Orthostatic HypotensionNCT06255717
The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients
A study testing Comprehensive rehabilitation training and Rise-bed Training in people with Orthostatic Hypotension, run by Zeng Changhao at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Comprehensive rehabilitation training and Rise-bed Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Feb 2024to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Gaoxiong Rehabilitation Hospital
Xinzhu
Sumei Wang, Doctor
About this study
Official title: The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Comprehensive rehabilitation training, Rise-bed Training
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive rehabilitation trainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Comprehensive rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1 and day 21
Secondary outcomes (2)
Orthostatic Hypotension Questionnaire
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.
Measured: day 1 and day 21
Orthostatic Grading Scale
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.
Measured: day 1 and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start29 Feb 2024
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Zhengzhou University
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Study director, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255717
- Sponsor's protocol ID
- KFXL-tiweidixueya
- Status last verified
- Mar 2024
- First submitted
- 4 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06255717
- Acronym / sponsor ID
- KFXL-tiweidixueya
- Conditions
- Orthostatic Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Collaborators
- People's Hospital of Zhengzhou University
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The observation group | Experimental | Behavioral: Comprehensive rehabilitation training, Behavioral: Rise-bed TrainingAssigned 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. |
| The control group | Active comparator | Behavioral: Comprehensive rehabilitation trainingAssigned 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive rehabilitation trainingBasic 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. | Behavioural | The control group, The observation group |
| Rise-bed Traininggradually 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. | Behavioural | The observation group |
Primary outcome
Composite Autonomic Symptom Scale 31
Time frame: 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.
2 secondary outcomes
Orthostatic Hypotension Questionnaire
Time frame: day 1 and day 21
Orthostatic Grading Scale
Time frame: day 1 and day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study director
Site Coordinator of United Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive rehabilitation training and Rise-bed Training in people with Orthostatic Hypotension, run by Zeng Changhao at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianyun Lu, Master (15333866454, 535226944@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Autonomic Symptom Scale 31 (time frame: day 1 and day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.