Clinical trial NCT06255717: The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients
Official title: The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthostatic Hypotension
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: People's Hospital of Zhengzhou University
First posted: 2024-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Composite Autonomic Symptom Scale 31
timeFrame: day 1 and day 21
Secondary outcomes:
measure: Orthostatic Hypotension Questionnaire
timeFrame: day 1 and day 21
measure: Orthostatic Grading Scale
timeFrame: day 1 and day 21
Other outcomes:
Locations:
city: Xinzhu
country: Taiwan
facility: Gaoxiong Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: