NCT06942533

Effect of Visual Feedback From the SpiroGym Mobile Application

The Effect of Visual Feedback From the SpiroGym Mobile Application on Expiratory Muscle Strength Training Performance in Patients With Parkinson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: General University Hospital, Prague · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The previous pilot study showed that two weeks of intensive expiratory muscle strength training (EMST) with SpiroGym was sufficient to significantly improve voluntary peak cough flow (PCF). The improvement was quantitatively comparable to that reported in other intensive EMST studies of longer duration. To explain this rapid improvement, we considered the potential contribution of SpiroGym's visual feedback. We assumed that real-time visual feedback increased training effort compared with conventional EMST performed without immediate feedback. The aim of this study is to evaluate the effect of visual feedback provided by the SpiroGym mobile application on performance during expiratory muscle strength training in patients with Parkinson's disease.

Detailed description

The study will be conducted using a prospective crossover design. Patients with Parkinson's disease will complete two EMST sessions, each at 75% of maximum expiratory pressure (MEP), separated by a two-week interval. One EMST session will include feedback via the SpiroGym mobile application, while the other will be performed without feedback. The order of these conditions will be randomly assigned. Primary hypothesis 1. Visual feedback provided by the SpiroGym application during expiratory training will result in greater muscle activation, as measured by surface electromyography (sEMG), compared with training without visual feedback. Secondary hypotheses 2. Visual feedback during expiratory training will lead to greater expiratory performance, reflected by higher noise intensity recorded by the SpiroGym application, than training without visual feedback. 3. Participants will report lower perceived difficulty and higher motivation to perform expiratory training exercises when visual feedback is provided than when it is absent.

Conditions

• Parkinson Disease
• Breathing Exercises
• Telemedicine

Interventions

Type	Name	Description
DEVICE	EMST with SpiroGym app	Participants will perform expiratory muscle training using an Expiratory Muscle Trainer (EMST150; Aspire Products, LLC, United States). Participants will be instructed to perform five sets of five forceful expirations coupled with the SpiroGym app. Video feedback via the SpiroGym app: During correct performance of the expiratory manoeuvre with the handheld device, the exhalation valve opens and the resulting airflow increases the sound level detected by the microphone. Simultaneously, the application provides real-time visual feedback on the mobile phone screen as a curve depicting the current sound level. The patient's task is to keep the curve within the training zone, defined by two lines corresponding to the lower and upper thresholds.
DEVICE	EMST without SpiroGym app	Participants will perform expiratory muscle training using an Expiratory Muscle Trainer (EMST150; Aspire Products, LLC, United States). Participants will be instructed to perform five sets of five forceful expirations without the SpiroGym app.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2025-04-24
• Last updated: 2025-12-01

Locations

2 sites across 1 country: Czechia