UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060786 |
|---|---|
| Receipt number | R000069538 |
| Scientific Title | Clinical effects of upper airway function enhancement via expiratory pressure load training in patients with multiple system atrophy: a single-arm trial |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/02/28 12:03:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical effects of expiratory pressure load training in multiple system atrophy
Acronym
Expiratory pressure load training for multiple system atrophy
Scientific Title
Clinical effects of upper airway function enhancement via expiratory pressure load training in patients with multiple system atrophy: a single-arm trial
Scientific Title:Acronym
Clinical effects of upper airway function enhancement via expiratory pressure load training in multiple system atrophy
Region
| Japan |
Condition
Condition
Multiple system atrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To investigate the hypothesis that expiratory pressure load training in patients with multiple system atrophy yields the following effects: i) improved exercise tolerance due to increased ventilation, ii) reduced nocturnal hypoxemia, and iii) prevention of aspiration.
2) To establish upper airway regulation as a component of pulmonary rehabilitation, that can be expected to be effective regardless of the disease, based on the results of existing clinical research.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endurance time, assessed by cardiopulmonary exercise testing (constant work rate exercise test).
Key secondary outcomes
1. Questionnaires [Unified multiple system atrophy rating scale (UMSARS), Part-1; 10-item Eating Assessment Tool (EAT-10); and Seirei dysphagia screening questionnaire];
2. Height, weight, body mass index (BMI);
3. Pulmonary function: VC, IC, FVC, FEV1, FEV1/FVC, and %FEV1;
4. Cardiopulmonary exercise testing (incremental exercise test and constant work rate exercise test): oxygen uptake (V'O2), minute ventilation (V'E), carbon dioxide output (V'CO2), ventilation equivalent (V'E/V'O2, V'E/V'CO2), breathing frequency (fR), physiologic dead space/tidal volume ratio (VD/VT), expiratory tidal volume (VTex), inspiratory tidal volume (VTin), mean expiratory flow (VTex/TE), mean inspiratory flow (VTin/TI), ratio of inspiratory time to total respiratory cycle time (TI/Ttot), dyspnea and leg fatigue intensity (Borg scale), and oxygen extraction rate, i.e., delta FO2=inspired mean O2 concentration (FIO2)-expired mean O2 concentration (FEO2);
5. Cardiopulmonary exercise testing using laryngoscopy. At rest and submaximal exercise, the maximally dilated glottic area (A), and maximally constricted glottic area (B) will be measured and used to evaluate the following metrics: B/A ratio at rest and submaximal exercise, A at submaximal exercise/A at rest ratio, B at submaximal exercise /B at rest ratio, and inspiratory time ratio at submaximal exercise (time from B to A/time from A to A). All the aforementioned indicators will be calculated as the average of two breaths;
6. Respiratory muscle pressure: maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP);
7. Simple test for sleep apnea syndrome: SpO2 at night;
8. Modified water swallowing test: score of modified water swallowing test, and food intake level scale;
9. Food test: score of food test, and food intake level scale;
10. Simple test, maximum phonation time: MPT;
11. Swallowing videofluorography: findings, penetration-aspiration scale (PAS), food intake level scale.
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
Expiratory pressure load training (EPT)
Duration: 3 months
EPT load levels: Divided into six levels ranging from 20% to 50% of maximum expiratory pressure (MEP). As a general rule, levels are increased by an increment of one every 15 days. However, if the patient cannot tolerate the increase, adjustments, such as increments every approximately 20 days is possible.
EPT frequency: Perform two sets per day (morning and evening), with 30 repetitions per set.
Breathing instructions
Instruct the patient to move while maintaining high expiratory flow rates and sufficient inspiratory volume during both rest and exertion.
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with MSA (MSA-C or MSA-P) according to the Movement Disorder Society (MDS) diagnostic criteria;
2) Patients exhibiting signs supporting MSA, including neck forward flexion, camptocormia (trunk flexion - marked spinal forward flexion), inspiratory sighing, severe dysphonia, severe dysarthria, and pronounced snoring, all indicative of upper airway obstruction;
3) Patients aged 30 years or older, but less than 80 years of age at the time of obtaining consent;
4) Patients who, at the time of consent acquisition, are determined by the physician as being stable, capable of undergoing cardiopulmonary exercise testing using a bicycle ergometer, and able to hold the EPT device themselves to perform training;
5) Patients who provide written consent for study participation.
Key exclusion criteria
1) Patients with malignant tumors, although patients who have remained recurrence-free for two years after treatment may be included;
2) Patients with active infection;
3) Patients with severe heart disease;
4) Patients with asthma;
5) Patients whose drug regimen was changed during this study;
6) Patients requiring oxygen therapy during exercise;
7) Patients who receive pulmonary rehabilitation;
8) Patients with a history of pneumothorax or those with large pulmonary bullae who are at a high risk for pneumothorax;
9) Patients requiring noninvasive positive pressure ventilation;
10) Patients judged by their physician as being unsuitable for participating in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Miki |
Organization
NHO Osaka Toneyama Medical Center
Division name
Laboratory of Respiratory Science, Division of Clinical Research
Zip code
560-8852
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL
0668532001
miki.keisuke.pu@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Miki |
Organization
NHO Osaka Toneyama Medical Center
Division name
Laboratory of Respiratory Science, Division of Clinical Research
Zip code
560-8852
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL
0668532001
Homepage URL
miki.keisuke.pu@mail.hosp.go.jp
Sponsor or person
Institute
NHO Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Research funding has not been secured at this time.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical Research Review Board of NHO Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
Tel
0668532001
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
| 2026 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069538
