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Physical Activities Measured by Accelerometers
- ClinicalTrials.gov ID
- NCT01629342
- Acronym / sponsor ID
- H-1-2012-001
- Conditions
- Transient Ischemic Attack
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transient Ischemic Attack Patients | – | Behavioral: Standardized activitiesPatients discharged after a Transient Ischemic Attack |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients just prior discharge from Stoke Unit, Neurologic Department, Hillerød Hospital
Key inclusion criteria (2 listed)
- Previous Transient Ischemic Attack
- age > 18 years
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized activitiesAll 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) | Behavioural | Transient Ischemic Attack Patients |
Primary outcome
Activity
Time frame: 2 days
Activity measured by 5 Actical accelerometers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Ischemic Attack, run by Hillerod Hospital, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Maria Strømmen, MD (48297353 ext. +45, amic@noh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012; AzTrials last refreshed its copy on 27 Oct 2026.