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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Cognitive training Behavioral
    Intervention Desc: One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
    ARM 1: Kind: Experimental
    Label: COGNITIVE group
    Description: 6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
    ARM 2: Kind: Experimental
    Label: AEROBIC + COGNITIVE group
    Description: 6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week.
  • Aerobic training Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: AEROBIC group
    Description: 6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
    ARM 2: Kind: Experimental
    Label: AEROBIC + COGNITIVE group
    Description: 6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week.
  • Range of motion exercise Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: AEROBIC group
    Description: 6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
    ARM 2: Kind: Experimental
    Label: COGNITIVE group
    Description: 6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
    ARM 3: Kind: Experimental
    Label: CONTROL 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.
  • Unstructured mental activity Behavioral
    Intervention Desc: One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.
    ARM 1: Kind: Experimental
    Label: CONTROL 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Flanker Test 10 weeks No
Primary Raven's matrices test 10 weeks No
Primary Sternberg digit memory task 10 weeks No
Secondary Peak oxygen consumption 10 weeks No
Secondary Fatigue Severity Scale 10 weeks No
Secondary Cognitive Failures Questionnaire 10 weeks No
Secondary Montreal Cognitive Assessment 10 weeks No
Secondary Expression of BDNF and IGF-1 in peripheral blood samples 10 weeks No

Sponsors