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

March 21, 2018 updated by: Marilyn MacKay-Lyons

Exploring Potential Synergistic 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4R2
        • Nova Scotia Rehabilitation Centre
      • Halifax, Nova Scotia, Canada, B3H 4R2
        • School of Physiotherapy, Dalhousie University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AEROBIC group
6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
Behavioral: Aerobic training
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.
Behavioral: Range of motion exercise
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.
EXPERIMENTAL: COGNITIVE group
6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
Behavioral: Range of motion exercise
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.
Behavioral: Cognitive training
One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
EXPERIMENTAL: AEROBIC + COGNITIVE group
6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week.
Behavioral: Aerobic training
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.
Behavioral: Cognitive training
One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
EXPERIMENTAL: CONTROL group
6-week program of one 20-min session of ROM exercise and one 20-min session of unstructured mental activity 5 days/week.
Behavioral: Range of motion exercise
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.
Behavioral: Unstructured mental activity
One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks
Raven's matrices test
Time Frame: 10 weeks
A measure of non-verbal reasoning ability and fluid intelligence.
10 weeks
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
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak oxygen consumption
Time Frame: 10 weeks
10 weeks
Fatigue Severity Scale
Time Frame: 10 weeks
Brief 9-item questionnaire designed to assess patient fatigue
10 weeks
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.
10 weeks
Montreal Cognitive Assessment
Time Frame: 10 weeks
10 weeks
Expression of BDNF and IGF-1 in peripheral blood samples
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marilyn MacKay-Lyons

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 13, 2013

Primary Completion (ACTUAL)

June 16, 2017

Study Completion (ACTUAL)

June 16, 2017

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (ESTIMATE)

August 29, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Priming Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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