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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Carina Moren, Tiohundra AB
ClinicalTrials.gov Identifier:
NCT01509924
First received: June 7, 2011
Last updated: September 15, 2014
Last verified: September 2014

June 7, 2011
September 15, 2014
May 2010
April 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01509924 on ClinicalTrials.gov Archive Site
  • 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 6 MWT [ Time Frame: 3, 6 and 12 months ] [ 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 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.
  • 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.
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Attack, Transient
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
  • Experimental: Physical activity on Prescription (PaP)
    Intervention group receives a PaP for 12 month.
    Intervention: Other: Physical activation on Prescription
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
July 2015
April 2015   (final data collection date for primary outcome measure)

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 contraindications to exercise, and no history of stroke
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01509924
Tiohundra
Yes
Carina Moren, Tiohundra AB
Tiohundra AB
Karolinska Institutet
Study Director: Disa Sommerfeld Karolinska Institutet
Tiohundra AB
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP