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

NCT01509924 | Unknown DMC

• 1 other identifier: Tiohundra
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Attack, Transient

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Cognition and Mental Fatigue

  All measures at baseline 3, 6 and 12 month after the event

• Change in 6 MWT

  3, 6 and 12 months

• Change in self reported stages of change

  3, 6, 12 months

• Change from baseline in systolic blood pressure at 12 months

  3, 6, 12 months

• BMI

  12 months

Study Arms (4)

Physical activity on Prescription (PaP)

EXPERIMENTAL

Intervention group receives a PaP for 12 month.

Other: Physical activation on Prescription

Control Group

NO INTERVENTION

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

Cognitiv function in patients with TIA

NO INTERVENTION

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.

Controlgroup Cognitive function

NO INTERVENTION

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.

Interventions

Physical activation on Prescription OTHER

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.

Also known as: PaP

Physical activity on Prescription (PaP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of contraindications to exercise, and no history of stroke

Sponsors & Collaborators

• Tiohundra AB: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Tiohundra

Norrtälje, Stockholms Läns Landsting, 76192, Sweden

Location

MeSH Terms

Conditions

Ischemic Attack, Transient; Mental Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Disa Sommerfeld

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: January 13, 2012
• Study Start: May 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

SE (1)