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

Not Applicable

• Conditions: Ischemic Attack, Transient
• Interventions: Other: Physical activation on Prescription

• Registration Number: NCT01509924
• Lead Sponsor: Tiohundra AB

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-13
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16
• Primary Completion: 2015-04
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity on Prescription (PaP)	Physical activation on Prescription	Intervention group receives a PaP for 12 month.

Primary Outcome Measures

Name	Time	Method
Change in Physical activity over time	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).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in systolic blood pressure at 12 months	3, 6, 12 months
BMI	12 months	Body Mass Index is measured at the start and at the end of the study
Change in Cognition and Mental Fatigue	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	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	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 in mental capacity over a period of time	3, 6, 12 months	Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.

Trial Locations

Locations (1)

Tiohundra; 🇸🇪 Norrtälje, Stockholms Läns Landsting, Sweden