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

Sponsor
Marilyn MacKay-Lyons (Other)
Overall Status
Completed
CT.gov ID
NCT01674790
Collaborator
Nova Scotia Health Research Foundation (Other), Dalhousie University (Other), Heart and Stroke Foundation of Canada (Other)
22
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4
44.1
11
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic training
  • Behavioral: Cognitive training
  • Behavioral: Range of motion exercise
  • Behavioral: Unstructured mental activity
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.
Actual Study Start Date :
Oct 13, 2013
Actual Primary Completion Date :
Jun 16, 2017
Actual Study Completion Date :
Jun 16, 2017

Arms and Interventions

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: Cognitive training
One 20-min session of cognitive training (computerized dual n-back training program) 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: 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.

Outcome Measures

Primary Outcome Measures

  1. Flanker Test [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 [10 weeks]

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

  3. Sternberg digit memory task [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 Outcome Measures

  1. Peak oxygen consumption [10 weeks]

  2. Fatigue Severity Scale [10 weeks]

    Brief 9-item questionnaire designed to assess patient fatigue

  3. Cognitive Failures Questionnaire [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 [10 weeks]

  5. Expression of BDNF and IGF-1 in peripheral blood samples [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nova Scotia Rehabilitation Centre Halifax Nova Scotia Canada B3H 4R2
2 School of Physiotherapy, Dalhousie University Halifax Nova Scotia Canada B3H 4R2

Sponsors and Collaborators

  • Marilyn MacKay-Lyons
  • Nova Scotia Health Research Foundation
  • Dalhousie University
  • Heart and Stroke Foundation of Canada

Investigators

  • Principal Investigator: Marilyn MacKay-Lyons, PhD, Dalhousie University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marilyn MacKay-Lyons, Affiliated Scientist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT01674790
Other Study ID Numbers:
  • Priming Study
First Posted:
Aug 29, 2012
Last Update Posted:
Mar 23, 2018
Last Verified:
Mar 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2018