NCT05431127

High Dose Inspiratory Muscle Training in LOPD

High-dose Inspiratory Muscle Training (IMT) in Late-onset Pompe Disease (LOPD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study Objectives: 1) assess the safety and feasibility of high-dose inspiratory muscle training (IMT) delivered remotely in Late-onset Pompe Disease (LOPD) and 2) determine its effects on respiratory and patient-reported outcomes.

Detailed description

This study aims to develop treatments that enhance respiratory strength and function to provide meaningful clinical improvements for people with LOPD. Identification of a cost-effective adjunctive intervention to address respiratory weakness remains critical to reduce disease burden, ease activity limitations and participation restrictions, and improve health-related quality of life. The proposed study will provide a high-dose inspiratory muscle training (IMT) stimulus to enhance treatment efficacy and efficiency. Our hypothesis is that high-dose IMT is necessary to produce meaningful changes in respiratory muscle strength and other outcomes in participants with LOPD.

Conditions

• Late-Onset Pompe Disease
• Lysosomal Disease

Interventions

Type	Name	Description
DEVICE	IMT therapy using the Pr02 mobile device	Inspiratory Muscle Training using a device used to measure and increase respiratory strength and performance through resisted breathing exercises.

Timeline

• Start date: 2022-07-19
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2022-06-24
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States