Multiple system atrophy
Conditions
Interventions
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 increa
Sponsors
NHO Osaka Toneyama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endurance time, assessed by cardiopulmonary exercise testing (constant work rate exercise test). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKeisuke Miki
NHO Osaka Toneyama Medical Center Laboratory of Respiratory Science, Division of Clinical Research
Outcome results
None listed