Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

And to identify if persons with TIA presents with cognitive impairments.


Detailed Summary: 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.
Sponsor: Tiohundra AB

Current 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Cognition and Mental Fatigue [ Time Frame: All measures at baseline 3, 6 and 12 month after the event ]
    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 6 MWT [ Time Frame: 3, 6 and 12 months ]
    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 months ]
    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.
  • Change from baseline in systolic blood pressure at 12 months [ Time Frame: 3, 6, 12 months ]
  • BMI [ Time Frame: 12 months ]
    Body Mass Index is measured at the start and at the end of the study
  • Change in mental capacity over a period of time [ Time Frame: 3, 6,12 months ]
    Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.
  • Change in mental capacity over a period of time [ Time Frame: 3, 6, 12 months ]
    Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.


Original Secondary Outcome:

  • Change in Cognition and Mental Fatigue [ Time Frame: All measures at baseline 3, 6 and 12 month after the event ]
    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 6 MWT [ Time Frame: 3.6 and 12 month ]
    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 months ]
    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 ]
  • BMI [ Time Frame: 12 months ]
    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 months ]
    Change in mental capacity mesured with a assemssment called Cognistat that indicates four diffrents levels of mental capacity.


Information By: Tiohundra AB

Dates:
Date Received: June 7, 2011
Date Started: May 2010
Date Completion: July 2015
Last Updated: September 15, 2014
Last Verified: September 2014