Combined Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke
Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.
1 other identifier
interventional
22
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Oct 2013
Longer than P75 for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedStudy Start
First participant enrolled
October 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2017
CompletedMarch 23, 2018
March 1, 2018
3.7 years
August 24, 2012
March 21, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Flanker Test
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
A measure of non-verbal reasoning ability and fluid intelligence.
10 weeks
Sternberg digit memory task
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 Outcomes (5)
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 Arms (4)
AEROBIC group
EXPERIMENTAL6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
COGNITIVE group
EXPERIMENTAL6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
AEROBIC + COGNITIVE group
EXPERIMENTAL6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week.
CONTROL group
EXPERIMENTAL6-week program of one 20-min session of ROM exercise and one 20-min session of unstructured mental activity 5 days/week.
Interventions
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.
One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
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.
One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- Have moderate or severe receptive aphasia
- Have terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marilyn MacKay-Lyonslead
- Nova Scotia Health Research Foundationcollaborator
- Dalhousie Universitycollaborator
- Heart and Stroke Foundation of Canadacollaborator
Study Sites (2)
Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, B3H 4R2, Canada
School of Physiotherapy, Dalhousie University
Halifax, Nova Scotia, B3H 4R2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marilyn MacKay-Lyons, PhD
Dalhousie University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Affiliated Scientist
Study Record Dates
First Submitted
August 24, 2012
First Posted
August 29, 2012
Study Start
October 13, 2013
Primary Completion
June 16, 2017
Study Completion
June 16, 2017
Last Updated
March 23, 2018
Record last verified: 2018-03