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

NCT06255717 | Recruiting DMC

• 1 other identifier: KFXL-tiweidixueya
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Hypotension

Outcome Measures

Primary Outcomes (1)

• Composite Autonomic Symptom Scale 31

  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.

  day 1 and day 21

Secondary Outcomes (2)

• Orthostatic Hypotension Questionnaire

  day 1 and day 21

• Orthostatic Grading Scale

  day 1 and day 21

Study Arms (2)

The observation group

EXPERIMENTAL

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.

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

The control group

ACTIVE COMPARATOR

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.

Behavioral: Comprehensive rehabilitation training

Interventions

Comprehensive rehabilitation training 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.

The control group; The observation group

Rise-bed Training 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 observation group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeng Changhao: lead
• People's Hospital of Zhengzhou University: collaborator

Study Sites (1)

Gaoxiong Rehabilitation Hospital

Xinzhu, Taiwan

RECRUITING

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY DIRECTOR

Central Study Contacts

Qianyun Lu, Master

CONTACT

15333866454; 535226944@qq.com

Yi Li, Master

CONTACT

17839973473; liweijia@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: February 29, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)