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NCT Number: NCT01674790

Combined Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Rehabilitation Centre, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic training

Behavioral

One 20-min session of body weight support treadmill training at moderate to high intensity (60-70% heart rate reserve) 5 days/week for 6-weeks.

Cognitive training

Behavioral

One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.

Range of motion exercise

Behavioral

One 20-min session of range of motion exercise (non-aerobic passive and active movement of upper and lower extremity) 5 days/week for 6-weeks.

Unstructured mental activity

Behavioral

One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.

Primary outcomes

  1. 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.

  2. Raven's matrices test

    Time frame: 10 weeks

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

  3. 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

  1. Peak oxygen consumption

    Time frame: 10 weeks

  2. Fatigue Severity Scale

    Time frame: 10 weeks

    Brief 9-item questionnaire designed to assess patient fatigue

  3. Cognitive Failures Questionnaire

    Time frame: 10 weeks

    A measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function.

  4. Montreal Cognitive Assessment

    Time frame: 10 weeks

  5. Expression of BDNF and IGF-1 in peripheral blood samples

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Marilyn MacKay-Lyons

Other

Collaborators

  • Dalhousie University
  • Heart and Stroke Foundation of Canada
  • Nova Scotia Health Research Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2012
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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