Patients with thoracic esophageal cancer
Conditions
Interventions
Sham-Expiratory muscle training
Expiratory muscle training
Sponsors
Kindai university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible participants must meet all of the following criteria and provide written informed consent: Patients aged 40 years or older with esophageal cancer scheduled to undergo esophagectomy and reconstruction following neoadjuvant therapy at Kindai University Hospital. Patients receiving initial treatment for esophageal cancer. Patients without severe comorbidities involving major organs (e.g., bone marrow, heart, liver, kidneys). Patients who have received a full explanation of the study and have provided written informed consent. Patients who are able to walk independently.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: Patients scheduled to undergo staged esophageal reconstruction or total laryngectomy. Patients with contraindications to the use of the expiratory muscle training device (EX-1 Medic), including: Patients with asthma who frequently experience exacerbations Patients with tympanic membrane perforation or other ear injuries Patients with markedly elevated left ventricular end-diastolic volume or pressure Patients who have experienced worsening signs or symptoms of heart failure following respiratory muscle training, or those diagnosed by a physician as being at high risk of such deterioration Patients with a history of costochondritis or those diagnosed as likely to have it Patients with active infections or other severe complications* who are judged by the attending physician to be at risk of adverse events associated with expiratory muscle training (EMT), such as increased dyspnea due to respiratory muscle fatigue, decreased consciousness due to hyperventilation, or syncope due to abrupt changes in blood pressure or hemodynamics caused by intrathoracic pressure fluctuations. Patients with disorientation or psychiatric disorders that would preclude appropriate participation in the study. Patients deemed by the investigator or sub-investigator to be unsuitable for EMT due to a high risk of pneumothorax from extensive emphysematous lesions or giant bullae, leading to increased physical burden or potential harm from participation in the study. *Severe complications include severe pneumonia, cardiac disease, hepatic disease, renal disease; patients with cardiac events (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery) within the past month; cerebrovascular disease within the past 6 months; or the presence of extensive emphysematous changes or giant bullae.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Penetration-Aspiration Scale (PAS) score assessed during video-fluoroscopic swallowing study | — |
Secondary
| Measure | Time frame |
|---|---|
| Repeated Saliva Swallowing Test, Functional Oral Intake Scale, Tongue pressure | — |
Countries
Japan
Contacts
Public ContactHiroki Mizusawa
Kindai university hospital Department of rehabilitation medicine
Outcome results
None listed