Recruiting · registry statusBreathing-out exercises against resistance
This study tests a breathing exercise device over 24 weeks in people with Parkinson's.
Testing a treatment or activity · Study reference: JPRN-UMIN000059623
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
Open the official registry record ↗Follow this study
Results reported
- Start (reported date)
- 2025-08-20
- Study finished (reported date)
- 2028-03-31
Planned dates can move. A study finishing does not tell us when a paper will be published.
Read the results reported in the registry
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 20years-old to 85years-old · Ask the team who can join
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: male and female
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: 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.
Full study name & original research details
Official study title
Evaluation of the Effects of Expiratory Pressure Load Training in Parkinson's Disease - EPT-PD
Short title used by the registry
Evaluation of the Effects of Expiratory Pressure Load Training in Parkinson's Disease
Original description
Intervention:
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.
Primary outcome:
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 outcome:
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
Conditions reported: Parkinson's disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- 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 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.
- Phases
- Not selected
- Sponsor
- NHO Osaka Toneyama Medical Center
- Start date reported by registry
- 2025-08-20 (reported)
Registry updated: Not reported · Status last verified by the registry submitter: Not reported
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Miki Yoshikawa · +81-6-6853-2001 · 410-chiken@mail.hosp.go.jp
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Facility not reported
Japan
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.