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

NCT ID: NCT01509924

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-07-31

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 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.

Conditions

Ischemic Attack, Transient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical activity on Prescription (PaP)

Intervention group receives a PaP for 12 month.

Group Type: EXPERIMENTAL

Physical activation on Prescription

Intervention Type: OTHER

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.

Control Group

The control group has the same monitoring as the experimental group but receives no PaP.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

PaP

Eligibility 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 contraindications to exercise, and no history of stroke

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Tiohundra AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Carina Moren

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Disa Sommerfeld

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

Tiohundra

Norrtälje, Stockholms Läns Landsting, Sweden

Countries

Sweden

Other Identifiers

Tiohundra

Identifier Type: -

Identifier Source: org_study_id