Ischemic Attack, TransientNCT01509924
Cognitive and Physical Functions in Patients With Transient Ischemic Attack. A Randomized Controlled Trial of Physical Activity on Prescription up to One Year After the Event
A study testing Physical activation on Prescription in people with Ischemic Attack, Transient, run by Tiohundra AB at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether Physical Activation on Prescription can help patients with TIA to become more physically active. One group will receives Physical Activation on Prescription (PaP)and the other group will receives usual care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Attack, Transient
- What is being tested?
- Physical activation on Prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- May 2010to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Understand Swedish language (also in and writing), living in Norrtälje community,
- To participate in the assessment of cognitive function: no known cognitive impairments before the TIA event and history of stroke.
Who cannot join
- Presence of contraindications to exercise, and no history of stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive and Physical Functions in Patients With TIA. A Randomized Controlled Trial of Physical Activity on Prescription up to One Year After the Event
The purpose of this study is to determine whether Physical Activation on Prescription can help patients with TIA to become more physically active.
One group will receives Physical Activation on Prescription (PaP)and the other group will receives usual care.
And to identify if persons with TIA presents with cognitive impairments.
Read the detailed description
Transient ischemic attack (TIA) is a transient episode of neurologic dysfunction caused by ischemia, i.e. loss of blood flow. The symptoms of a TIA typically resolve within 24 hours. Attacks lasting more than 30 minutes are unusual. TIAs and strokes present with the same symptoms such as sudden weakness, numbness, sudden dimming or loss of vision, aphasia, slurred speech, facial palsy and mental impairments. Subtle problems with cognitive functions and fatigue may not always be addressed before discharge. However, even subtle mental impairments are important to identify, given the problems they might pose.
- Conditions
- Ischemic Attack, Transient
- Being tested
- Physical activation on Prescription
- Keywords
- Walking capacity, Mental Fatigue, Quality of Life, Cognition, Motor activity, Exercise
- Medical subject headings
- Ischemic Attack, Transient, Mental Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activation on PrescriptionOther
Also called PaP
The advice on physical activity is patient oriented and based on FYSS (FYSS is a information bank that summarizes the up-to-date scientific knowledge on how to prevent and treat various diseases and conditions using physical activity). An individual prescription on physical activity is issued. The prescription form reminds of an ordinary drug prescription and provides specified types of physical activities including intensity, frequency and duration of the respective activities. The prescribed physical activity could be either self-monitored or organized by public physical activity organizations.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity on Prescription (PaP) | Experimental | Intervention group receives a PaP for 12 month. Receives: Other: Physical activation on Prescription |
| Control Group | No intervention | The control group has the same monitoring as the experimental group but receives no PaP. |
| Cognitiv function in patients with TIA | No intervention | Before discharged from hospital cognitive function is assessed. At the first visit the patients fill in a self assessment questionnaire for mental fatigue. If impaired at the previous assessment cognitive function will be assessed at 3, 6 and 12 month. |
| Controlgroup Cognitive function | No intervention | In order to determine whether hospitalization in itself is associated with transient impaired cognition, a comparison group will be included. The comparison group will consist of patients with angina pectoris consecutively admitted to the Norrtälje Hospital. The patients with angina pectoris will be age and sex matched with the patients with TIA and assessed for cognitive function when their angina symptoms have subsided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical activity over time
Physical activity measured with accelerometer (Time frame: Baseline, 3, 6, and 12 month).
Measured: at discharge from hospital, 3, 6 and 12 month after the event
Secondary outcomes (7)
Change in Cognition and Mental Fatigue
Change in mental conditions over time measured with self report of mental fatigue and related symptoms. This is a scale with 7 different steps for graduate mental fatigue. Less points indicate less mental fatigue.
Measured: All measures at baseline 3, 6 and 12 month after the event
Change in 6 MWT
Change in Walking endurance measured in 3, 6, 12 month measured with 6 MWT (six minutes Walking Test).
Measured: 3, 6 and 12 months
Change in self reported stages of change
A self reported questionnaire that measures willingness to changes in physical activity over time. The scale has different levels of willingness for changes in physical activity.
Measured: 3, 6, 12 months
Change from baseline in systolic blood pressure at 12 months
Measured: 3, 6, 12 months
BMI
Body Mass Index is measured at the start and at the end of the study
Measured: 12 months
Change in mental capacity over a period of time
Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.
Measured: 3, 6,12 months
Change in mental capacity over a period of time
Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startMay 2010
- Primary completionApr 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Attack, TransientStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiohundra AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Carina Moren, Tiohundra AB
- Investigators
- Disa Sommerfeld, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509924
- Sponsor's protocol ID
- Tiohundra
- Status last verified
- Sep 2014
- First submitted
- 7 Jun 2011
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Physical Functions in Patients With TIA. A Randomized Controlled Trial of Physical Activity on Prescription up to One Year After the Event
- ClinicalTrials.gov ID
- NCT01509924
- Acronym / sponsor ID
- Tiohundra
- Conditions
- Ischemic Attack, Transient
- Keywords
- Walking capacity, Mental Fatigue, Quality of Life, Cognition, Motor activity, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tiohundra ABIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Study start
- May 2010
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 13 Jan 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.
The purpose of this study is to determine whether Physical Activation on Prescription can help patients with TIA to become more physically active.
One group will receives Physical Activation on Prescription (PaP)and the other group will receives usual care.
And to identify if persons with TIA presents with cognitive impairments.
Detailed description
Transient ischemic attack (TIA) is a transient episode of neurologic dysfunction caused by ischemia, i.e. loss of blood flow. The symptoms of a TIA typically resolve within 24 hours. Attacks lasting more than 30 minutes are unusual. TIAs and strokes present with the same symptoms such as sudden weakness, numbness, sudden dimming or loss of vision, aphasia, slurred speech, facial palsy and mental impairments. Subtle problems with cognitive functions and fatigue may not always be addressed before discharge. However, even subtle mental impairments are important to identify, given the problems they might pose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical activity on Prescription (PaP) | Experimental | Other: Physical activation on PrescriptionIntervention group receives a PaP for 12 month. |
| Control Group | No intervention | –The control group has the same monitoring as the experimental group but receives no PaP. |
| Cognitiv function in patients with TIA | No intervention | –Before discharged from hospital cognitive function is assessed. At the first visit the patients fill in a self assessment questionnaire for mental fatigue. If impaired at the previous assessment cognitive function will be assessed at 3, 6 and 12 month. |
| Controlgroup Cognitive function | No intervention | –In order to determine whether hospitalization in itself is associated with transient impaired cognition, a comparison group will be included. The comparison group will consist of patients with angina pectoris consecutively admitted to the Norrtälje Hospital. The patients with angina pectoris will be age and sex matched with the patients with TIA and assessed for cognitive function when their angina symptoms have subsided. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Understand Swedish language (also in and writing), living in Norrtälje community,
- To participate in the assessment of cognitive function: no known cognitive impairments before the TIA event and history of stroke.
Key exclusion criteria (1 listed)
- Presence of contraindications to exercise, and no history of stroke
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 activation on PrescriptionAlso: PaPThe advice on physical activity is patient oriented and based on FYSS (FYSS is a information bank that summarizes the up-to-date scientific knowledge on how to prevent and treat various diseases and conditions using physical activity). An individual prescription on physical activity is issued. The prescription form reminds of an ordinary drug prescription and provides specified types of physical activities including intensity, frequency and duration of the respective activities. The prescribed physical activity could be either self-monitored or organized by public physical activity organizations. | Other | Physical activity on Prescription (PaP) |
Primary outcome
Change in Physical activity over time
Time frame: at discharge from hospital, 3, 6 and 12 month after the event
Physical activity measured with accelerometer (Time frame: Baseline, 3, 6, and 12 month).
7 secondary outcomes
Change in Cognition and Mental Fatigue
Time frame: All measures at baseline 3, 6 and 12 month after the event
Change in 6 MWT
Time frame: 3, 6 and 12 months
Change in self reported stages of change
Time frame: 3, 6, 12 months
Change from baseline in systolic blood pressure at 12 months
Time frame: 3, 6, 12 months
BMI
Time frame: 12 months
Change in mental capacity over a period of time
Time frame: 3, 6,12 months
Change in mental capacity over a period of time
Time frame: 3, 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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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.
Disa Sommerfeld study director
Karolinska Institutet
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 activation on Prescription in people with Ischemic Attack, Transient, run by Tiohundra AB at 1 site in Sweden.
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 1 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 16 Sep 2014. 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical activity over time (time frame: at discharge from hospital, 3, 6 and 12 month after the event). 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 16 Sep 2014.