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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aerobic training
Cognitive training
Range of motion exercise
Unstructured mental activity
Sponsored by
Marilyn MacKay-Lyons
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nova Scotia Rehabilitation Centre
  • School of Physiotherapy, Dalhousie University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

AEROBIC group

COGNITIVE group

AEROBIC + COGNITIVE group

CONTROL group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
Raven's matrices test
A measure of non-verbal reasoning ability and fluid intelligence.
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

Secondary Outcome Measures

Peak oxygen consumption
Fatigue Severity Scale
Brief 9-item questionnaire designed to assess patient fatigue
Cognitive Failures Questionnaire
A measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function.
Montreal Cognitive Assessment
Expression of BDNF and IGF-1 in peripheral blood samples

Full Information

First Posted
August 24, 2012
Last Updated
March 21, 2018
Sponsor
Marilyn MacKay-Lyons
Collaborators
Nova Scotia Health Research Foundation, Dalhousie University, Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01674790
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 13, 2013 (Actual)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marilyn MacKay-Lyons
Collaborators
Nova Scotia Health Research Foundation, Dalhousie University, Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AEROBIC group
Arm Type
Experimental
Arm Description
6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
Arm Title
COGNITIVE group
Arm Type
Experimental
Arm Description
6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
Arm Title
AEROBIC + COGNITIVE group
Arm Type
Experimental
Arm Description
6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week.
Arm Title
CONTROL group
Arm Type
Experimental
Arm Description
6-week program of one 20-min session of ROM exercise and one 20-min session of unstructured mental activity 5 days/week.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic training
Intervention Description
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
Intervention Name(s)
Cognitive training
Intervention Description
One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Range of motion exercise
Intervention Description
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
Intervention Name(s)
Unstructured mental activity
Intervention Description
One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.
Primary Outcome Measure Information:
Title
Flanker Test
Description
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.
Time Frame
10 weeks
Title
Raven's matrices test
Description
A measure of non-verbal reasoning ability and fluid intelligence.
Time Frame
10 weeks
Title
Sternberg digit memory task
Description
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
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Peak oxygen consumption
Time Frame
10 weeks
Title
Fatigue Severity Scale
Description
Brief 9-item questionnaire designed to assess patient fatigue
Time Frame
10 weeks
Title
Cognitive Failures Questionnaire
Description
A measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function.
Time Frame
10 weeks
Title
Montreal Cognitive Assessment
Time Frame
10 weeks
Title
Expression of BDNF and IGF-1 in peripheral blood samples
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn MacKay-Lyons, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Rehabilitation Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4R2
Country
Canada
Facility Name
School of Physiotherapy, Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4R2
Country
Canada

12. IPD Sharing Statement

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

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