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

Ischemic Attack, Transient Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01509924
• Other study ID #: Tiohundra
• Status: Active, not recruiting
• Phase: N/A
• First received: June 7, 2011
• Last updated: September 15, 2014
• Start date: May 2010
• Est. completion date: July 2015

Study information

• Verified date: September 2014
• Source: Tiohundra AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Attack, Transient

Intervention

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.

Locations

Country	Name	City	State
Sweden	Tiohundra	Norrtälje	Stockholms Läns Landsting

Sponsors (2)

Lead Sponsor	Collaborator
Tiohundra AB	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical activity over time	Physical activity measured with accelerometer (Time frame: Baseline, 3, 6, and 12 month).	at discharge from hospital, 3, 6 and 12 month after the event	No
Secondary	Change in Cognition and Mental Fatigue	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.	All measures at baseline 3, 6 and 12 month after the event	No
Secondary	Change in 6 MWT	Change in Walking endurance measured in 3, 6, 12 month measured with 6 MWT (six minutes Walking Test).	3, 6 and 12 months	No
Secondary	Change in self reported stages of change	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.	3, 6, 12 months	No
Secondary	Change from baseline in systolic blood pressure at 12 months		3, 6, 12 months	No
Secondary	BMI	Body Mass Index is measured at the start and at the end of the study	12 months	No
Secondary	Change in mental capacity over a period of time	Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.	3, 6,12 months	No
Secondary	Change in mental capacity over a period of time	Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.	3, 6, 12 months	No