StrokeNCT01674790
Combined Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke
A study testing Aerobic training, Cognitive training and Range of motion exercise in people with Stroke, run by Marilyn MacKay-Lyons at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Aerobic training, Cognitive training and Range of motion exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Oct 2013to 16 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- Have moderate or severe receptive aphasia
- Have terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, B3H 4R2
School of Physiotherapy, Dalhousie University
Halifax, Nova Scotia, B3H 4R2
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Aerobic training, Cognitive training, Range of motion exercise, Unstructured mental activity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingBehavioural
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 trainingBehavioural
One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
Range of motion exerciseBehavioural
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 activityBehavioural
One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.
| Study group | Role | What they receive |
|---|---|---|
| AEROBIC group | Experimental | 6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week. Receives: Behavioral: Aerobic training; Behavioral: Range of motion exercise |
| COGNITIVE group | Experimental | 6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week. Receives: Behavioral: Cognitive training; Behavioral: Range of motion exercise |
| AEROBIC + COGNITIVE group | Experimental | 6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week. Receives: Behavioral: Aerobic training; Behavioral: Cognitive training |
| CONTROL group | Experimental | 6-week program of one 20-min session of ROM exercise and one 20-min session of unstructured mental activity 5 days/week. Receives: Behavioral: Range of motion exercise; Behavioral: Unstructured mental activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Raven's matrices test
A measure of non-verbal reasoning ability and fluid intelligence.
Measured: 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
Measured: 10 weeks
Secondary outcomes (5)
Peak oxygen consumption
Measured: 10 weeks
Fatigue Severity Scale
Brief 9-item questionnaire designed to assess patient fatigue
Measured: 10 weeks
Cognitive Failures Questionnaire
A measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function.
Measured: 10 weeks
Montreal Cognitive Assessment
Measured: 10 weeks
Expression of BDNF and IGF-1 in peripheral blood samples
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study start13 Oct 2013
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marilyn MacKay-Lyons
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Research Foundation, Dalhousie University, Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor-investigator, Marilyn MacKay-Lyons, Nova Scotia Health Authority
- Investigators
- Marilyn MacKay-Lyons, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674790
- Sponsor's protocol ID
- Priming Study
- Status last verified
- Mar 2018
- First submitted
- 24 Aug 2012
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.
- ClinicalTrials.gov ID
- NCT01674790
- Acronym / sponsor ID
- Priming Study
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Marilyn MacKay-LyonsUniversity, hospital or other
- Collaborators
- Nova Scotia Health Research Foundation, Dalhousie University, Heart and Stroke Foundation of Canada
- Study start
- 13 Oct 2013 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AEROBIC group | Experimental | Behavioral: Aerobic training, Behavioral: Range of motion exercise6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week. |
| COGNITIVE group | Experimental | Behavioral: Cognitive training, Behavioral: Range of motion exercise6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week. |
| AEROBIC + COGNITIVE group | Experimental | Behavioral: Aerobic training, Behavioral: Cognitive training6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week. |
| CONTROL group | Experimental | Behavioral: Range of motion exercise, Behavioral: Unstructured mental activity6-week program of one 20-min session of ROM exercise and one 20-min session of unstructured mental activity 5 days/week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (2 listed)
- Have moderate or severe receptive aphasia
- Have terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingOne 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. | Behavioural | AEROBIC + COGNITIVE group, AEROBIC group |
| Cognitive trainingOne 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks. | Behavioural | AEROBIC + COGNITIVE group, COGNITIVE group |
| Range of motion exerciseOne 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. | Behavioural | AEROBIC group, COGNITIVE group, CONTROL group |
| Unstructured mental activityOne 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks. | Behavioural | CONTROL group |
Primary outcome
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
5 secondary outcomes
Peak oxygen consumption
Time frame: 10 weeks
Fatigue Severity Scale
Time frame: 10 weeks
Cognitive Failures Questionnaire
Time frame: 10 weeks
Montreal Cognitive Assessment
Time frame: 10 weeks
Expression of BDNF and IGF-1 in peripheral blood samples
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn MacKay-Lyons, PhD principal investigator
Dalhousie University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training, Cognitive training and Range of motion exercise in people with Stroke, run by Marilyn MacKay-Lyons at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flanker Test (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.