This trial is active, not recruiting.

Condition ischemic attack, transient
Treatment physical activation on prescription
Sponsor Tiohundra AB
Collaborator Karolinska Institutet
Start date May 2010
End date April 2015
Trial size 100 participants
Trial identifier NCT01509924, Tiohundra


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Intervention group receives a PaP for 12 month.
physical activation on prescription 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.
(No Intervention)
The control group has the same monitoring as the experimental group but receives no PaP.
(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.
(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.

Primary Outcomes

Change in Physical activity over time
time frame: at discharge from hospital, 3, 6 and 12 month after the event

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
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Tiohundra AB.