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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

Primary Purpose

Ischemic Attack, Transient

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical activation on Prescription
Sponsored by
Tiohundra AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Attack, Transient focused on measuring Walking capacity, Mental Fatigue, Quality of Life, Cognition, Motor activity, Exercise

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tiohundra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

No Intervention

No Intervention

Arm Label

Physical activity on Prescription (PaP)

Control Group

Cognitiv function in patients with TIA

Controlgroup Cognitive function

Arm Description

Intervention group receives a PaP for 12 month.

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

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.

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.

Outcomes

Primary Outcome Measures

Change in Physical activity over time
Physical activity measured with accelerometer (Time frame: Baseline, 3, 6, and 12 month).

Secondary Outcome Measures

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.
Change in 6 MWT
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
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 from baseline in systolic blood pressure at 12 months
BMI
Body Mass Index is measured at the start and at the end of the study
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.
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.

Full Information

First Posted
June 7, 2011
Last Updated
September 15, 2014
Sponsor
Tiohundra AB
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01509924
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tiohundra AB
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Attack, Transient
Keywords
Walking capacity, Mental Fatigue, Quality of Life, Cognition, Motor activity, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity on Prescription (PaP)
Arm Type
Experimental
Arm Description
Intervention group receives a PaP for 12 month.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group has the same monitoring as the experimental group but receives no PaP.
Arm Title
Cognitiv function in patients with TIA
Arm Type
No Intervention
Arm Description
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.
Arm Title
Controlgroup Cognitive function
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical activation on Prescription
Other Intervention Name(s)
PaP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Physical activity over time
Description
Physical activity measured with accelerometer (Time frame: Baseline, 3, 6, and 12 month).
Time Frame
at discharge from hospital, 3, 6 and 12 month after the event
Secondary Outcome Measure Information:
Title
Change in Cognition and Mental Fatigue
Description
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.
Time Frame
All measures at baseline 3, 6 and 12 month after the event
Title
Change in 6 MWT
Description
Change in Walking endurance measured in 3, 6, 12 month measured with 6 MWT (six minutes Walking Test).
Time Frame
3, 6 and 12 months
Title
Change in self reported stages of change
Description
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.
Time Frame
3, 6, 12 months
Title
Change from baseline in systolic blood pressure at 12 months
Time Frame
3, 6, 12 months
Title
BMI
Description
Body Mass Index is measured at the start and at the end of the study
Time Frame
12 months
Title
Change in mental capacity over a period of time
Description
Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.
Time Frame
3, 6,12 months
Title
Change in mental capacity over a period of time
Description
Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.
Time Frame
3, 6, 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Disa Sommerfeld
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Tiohundra
City
Norrtälje
State/Province
Stockholms Läns Landsting
ZIP/Postal Code
76192
Country
Sweden

12. IPD Sharing Statement

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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

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