ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01674790
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : March 23, 2018
Sponsor:
Collaborators:
Nova Scotia Health Research Foundation
Dalhousie University
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Marilyn MacKay-Lyons, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Aerobic training Behavioral: Cognitive training Behavioral: Range of motion exercise Behavioral: Unstructured mental activity Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.
Actual Study Start Date : October 13, 2013
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : June 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AEROBIC group
6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
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.

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.

Experimental: COGNITIVE group
6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
Behavioral: Cognitive training
One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.

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.

Experimental: 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.
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.

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

Experimental: 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.
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.

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.




Primary Outcome Measures :
  1. 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.

  2. Raven's matrices test [ Time Frame: 10 weeks ]
    A measure of non-verbal reasoning ability and fluid intelligence.

  3. 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


Secondary Outcome Measures :
  1. Peak oxygen consumption [ Time Frame: 10 weeks ]
  2. Fatigue Severity Scale [ Time Frame: 10 weeks ]
    Brief 9-item questionnaire designed to assess patient fatigue

  3. Cognitive Failures Questionnaire [ Time Frame: 10 weeks ]
    A measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function.

  4. Montreal Cognitive Assessment [ Time Frame: 10 weeks ]
  5. Expression of BDNF and IGF-1 in peripheral blood samples [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674790


Locations
Canada, Nova Scotia
Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, Canada, B3H 4R2
School of Physiotherapy, Dalhousie University
Halifax, Nova Scotia, Canada, B3H 4R2
Sponsors and Collaborators
Marilyn MacKay-Lyons
Nova Scotia Health Research Foundation
Dalhousie University
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Marilyn MacKay-Lyons, PhD Dalhousie University

Responsible Party: Marilyn MacKay-Lyons, Affiliated Scientist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01674790     History of Changes
Other Study ID Numbers: Priming Study
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases