The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Composite Autonomic Symptom Scale 31
研究概览
简要总结
The goal of this clinical trial is to explore raise-bed training Orthostatic Hypotension in Parkinson's Patients. The main question it aims to answer is:
Can raise-bed training improve Orthostatic Hypotension in Parkinson's Patients. Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given raise-bed training. The study lasts 21 days for each patient. Researchers will compare Orthostatic Hypotension Questionnaire, Orthostatic Grading Scale, Composite Autonomic Symptom Scale 31 to see if raise-bed training can help improve the symptom.
详细描述
Orthostatic Hypotension is common in Parkinson's Patients. The goal of this clinical trial is to explore raise-bed training Orthostatic Hypotension in Parkinson's Patients. The main question it aims to answer is:
Can raise-bed training improve Orthostatic Hypotension in Parkinson's Patients. Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given raise-bed training. The study lasts 21 days for each patient. Researchers will compare Orthostatic Hypotension Questionnaire, Orthostatic Grading Scale, Composite Autonomic Symptom Scale 31 to see if raise-bed training can help improve the symptom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Parkinson's disease
- •Presence of orthostatic hypotension, defined as a decrease in systolic blood pressure of at least 20 mmHg or a decrease in diastolic blood pressure of at least 10 mmHg within three minutes of standing up
- •Age 40 years or older
- •Willingness to participate in the study and provide informed consent
排除标准
- •Severe cardiovascular disease or other medical conditions that would make head-up tilt treatment unsafe or inappropriate
- •Use of medications that affect blood pressure or heart rate, such as beta-blockers or vasodilators, and inability or unwillingness to discontinue these medications for the study period
- •History of syncope or falls within the past six months
- •Inability to stand or sit up independently or tolerate changes in body position
- •Cognitive impairment or inability to provide informed consent
研究组 & 干预措施
The observation group
Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
干预措施: Comprehensive rehabilitation training (Behavioral)
The observation group
Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
干预措施: Rise-bed Training (Behavioral)
The control group
Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
干预措施: Comprehensive rehabilitation training (Behavioral)
结局指标
主要结局
Composite Autonomic Symptom Scale 31
时间窗: day 1 and day 21
The scale has a total score range of 0 to 100, with higher scores indicating a higher symptom burden. In this case, a higher score suggests a greater presence of autonomic symptoms, including orthostatic hypotension.
次要结局
- Orthostatic Hypotension Questionnaire(day 1 and day 21)
- Orthostatic Grading Scale(day 1 and day 21)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University