The Effects of a High Intensity Gait Training in Improving Oxygen Consumption in Chronic Stroke Patients: a Randomized Control Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- 6 minutes walking test (6-MWT)
研究概览
简要总结
Stroke is a global health-care problem that is common, serious and disabling. In most countries, stroke is second or third most common cause of death and one of the main causes of acquired adult disability. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. After completion of conventional physical therapy, there are no empiric recommendations and few resources promoting regular exercise during the chronic stroke period.Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.
详细描述
Stroke is a major cause of chronic disability worldwide. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. Comorbid cardiovascular conditions are present in 75% of stroke patients, representing the leading cause of death in stroke survivors. Due to the low levels of physical activity, stroke survivors are deconditioned, leading to a loss of functional and social independence with subsequent declines in quality of life. Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.
The first aim of the study is to evaluate the effects of a high intensitive physical training in improving cardiorespiratory fitness and gait ability in chronic stroke patients. The second aim is to compare the effects of high aerobic interval treadmill training and maximal strength training in chronic stroke patients.
Patients will be randomized into three groups. The first group (experimental group) will be subjected to 3-month training period (3 sessions/week) of high intensity aerobic training on treadmill. The second group (experimental group group) will undergo to a strength training with the same duration and frequency of the first group. The third group (control group)will be subjected to conventional training with the same duration and frequency of the experimental groups. Data will be analysed by means parametric and non-parametric tests. Both, within and between groups comparison will be performed.
As primary outcomes measures will be considered the peak oxygen uptake, walking energy cost, 6 minutes walking test. As secondary outcomes measures will be considered the 10-meter Walking Test,Time Up and Go test, Activities- specific balance confidence scale, SF-36 Health Survey Questionnaire, Stroke Impact Scale, Oxygen Uptake Efficiency Slope (OUES), arterial-venous oxygen difference; cardiac output and muscle strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ischemical brain injury or intracerebral hemorrhage by MRI or computed tomography at least 6 months before the onset of the study;
- •Ability to walk in the treadmill at >0.3 km/h for 3 minutes handrail support;
- •Be able to give informed consent and be motivated to participate in 3- month intensive physical fitness training.
排除标准
- •Mini Mental State Examination <20;
- •Unstable angina pectoris;
- •Unstable cardiac conditions;
- •Complex ventricular arrhythmia;
- •Resting systolic blood pressure >200 mm/Hg - Resting diastolic blood pressure >100 mm/Hg;
- •Aphasia (unable to follow two commands);
- •Other medical conditions precluding participation in aerobic exercise.
结局指标
主要结局
6 minutes walking test (6-MWT)
时间窗: All patients enrolled in the study will be evaluated at baseline time 0 of treatment and after after 12 weeks of training.
this is a validated tool evaluating walking capacity. Subjects will be required to walk at their maximum speed for 6 minutes and the score will be the covered distance.
次要结局
- 10 meters Walking test (10-MtWT)(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Time Up and Go Test (TUG)(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Strength(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Arterial - venous oxygen difference (a-v O2 diff)(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Cardiac Output (CO)(Basline, Post- training, Follow- up 6 and 9 months)
- Gait analysis(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Oxygen Uptake Efficiency Slope (OUES)(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- SF-36 Health Survey Questionnaire(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Stroke Impact scale(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Walking energy cost (Wc)(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Activities- specific Balance Confidence Scale:(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
- Peak of Oxygen Consumption (VO2peak)(Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training)
研究者
Nicola Smania, MD, Clinical Professor
Associate professor
Universita di Verona