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

Marilyn MacKay-Lyons

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Unstructured mental activity; Behavioral: Aerobic training; Behavioral: Cognitive training; Behavioral: Range of motion exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01674790

Priming Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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22 participants in 4 patient groups

AEROBIC group

Experimental group

Description:

6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.

Treatment:

Behavioral: Aerobic training

Behavioral: Range of motion exercise

COGNITIVE group

Experimental group

Description:

6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.

Treatment:

Behavioral: Cognitive training

Behavioral: Range of motion exercise

AEROBIC + COGNITIVE group

Experimental group

Description:

6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week.

Treatment:

Behavioral: Aerobic training

Behavioral: Cognitive training

CONTROL group

Experimental group

Description:

6-week program of one 20-min session of ROM exercise and one 20-min session of unstructured mental activity 5 days/week.

Treatment:

Behavioral: Unstructured mental activity

Behavioral: Range of motion exercise