Tokyo, Nov. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059623) titled 'Evaluation of the Effects of Expiratory Pressure Load Training in Parkinson's Disease' on Nov. 2.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - NHO Osaka Toneyama Medical Center

Condition: Condition - Parkinson's disease Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 20 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 Size - 20

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068197

Disclaimer: Curated by HT Syndication.