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Clinical Trials/NCT01674790
NCT01674790
Completed
Not Applicable

Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.

Marilyn MacKay-Lyons2 sites in 1 country22 target enrollmentOctober 13, 2013
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Marilyn MacKay-Lyons
Enrollment
22
Locations
2
Primary Endpoint
Flanker Test
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The objective of the 'Exploring potential synergistic effects of aerobic exercise and cognitive training on cognition after stroke' pilot trial is to investigate the combined effects of aerobic and cognitive training on cognition after stroke. This is to lay the groundwork for a larger RCT on the same topic. Twenty patients greater than 6 months post-stroke will be randomly assigned into one of four following treatment groups: (i) aerobic training (AEROBIC group), (ii) cognitive training (COGNITIVE group), (iii) aerobic exercise plus cognitive training (AEROBIC+COGNITIVE group); and (iv) non-aerobic range of motion (ROM) and unstructured mental activity (CONTROL group) (for group descriptions, please see detailed description below). We hypothesize that the combination of aerobic exercise and cognitive training will be more effective in improving cognition after stroke than either treatment on its own.

Detailed Description

Aerobic exercise: Body weight support (BWS) treadmill exercise at moderately high intensity (60-70% of heart rate reserve) using 15-30% BWS. An additional 6-10 min will be needed for warm-up and cool-down. Heart rate will be continuously monitored, and blood pressure and rating of perceived exertion (RPE) will be measured periodically. Cognitive training: Computerized dual n-back training program that involves a working memory task, the difficulty of which adapts to the individual participant's performance. ROM exercise: Non-aerobic passive and active movement of upper and lower extremity joints performed with the subject lying on a plinth. RPE will be recorded every 5 minutes to ensure intensity remains low. Mental activities: Unstructured mental activity: such as listening to light novels on tape, which will be selected by the subject from a pre-determined list.

Registry
clinicaltrials.gov
Start Date
October 13, 2013
End Date
June 16, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Marilyn MacKay-Lyons
Responsible Party
Sponsor Investigator
Principal Investigator

Marilyn MacKay-Lyons

Affiliated Scientist

Nova Scotia Health Authority

Eligibility Criteria

Inclusion Criteria

  • ≥18 years of age
  • Diagnosis of ischemic or hemorrhagic stroke \>6months ago
  • Be able to perform a two-step command
  • Be able to walk ≥10m with/without aid
  • Live within a 75km radius of the QE II
  • Pass a cardiology screen for safe participants in exercise training

Exclusion Criteria

  • Have moderate or severe receptive aphasia
  • Have terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness

Outcomes

Primary Outcomes

Flanker Test

Time Frame: 10 weeks

Flanker Test is a computerized test of selective attention and reaction time that involves a motor response. The participant needs to focus and identify an item presented on a screen while ignoring task-irrelevant distractors. Performance on this test has been shown to improve with exercise.

Raven's matrices test

Time Frame: 10 weeks

A measure of non-verbal reasoning ability and fluid intelligence.

Sternberg digit memory task

Time Frame: 10 weeks

A measure of visual working memory wherein the subject is shown a set of n digits for study. After a short delay, a digit is shown and the subject is asked to recall whether that item was in the previously viewed set

Secondary Outcomes

  • Peak oxygen consumption(10 weeks)
  • Fatigue Severity Scale(10 weeks)
  • Cognitive Failures Questionnaire(10 weeks)
  • Montreal Cognitive Assessment(10 weeks)
  • Expression of BDNF and IGF-1 in peripheral blood samples(10 weeks)

Study Sites (2)

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