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

Not Applicable

Not yet recruiting

• Conditions: Orthostatic Hypotension

• Registration Number: NCT06328335
• Lead Sponsor: Copka Sonpashan

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25
• Study Start: 2024-04
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite Autonomic Symptom Scale 31	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.

Secondary Outcome Measures

Name	Time	Method
Orthostatic Hypotension Questionnaire	day 1 and day 21	The Orthostatic Hypotension Questionnaire score ranges 0 to 100 Higher scores on the Orthostatic Hypotension Questionnaire indicate more severe symptoms and a greater impact on quality of life.
Orthostatic Grading Scale	day 1 and day 21	The Orthostatic Grading Scale is typically graded from 0 to 3, with 0 representing no orthostatic hypotension symptoms and 3 representing severe symptoms.; In this case, a lower score on the Orthostatic Grading Scale indicates less severe orthostatic hypotension.