Parkinson'
Conditions
Interventions
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 pressu
Sponsors
NHO Osaka Toneyama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMiki Yoshikawa
NHO Osaka Toneyama Medical Center Department of Clinical Research - Clinical Research Support / Clinical Trial Management Office
Outcome results
None listed