Clinical trial NCT01674790: Combined Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke
Official title: Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Research Foundation
name: Dalhousie University
name: Heart and Stroke Foundation of Canada
First posted: 2012-08-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Flanker Test
timeFrame: 10 weeks
measure: Raven's matrices test
timeFrame: 10 weeks
measure: Sternberg digit memory task
timeFrame: 10 weeks
Secondary outcomes:
measure: Peak oxygen consumption
timeFrame: 10 weeks
measure: Fatigue Severity Scale
timeFrame: 10 weeks
measure: Cognitive Failures Questionnaire
timeFrame: 10 weeks
measure: Montreal Cognitive Assessment
timeFrame: 10 weeks
measure: Expression of BDNF and IGF-1 in peripheral blood samples
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: School of Physiotherapy, Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Marilyn MacKay-Lyons, PhD
role: PRINCIPAL_INVESTIGATOR
References: