The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients

Zeng Changhao

Status: Enrolling

Conditions: Orthostatic Hypotension

Treatments: Behavioral: Comprehensive rehabilitation training; Behavioral: Rise-bed Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06255717

KFXL-tiweidixueya

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

The observation group

Experimental group

Description:

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.

Treatment:

Behavioral: Rise-bed Training

Behavioral: Comprehensive rehabilitation training

The control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Comprehensive rehabilitation training