UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059623 |
|---|---|
| Receipt number | R000068197 |
| Scientific Title | Evaluation of the Effects of Expiratory Pressure Load Training in Parkinson's Disease |
| Date of disclosure of the study information | 2025/11/02 |
| Last modified on | 2025/11/02 20:24:35 |
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Basic information
Public title
Evaluation of the Effects of Expiratory Pressure Load Training in Parkinson's Disease
Acronym
EPT-PD
Scientific Title
Evaluation of the Effects of Expiratory Pressure Load Training in Parkinson's Disease
Scientific Title:Acronym
EPT-PD
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of expiratory pressure load training (EPT) as a therapeutic intervention for patients with Parkinson's disease.
In addition to examining its effects on swallowing and phonatory functions, this study aims to investigate the potential benefits of EPT on motor symptoms, wearing-off phenomena (daily fluctuations in motor symptoms), and sleep-disordered breathing, including sleep apnea and hypoventilation syndromes, which have not been thoroughly evaluated to date.
Furthermore, this study seeks to establish a sustainable, home-based training program that can be safely continued by patients to maintain and enhance functional outcomes in daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in average daily off period based on self-reported symptom diaries (average of the 7 days prior to assessment at 6 weeks, 12 weeks, and 24 weeks of treatment minus the average of the 7 days prior to baseline assessment)
Key secondary outcomes
1. UPDRS Part III total score: Assessed at baseline, 12 weeks, and 24 weeks
2. PDQ-39 Summary Index and domain scores (see attached materials): Assessed at baseline, 12 weeks, and 24 weeks
3. PDSS-2 score, JESS score, EAT-10 score (see attached materials): Assessed at baseline, 12 weeks, and 24 weeks
4. Evaluation of nocturnal sleep disturbance using the simplified SAS test: AHI score and minimum SpO2 measured at baseline and week 24
5. Swallowing frequency assessment: Hourly swallowing count measured using a laryngeal microphone at baseline and week 24
6. Swallowing endoscopy: Evaluation of silent aspiration of saliva and water swallowing at baseline and week 24
7. Pulmonary function tests (lung volume compartments, spirometry, residual volume): Assessed at baseline, 12 weeks, and 24 weeks. Parameters: VC, IC, FVC, FEV1, FEV1/FVC, %FEV1, RV, RV/TLC, FRC
8. Cardio-Pulmonary Exercise Testing (CPET): Using an ergometer:
8-1. Step test (10W/2min or 10W/min). The choice between the two load protocols is based on the patient's usual activity level.
8-2. Steady-state test (70% of the maximum watts achieved in the previous step test)
9. Respiratory Muscle Strength: Measured using a CHEST device (e.g., VITAROPOWER KH-101). Assessed four times: pre-treatment, 6 weeks, 12 weeks, and 24 weeks. Parameters: MIP and MEP
10. 6-Minute Walk Test: Assessed pre-treatment and at 24 weeks. Parameters: Distance, Minimum SPO2
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Perform EPT twice daily (morning and evening) for 24 weeks, with 30 repetitions per set.
For EPT, use the PowerBreathe EX1 (manufactured by ENTry-japan Co., Ltd., standard or heavy load).
For pressure settings, during the first 12 weeks, start at 20% of the maximum expiratory muscle strength measured before the intervention. If possible, increase by 5% every 2 weeks, aiming for 50%. During the second 12 weeks, continue at 70% of the pressure load reached during the first 12 weeks and provide breathing instruction.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who are diagnosed with Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
2. Patients classified as Hoehn and Yahr stage II to IV.
3. Patients aged 20 years or older and younger than 85 years at the time of obtaining informed consent.
4. Patients who have been treated with levodopa-containing preparations for at least 6 months prior to consent, and who exhibit wearing-off phenomena.
5. Patients who have been receiving a stable dosage and regimen of levodopa-containing preparations (at least three times daily) from the start of the observation period.
6. Patients who are concurrently taking entacapone or opicapone must have been on a stable dosage and regimen since the beginning of the observation period.
7. Patients who are concurrently taking dopamine agonists, amantadine, anticholinergic agents, droxidopa, istradefylline, or zonisamide must have been on a stable dosage and regimen for at least 14 days prior to the start of the observation period.
8. Patients who have provided written informed consent to participate in this study.
Key exclusion criteria
1. Patients with malignant tumors, except those who have completed treatment and have been free from recurrence for at least 5 years.
2. Patients with active infectious diseases.
3. Patients with severe cardiac disease.
4. Patients with bronchial asthma.
5. Patients who undergo changes in medication during the study period.
6. Patients currently receiving respiratory rehabilitation.
7. Patients who require oxygen therapy during exertion.
8. Patients with a history of pneumothorax or those who have large pulmonary bullae and are at high risk of pneumothorax.
9. Patients deemed inappropriate for participation by the investigator for any other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | TAKUYUKI |
| Middle name | |
| Last name | ENDO |
Organization
NHO Osaka Toneyama Medical Center
Division name
Department of Neurology
Zip code
5608552
Address
5-1-1, Toneyama, Toyonaka, Osaka, Japan
TEL
+81-6-6853-2001
endo.takuyuki.gr@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Yoshikawa |
Organization
NHO Osaka Toneyama Medical Center
Division name
Department of Clinical Research - Clinical Research Support / Clinical Trial Management Office
Zip code
5608552
Address
5-1-1, Toneyama, Toyonaka, Osaka, Japan
TEL
+81-6-6853-2001
Homepage URL
410-chiken@mail.hosp.go.jp
Sponsor or person
Institute
NHO Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Osaka Toneyama Medical Center Clinical Research Review Board
Address
5-1-1, Toneyama, Toyonaka, Osaka, Japan
Tel
+81-6-6853-2001
410-chiken@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068197
