Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01509924
Enrollment
100
Registered
2012-01-13
Start date
2010-05-31
Completion date
2015-07-31
Last updated
2014-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Attack, Transient

Keywords

Walking capacity, Mental Fatigue, Quality of Life, Cognition, Motor activity, Exercise

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.

Interventions

OTHERPhysical 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.

Sponsors

Karolinska Institutet
CollaboratorOTHER
Tiohundra AB
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Physical activity over timeat discharge from hospital, 3, 6 and 12 month after the eventPhysical activity measured with accelerometer (Time frame: Baseline, 3, 6, and 12 month).

Secondary

MeasureTime frameDescription
Change in 6 MWT3, 6 and 12 monthsChange in Walking endurance measured in 3, 6, 12 month measured with 6 MWT (six minutes Walking Test).
Change in self reported stages of change3, 6, 12 monthsA 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 Cognition and Mental FatigueAll measures at baseline 3, 6 and 12 month after the eventChange 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.
BMI12 monthsBody Mass Index is measured at the start and at the end of the study
Change in mental capacity over a period of time3, 6,12 monthsChange in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.
Change from baseline in systolic blood pressure at 12 months3, 6, 12 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026