Tokyo, March 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060786) titled 'Clinical effects of expiratory pressure load training in multiple system atrophy' on March 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 - Multiple system atrophy
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 30
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 Size - 10
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069538
Disclaimer: Curated by HT Syndication.
