Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Flanker Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •Have moderate or severe receptive aphasia
- •Have terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
研究组 & 干预措施
AEROBIC group
6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
干预措施: Range of motion exercise (Behavioral)
AEROBIC group
6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
干预措施: Aerobic training (Behavioral)
COGNITIVE group
6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
干预措施: Cognitive training (Behavioral)
COGNITIVE group
6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
干预措施: Range of motion exercise (Behavioral)
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.
干预措施: Aerobic training (Behavioral)
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.
干预措施: Cognitive training (Behavioral)
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.
干预措施: Range of motion exercise (Behavioral)
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.
干预措施: Unstructured mental activity (Behavioral)
结局指标
主要结局
Flanker Test
时间窗: 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.
Raven's matrices test
时间窗: 10 weeks
A measure of non-verbal reasoning ability and fluid intelligence.
Sternberg digit memory task
时间窗: 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
次要结局
- Peak oxygen consumption(10 weeks)
- Fatigue Severity Scale(10 weeks)
- Cognitive Failures Questionnaire(10 weeks)
- Montreal Cognitive Assessment(10 weeks)
- Expression of BDNF and IGF-1 in peripheral blood samples(10 weeks)
研究者
Marilyn MacKay-Lyons
Affiliated Scientist
Nova Scotia Health Authority