Effect of Visual Feedback From the SpiroGym Mobile Application (EXPARK)

General University Hospital, Prague

Status: Enrolling

Conditions: Parkinson Disease; Breathing Exercises; Telemedicine

Treatments: Device: EMST without SpiroGym app; Device: EMST with SpiroGym app

Study type: Interventional

Funder types: Other

Identifiers

NCT06942533

EXPARK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Parkinsons disease
• Stable dopaminergic medication (stable dose for at least 1 month)

Exclusion criteria

• Other neurological disorders
• Significant cognitive impairment
• Major psychiatric disorder
• History of head or neck cancer or previous surgical interventions in the neck region.
• Illness during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

EMST with video feedback via the SpiroGym mobile application

Experimental group

Description:

Patients will complete one EMST session with the SpiroGym app.

Treatment:

Device: EMST with SpiroGym app

EMST without video feedback via the SpiroGym mobile application

Active Comparator group

Description:

Patients will complete one EMST session without the SpiroGym app.

Treatment:

Device: EMST without SpiroGym app