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临床试验/NCT02923765
NCT02923765已完成不适用

Efficacy of Stepper Aerobic Training on Cardiopulmonary Fitness, Disability, Systemic Inflammation and Thrombosis in Stroke Patients With Hemiplegia

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Exercise capacity of all participants by Cardiopulmonary ExerciseTest (CPET) and Functional Independence Measure (FIM)

研究概览

简要总结

Stroke rehabilitation of hemiplegics primarily lies in motor control and training of activities of daily life. Whole body aerobics is much less emphasized. Nonetheless, cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy people, which is prone to deconditioning. The present study aims to understand the efficacy of aerobic training in addition to the usual neuro-rehabilitation, including aerobic fitness, daily activities dependency, anti-inflammation and anti-thrombosis. This is a prospective and randomized design. The subjects will be recruited from the hospitalized patients in the rehabilitation ward of Chang Gung Memorial Hospital at Linkuo. 120 hemiplegic patients due to stroke will be enrolled and randomized into two groups: combined training (CT) and usual rehabilitation. Participants in CT will receive aerobics at moderate intensity in addition to the usual rehabilitation. The program has 35 minutes/session, 5 sessions/week and 4-5 weeks in total. A constant-power semi-recumbent stepper will be employed as the training modality. It uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows for a push and pull motion. Additional 20 healthy participants will also be recruited as the healthy control. Assessment before and after training includes: (I) graded cardiopulmonary exercise test using constant-load stepper. (II) Functional Independence Measure. (III) coagulation system assessment, using Thrombin generation assay and Ceveron alpha (Technoclone GmbH, Vienna, Austria) : Von Willebrand factor, tissue plasminogen activator, plasminogen activator inhibitor-1, D-dimer, factor VIII, etc. [the 1st year]; (IV) monocyte-platelet aggregation and its subtypes, using flow cytometry [the 2nd year]. ( V) systemic inflammation, platelet activation and prognostic biomarker:C-reactive protein, soluble P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc [the 3rd year]. Statistical analysis will use ANOVA with post-hoc, two-way repeated measure ANOVA, etc. The investigation will start after approval and end in 2019, July. We hope this investigation will establish a more comprehensive rehabilitation program for clinical application.

详细描述

In Taiwan, there are 220,00 stroke survivors and each year, 10,000 new suffers causing impairment in daily activities. This is the leading cause of disability and consumes 4.5 billions of National Health Insurance yearly. More than half of them become hemi-paretics and hemi-plegics. Stroke leads to the adverse combination of reduced functional capacity and increased energy demands to perform routine activities Thereby, physiologic fitness reserve is diminished. Aerobic fitness is low in stroke survivors. Among ambulatory patients suffering from hemiparetic stroke, the VO2peak is approximately half that of age-matched individuals , a level that is near the minimum range required for activities of daily life. It may limit their ability to perform everyday activities and cause further complications, such as cardiopulmonary de-conditioning, muscular atrophy, joint stiffness, or even learned nonuse.

Many patients are discharged from neurorehabilitation focusing on motor control and ADL (activity of daily life ) training, while aerobic fitness training is neglected, especially in non-ambulatory patients. Randomized exercise training studies using a wide variety of modalities and protocols have demonstrated an 8~23% improvement in VO2peak after 2-6 months of training . However, most research recruit patients with hemiparesis who have mild-to-moderate gait impairment . No specific training protocols has been adequately studied or can be suggested for hemiplegic patients. It is difficult for them to partake in aerobic exercise, like walking or biking. There is a need to develop a new aerobic exercise module suitable for the patients, especially for those with ambulation difficulty resulted from severe paralysis.

In the current investigation, a semi-recumbent stepper with constant power design will be adopted as training modality. It accommodates motor function deficits by providing trunk and distal limb support . In addition, semi- recumbent stepper uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows for a push and pull motion.

Aerobic fitness training has been proposed as a beneficial approach for people with stroke. Taking part in fitness training could have a range of other benefits important to people with stroke such as improving cognitive function, improving mood, and quality of life, and it could reduce the risk of recurrent stroke . In the present investigation, the outcome measurement will not only include cardiopulmonary fitness and the degree of daily activity dependency, but also prognostic biomarkers, thrombotic and inflammatory state.

It is well-documented that exercise training has an anti-thrombotic effect . Increased physical activity and cardiorespiratory fitness are associated with a reduced risk of fatality from cardiovascular diseases. Moreover, increased studies have demonstrated that regular moderate-intensity physical activity is associated with health benefits, even when aerobic fitness (e.g., maximal oxygen uptake, VO2max) remains unchanged . For sedentary persons at risk for cardiovascular disease, adopting a moderately active lifestyle can induce important health benefits, such as reducing prothrombotic factors and lipid peroxidation , increasing fibrinolytic activity and high-density lipoprotein levels , etc. One of the present investigation aims to understand whether 20~25 sessions of aerobic training at moderate intensity will induce these favorable adaptations that could contribute to decreased risk for ischemic event.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Clinical diagnosis of ischemic stroke
  • •Must be able to ride the stepper
  • •No cardiovascular disease in the healthy control group

排除标准

  • •Resting heart rate greater than 100 beats per minute
  • •Atrial fibrillation or flutter
  • •Poor control of high blood pressure or diabetes
  • •Patients with peripheral arterial occlusive disease
  • •Patients with end-stage renal disease
  • •Patients receiving anticoagulant therapy
  • •Neurological instability
  • •Confusion or cognitive dysfunction

研究组 & 干预措施

combined training (CT)

Active Comparator

additional aerobic training by a stepper : 35 minutes/session, 5 sessions/week and 4-5 weeks

干预措施: Aerobic training by a stepper (Other)

usual rehabilitation (UR)

No Intervention

Usual rehabilitation, without additional aerobic training

healthy participant (HP)

No Intervention

healthy control

结局指标

主要结局

Exercise capacity of all participants by Cardiopulmonary ExerciseTest (CPET) and Functional Independence Measure (FIM)

时间窗: three years

CPET

次要结局

  • Thrombosis and Coagulation Activities of Blood Samples of All Participants Enzyme-linked Immunosorbent Assay (ELISA)(three years)
  • Thrombosis and Coagulation Activities of Blood Samples of All Participants by Dynamic TG Assay(three years)
  • Thrombosis and Coagulation Activities of Blood Samples of All Participants by Flow Cytometry,(three years)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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