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

NCT ID: NCT01674790

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-13

Study Completion Date

2017-06-16

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AEROBIC group

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

Group Type EXPERIMENTAL

Aerobic training

Intervention Type BEHAVIORAL

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.

Range of motion exercise

Intervention Type BEHAVIORAL

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.

COGNITIVE group

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

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

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

Range of motion exercise

Intervention Type BEHAVIORAL

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.

AEROBIC + COGNITIVE group

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

Group Type EXPERIMENTAL

Aerobic training

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

CONTROL group

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

Group Type EXPERIMENTAL

Range of motion exercise

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.

Interventions

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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.

Intervention Type BEHAVIORAL

Cognitive training

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Scotia Health Research Foundation

OTHER_GOV

Sponsor Role collaborator

Dalhousie University

OTHER

Sponsor Role collaborator

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

Marilyn MacKay-Lyons

OTHER

Sponsor Role lead

Responsible Party

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Marilyn MacKay-Lyons

Affiliated Scientist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marilyn MacKay-Lyons, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Locations

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Nova Scotia Rehabilitation Centre

Halifax, Nova Scotia, Canada

Site Status

School of Physiotherapy, Dalhousie University

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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Priming Study

Identifier Type: -

Identifier Source: org_study_id

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