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Trial record 49 of 134 for:    PAP children

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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ClinicalTrials.gov Identifier: NCT01509924
Recruitment Status : Unknown
Verified September 2014 by Carina Moren, Tiohundra AB.
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2012
Last Update Posted : September 16, 2014
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Carina Moren, Tiohundra AB

Tracking Information
First Submitted Date  ICMJE June 7, 2011
First Posted Date  ICMJE January 13, 2012
Last Update Posted Date September 16, 2014
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
Change in Physical activity over time [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01509924 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
  • Change in Cognition and Mental Fatigue [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 from baseline in systolic blood pressure at 12 months [ Time Frame: 3, 6, 12 months ]
  • BMI [ Time Frame: 12 months ]
    Body Mass Index is measured at the start and at the end of the study
  • Change in mental capacity over a period of time [ Time Frame: 3, 6,12 months ]
    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 [ Time Frame: 3, 6, 12 months ]
    Change in mental capacity measured with a assessment called Cognistat that indicates four different levels of mental capacity.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
  • Change in Cognition and Mental Fatigue [ Time Frame: 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 [ Time Frame: 3.6 and 12 month ]
    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 [ Time Frame: 3, 6, 12 months ]
    A self reported questionnaire that measures willingness to changes in physical activity over time. The scale has diffrent levels of willingness for changes in physical activity
  • Change from baseline in systolic Bloodpressure at 12 months [ Time Frame: 3,6,12 ]
  • BMI [ Time Frame: 12 months ]
    Body Mass Index is measured in the start and in the end of the study
  • Change in mental capacity over a period of time [ Time Frame: 3, 6,12 months ]
    Change in mental capacity mesured with a assemssment called Cognistat that indicates four diffrents levels of mental capacity.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Cognitive and Physical Functions in Patients With TIA. A Randomized Controlled Trial of Physical Activity on Prescription up to One Year After the Event
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 Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Attack, Transient
Intervention  ICMJE 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 Name: PaP
Study Arms
  • Experimental: Physical activity on Prescription (PaP)
    Intervention group receives a PaP for 12 month.
    Intervention: Other: Physical activation on Prescription
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date July 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01509924
Other Study ID Numbers  ICMJE Tiohundra
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carina Moren, Tiohundra AB
Study Sponsor  ICMJE Tiohundra AB
Collaborators  ICMJE Karolinska Institutet
Investigators  ICMJE
Study Director: Disa Sommerfeld Karolinska Institutet
PRS Account Tiohundra AB
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP