Acute Ischemic StrokeNCT01594190
Physical Activity Immediately After Acute Cerebral Ischemia
A study testing physical activity 15 minutes/day and physical activity, 2 x 30 minutes/day in people with Acute Ischemic Stroke and Physical Activity, run by Hillerod Hospital, Denmark at 1 site in Denmark.
Trial summary
Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year. Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Physical Activity, Accelerometer
- What is being tested?
- physical activity 15 minutes/day and physical activity, 2 x 30 minutes/day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Sep 2014
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted with acute ischemic stroke
- age > 18 years
- first stroke or only minor invalidity from previous strokes (mRS 0-2)
- truncal stability
- SSS < 58
Who cannot join
- symptoms attributable to other diseases than ischemic stroke
- debut of symptoms > 48 h prior to admission
- consent not given < 24 h of admission
- pregnancy or lactation
- isolation
- blood sampling generally not possible
Show all 13Show fewer
- allergy due to accelerometer wear
- ulcers or other skin diseases in the area of accelerometer placement
- unstable cardiologic condition (AMI etc.)
- acute high and sustained resting systolic blood pressure where treatment is necessary
- acute heart rhythm disorder where treatment is necessary
- unable to cooperate
- significant orthopedic conditions (fractures etc.)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hillerød Hospital
Hillerød, 3400
Anna Maria Strømmen, MD, +4548297353, amic@noh.regionh.dk
Anna Maria Strømmen, MD
About this study
Official title: Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much - a Randomized Controlled Study
Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.
Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.
Read more
Accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.
Another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.
Clarification of the optimal dose of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.
The purpose of the project is to investigate which dose (15 vs. 2 x 30 minutes) of physical activity on a weight-bearing treadmill in the first 5 days after admission after an ischemic stroke, gives patients the best improvement in neurological dysfunction.
- Conditions
- Acute Ischemic Stroke, Physical Activity, Accelerometer
- Being tested
- physical activity 15 minutes/day, physical activity, 2 x 30 minutes/day
- Medical subject headings
- Ischemic Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity 15 minutes/dayBehavioural
weight-bearing treadmill, pulsereserve increase of 50 %
physical activity, 2 x 30 minutes/dayBehavioural
weight-bearing treadmill, pulsereserve increase of 50 %
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Training | Active comparator | 15 minutes/day on a weight-bearing treadmill Receives: Behavioral: physical activity 15 minutes/day |
| High Dose Training | Active comparator | 2x 30 minutes/day on a weight-bearing treadmill Receives: Behavioral: physical activity, 2 x 30 minutes/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in disability from baseline
Scandinavian Stroke Scale (SSS)
Measured: up to 5 days
Secondary outcomes (4)
change in inflammation level from baseline
biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose
Measured: up to 5 days
change in disability from baseline
National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS), Assessment of Motor and Process Skills (AMPS)
Measured: up to 5 days
changes and level of activity during up to 5 days of hospitalization
activity counts per day measured by an accelerometer
Measured: up to 5 days
number of complications per patient
all complications are counted from inclusion till day 30 in all patients
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 250 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
- NCT01594190
- Sponsor's protocol ID
- 30704 part 2
- Status last verified
- May 2012
- First submitted
- 2 Nov 2011
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01594190
- Acronym / sponsor ID
- 30704 part 2
- Conditions
- Acute Ischemic Stroke, Physical Activity, Accelerometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 8 May 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.
Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.
Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.
Accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.
Another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.
Clarification of the optimal dose of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.
The purpose of the project is to investigate which dose (15 vs. 2 x 30 minutes) of physical activity on a weight-bearing treadmill in the first 5 days after admission after an ischemic stroke, gives patients the best improvement in neurological dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Training | Active comparator | Behavioral: physical activity 15 minutes/day15 minutes/day on a weight-bearing treadmill |
| High Dose Training | Active comparator | Behavioral: physical activity, 2 x 30 minutes/day2x 30 minutes/day on a weight-bearing treadmill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients admitted with acute ischemic stroke
- age > 18 years
- first stroke or only minor invalidity from previous strokes (mRS 0-2)
- truncal stability
- SSS < 58
Key exclusion criteria (13 listed)
- symptoms attributable to other diseases than ischemic stroke
- debut of symptoms > 48 h prior to admission
- consent not given < 24 h of admission
- pregnancy or lactation
- isolation
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 |
|---|---|---|
| physical activity 15 minutes/dayweight-bearing treadmill, pulsereserve increase of 50 % | Behavioural | Low Dose Training |
| physical activity, 2 x 30 minutes/dayweight-bearing treadmill, pulsereserve increase of 50 % | Behavioural | High Dose Training |
Primary outcome
change in disability from baseline
Time frame: up to 5 days
Scandinavian Stroke Scale (SSS)
4 secondary outcomes
change in inflammation level from baseline
Time frame: up to 5 days
change in disability from baseline
Time frame: up to 5 days
changes and level of activity during up to 5 days of hospitalization
Time frame: up to 5 days
number of complications per patient
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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?
A study testing physical activity 15 minutes/day and physical activity, 2 x 30 minutes/day in people with Acute Ischemic Stroke and Physical Activity, 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 5 inclusion and 13 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 9 May 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 (+4548297353, amic@noh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in disability from baseline (time frame: up to 5 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 9 May 2012.