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

NCT ID: NCT06255717

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2024-07-31

Brief Summary

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.

Detailed 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.

Conditions

Orthostatic Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Comprehensive rehabilitation training

Intervention Type: BEHAVIORAL

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.

Rise-bed Training

Intervention Type: BEHAVIORAL

gradually elevating the bed (head-up tilt) is one of the common methods to treat orthostatic hypotension. This treatment adjusts the patient's bed angle to gradually raise their body, promoting balanced blood distribution throughout the body and reducing orthostatic hypotension symptoms.

In head-up tilt treatment, the bed angle is usually gradually increased from a horizontal position, and the specific angle can be determined based on the patient's condition and tolerance. This treatment process is generally monitored and controlled by medical personnel to ensure safety and effectiveness.

The mechanism of head-up tilt treatment is to increase venous return by changing the body position and increasing the effect of gravity, thereby increasing cardiac preload, output, and blood pressure. This helps to reduce orthostatic hypotension symptoms such as dizziness, lightheadedness, and fatigue.

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.

Group Type: ACTIVE_COMPARATOR

Comprehensive rehabilitation training

Intervention Type: BEHAVIORAL

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.

Interventions

Comprehensive rehabilitation training

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.

Intervention Type: BEHAVIORAL

Rise-bed Training

gradually elevating the bed (head-up tilt) is one of the common methods to treat orthostatic hypotension. This treatment adjusts the patient's bed angle to gradually raise their body, promoting balanced blood distribution throughout the body and reducing orthostatic hypotension symptoms.

In head-up tilt treatment, the bed angle is usually gradually increased from a horizontal position, and the specific angle can be determined based on the patient's condition and tolerance. This treatment process is generally monitored and controlled by medical personnel to ensure safety and effectiveness.

The mechanism of head-up tilt treatment is to increase venous return by changing the body position and increasing the effect of gravity, thereby increasing cardiac preload, output, and blood pressure. This helps to reduce orthostatic hypotension symptoms such as dizziness, lightheadedness, and fatigue.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

People's Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Zeng Changhao

OTHER

Sponsor Role: lead

Responsible Party

Zeng Changhao

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis, Master

Role: STUDY_DIRECTOR

Site Coordinator of United Medical Group

Locations

Gaoxiong Rehabilitation Hospital

Xinzhu, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Qianyun Lu, Master

Role: CONTACT

535226944@qq.com

15333866454

Yi Li, Master

Role: CONTACT

liweijia@163.com

17839973473

Facility Contacts

Sumei Wang, Doctor

Role: primary

Other Identifiers

KFXL-tiweidixueya

Identifier Type: -

Identifier Source: org_study_id