JPRN-jRCTs032180105已完成2 期
Effects of cyborg-type robot suit HAL on exercise therapy in patients with chronic heart failure - Effects of HAL on exercise therapy in patients with chronic heart failure
Koike Akira0 个研究点目标入组 31 人开始时间: 2019年2月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
Motion assistance from HAL during the sit-to-stand exercise significantly improved muscle strength in heart failure patients. The lumbar-type HAL may be an effective tool for frailty, a predictor of poor prognosis in heart failure. The HAL technology has the potential to be applied to cardiac rehabilitation, and is expected to be applied to patients with severe heart failure.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who satisfy all the following criteria are targeted.
- •1. A patient who meets health insurance standards of current cardiac rehabilitation (Left ventricular ejection fraction is 40 % or less, brain natriuretic peptide (BNP) is 80 pg / mL or more, peak oxygen uptake obtained from cardiopulmonary exercise test is 80 % or less of normal value) who performed exercise therapy at the University of Tsukuba Hospital.
- •2. A patient who can consent document by himself/herself.
- •3. A patient aged 20 years or older at consent acquisition.
- •4. A patient whose height is approximately within 150-190 cm, whose weight is approximately within 40-100 kg, and who can wearing HAL.
- •5. A patient who can continue hospitalization during the clinical study.
排除标准
- •Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.
- •1. A patient who corresponds to contraindications of exercise, such as decompensated heart failure, unstable angina, symptomatic aortic valve stenosis, symptomatic hypertropic obstructive cardiomyopathy, exercise-induced arrhythmia, acute myocarditis, or systemic inflammatory disease.
- •2. A patient who is not able to attend this study due to orthopedic, central/peripheral nervous-system, or social problem.
- •3. A patient with bleeding tendencies or complications such as osteoporosis / fracture which are problematic in exercise.
- •4. A patient who cannot be put on the electrode on the skin surface due to a skin disease etc.
- •5. A patient whose informed consent cannot be obtained because of disturbance of his/her consciousness, or cognition disorder.
- •6. A patient who is anticipated to be unable to complete the clinical study by the principal investigator or member doctors of the study.
- •7. A patient who is judged to be medically unstable by the principal investigator or member doctors after comprehensively considering physical findings, blood test findings, etc.
研究者
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