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

Stroke Clinical Trial

Official title:

Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674790
• Other study ID #: Priming Study
• Status: Completed
• Phase: N/A
• First received: August 24, 2012
• Last updated: March 21, 2018
• Start date: October 13, 2013
• Est. completion date: June 16, 2017

Study information

• Verified date: March 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 16, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Cognitive training
One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Nova Scotia Rehabilitation Centre	Halifax	Nova Scotia
Canada	School of Physiotherapy, Dalhousie University	Halifax	Nova Scotia

Sponsors (4)

Lead Sponsor	Collaborator
Marilyn MacKay-Lyons	Dalhousie University, Heart and Stroke Foundation of Canada, Nova Scotia Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Raven's matrices test	A measure of non-verbal reasoning ability and fluid intelligence.	10 weeks
Primary	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	Peak oxygen consumption		10 weeks
Secondary	Fatigue Severity Scale	Brief 9-item questionnaire designed to assess patient fatigue	10 weeks
Secondary	Cognitive Failures Questionnaire	A measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function.	10 weeks
Secondary	Montreal Cognitive Assessment		10 weeks
Secondary	Expression of BDNF and IGF-1 in peripheral blood samples		10 weeks