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
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.
|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|
- 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).
- 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.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Physical activity on Prescription (PaP)
Intervention group receives 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509924
|Norrtälje, Stockholms Läns Landsting, Sweden, 76192|
|Study Director:||Disa Sommerfeld||Karolinska Institutet|