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
This study is currently recruiting participants.
Verified January 2012 by Tiohundra AB
Sponsor:
Tiohundra AB
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Carina Moren, Tiohundra AB
ClinicalTrials.gov Identifier:
NCT01509924
First received: June 7, 2011
Last updated: January 12, 2012
Last verified: January 2012
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Purpose
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 receive Physical Activation on Prescription (PaP)and the other group will receive usual care.
And to identify if persons with TIA presents with cognitive impairments.
| Condition | Intervention |
|---|---|
|
Ischemic Attack, Transient |
Other: Physical activation on Prescription |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Tiohundra AB:
Primary Outcome Measures:
- Change in Physical activity over time [ Time Frame: at discharge from hospital, 3, 6 and 12 month after the event ] [ Designated as safety issue: No ]Physical activity measured with accelerometer (Time frame: Baseline, 3, 6, and 12 month).
Secondary Outcome Measures:
- Change in Cognition and Mental Fatigue [ Time Frame: All measures at baseline 3, 6 and 12 month after the event ] [ Designated as safety issue: No ]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.
- Change in 6MWT [ Time Frame: 3.6 and 12 month ] [ Designated as safety issue: No ]Change in Walking endurance measured in 3,6, 12 month measured with 6 MWT (six minutes Walking Test).
- Change in Self reported Stages of change [ Time Frame: 3,6,12 month ] [ Designated as safety issue: No ]A self reported questionnaire that measures willingness to changes in physical activity over time. The scale has diffrent levels of willingness for changes in physical activity
- Change from baseline in systolic Bloodpressure at 12 months [ Time Frame: 3,6,12 ] [ Designated as safety issue: No ]
- BMI [ Time Frame: 12 month ] [ Designated as safety issue: No ]Body Mass Index is measured in the start and in the end of the study
- Change in mental capacity over a period of time [ Time Frame: 3,6,12 month ] [ Designated as safety issue: No ]Change in mental capacity mesured with a assemssment called Cognistat that indicates four diffrents levels of mental capacity.
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Physical activity on Prescription (PaP)
Intervention group receivies a PaP for 12 month.
|
Other: Physical activation on Prescription
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.
Other Name: PaP
|
|
No Intervention: Control Group
The control group has the same monitoring as the experimental group but receives no PaP.
|
|
|
No Intervention: Cognitiv function in patients with TIA
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. |
|
|
No Intervention: Controlgroup Cognitive function
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Presence of contraindicatons to exercise, and no history of stroke
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509924
Contacts
| Contact: Carina E Moren | 0046176326539 | carina.moren@tiohundra.se |
| Contact: Ann-Christine Karlsson | 0046176326539 | ann-christine.karlsson@tiohundra.se |
Locations
| Sweden | |
| Tiohundra | Recruiting |
| Norrtälje, Stockholms Läns Landsting, Sweden, 76192 | |
| Contact: Carina Moren 0046176326539 carina.moren@tiohundra.se | |
| Contact: Ann-Christine Karlsson 0046176326539 ann-christine.karlsson@tiohundra.se | |
Sponsors and Collaborators
Tiohundra AB
Karolinska Institutet
Investigators
| Study Director: | Disa Sommerfeld | Karolinska Institutet |
More Information
No publications provided
| Responsible Party: | Carina Moren, Principal Investigator, Tiohundra AB |
| ClinicalTrials.gov Identifier: | NCT01509924 History of Changes |
| Other Study ID Numbers: | Tiohundra |
| Study First Received: | June 7, 2011 |
| Last Updated: | January 12, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board Sweden: The National Board of Health and Welfare |
Keywords provided by Tiohundra AB:
|
Walking capacity Mental Fatigue Quality of Life |
Cognition Motor activity Exercise |
Additional relevant MeSH terms:
|
Ischemic Attack, Transient Ischemia Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013