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

Cognitive and Physical Functions in Patients With TIA. 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 Overview

• Status: Unknown
• Conditions: Ischemic Attack, Transient
• Intervention / Treatment: Other: Physical activation on Prescription

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholms Läns Landsting
    • Norrtälje, Stockholms Läns Landsting, Sweden, 76192
      • Tiohundra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change from baseline in systolic blood pressure at 12 months		3, 6, 12 months
BMI	Body Mass Index is measured at the start and at the end of the study	12 months
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
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

Collaborators and Investigators

• Sponsor: Tiohundra AB
• Collaborators: Karolinska Institutet
• Investigators: Study Director: Disa Sommerfeld, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: January 12, 2012
• First Posted (Estimate): January 13, 2012

Study Record Updates

• Last Update Posted (Estimate): September 16, 2014
• Last Update Submitted That Met QC Criteria: September 15, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Exercise; Quality of Life; Cognition; Walking capacity; Motor activity; Mental Fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: Tiohundra