This study aims to assess the safety of LVRT and examine the relationship between changes in evaluation metrics in ALS patients.
From February 2019 to August 2023, 24 ALS patients (16 males, 66.7%) meeting inclusion criteria and consenting were studied. The mean age at LVRT initiation was 64.8 ± 10.6 years, with an average disease duration of 33.8 ± 31.1 months. This prospective study assessed ALSFRS-R, Barthel Index (BI), Oral Secretions Scale (OSS), and cognitive function (MMSE, FAB) at LVRT initiation. Data on PEG, NIV, and MI-E use were collected. LVRT was administered using the LIC TRAINER with 5 breaths per set, 3 sets per session, and 2 sessions daily, continued at home. Patients were evaluated at baseline, 2–5 days after LVRT initiation, and at 3, 6, 12, 18, and 36 months. Assessments included FVC, Peak Cough Flow (CPF), Maximum Insufflation Capacity (MIC), MIC-CPF, and LIC. Adverse events like barotrauma were monitored throughout. Friedman test as a nonparametric multiple comparison test with correspondence evaluated significant changes from baseline.
Follow-up was completed by 21 patients at 3 months, 16 at 6 months, 10 at 12 months, 6 at 18 months, and 3 at 36 months. Ultimately, 10 patients required tracheostomy or died, with 6 cases occurring within 12 months of starting LVRT. No LVRT-related adverse events were reported. Significant changes included increases in FVC (p = 0.004) and LIC (p 0.001) post-LVRT and LIC(P0.001) at 3 months. Conversely, FVC, CPF, ALSFRS-R, BI, and OSS showed a significant decline at 3, 6, 12, 18, and 36 months, with the exception of LIC.
In this study, only 3 of the 24 patients completed the final evaluation, reflecting a low implementation rate of 12.5%. This low rate was likely influenced by the rapid progression of ALS, changes in the care environment, and other external factors. Although the small number of patients who were able to receive LVRT for an extended period limits the generalizability of the results, this study demonstrates that LVRT using the LIC TRAINER® is a safe intervention, as no adverse events were reported. Furthermore, LVRT led to improvements in FVC and LIC immediately after initiation, with LIC being maintained even as other indices declined. This suggests the potential for LVRT to preserve lung and thoracic flexibility over time, despite the progressive nature of ALS.
The study highlights LVRT’s potential short-term benefits for ALS patients but suggests limited long-term effects. This emphasizes the need for early intervention, guiding physiotherapy practices and education to optimize respiratory care and influence treatment guidelines.
Lung Volume Recruitment Therapy
Respiratory Function
