Clinical trial NCT06942533: Effect of Visual Feedback From the SpiroGym Mobile Application
Official title: The Effect of Visual Feedback From the SpiroGym Mobile Application on Expiratory Muscle Strength Training Performance in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease, Breathing Exercises, Visual Feedback
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each PD patient will complete two EMST separated by a two-week period. One EMST will include feedback via the SpiroGym mobile application, while the other will proceed without such feedback. The order of these conditions will be randomly assigned. The patients cannot be fully blinded in this trial, as they may subjectively perceive differences between conditions. However, they will be partially blinded by withholding information about the study's hypothesis. Patients will only be informed that the study compares different strategies for expiratory muscle training. If a patient asks which intervention is more effective, the examiner will respond that both training methods are expected to be equally effective.
Primary purpose: TREATMENT

Brief summary: The previous pilot study showed that two weeks of intensive expiratory muscle strength training (EMST) coupled with SpiroGym were sufficient to significantly improve the participants' voluntary peak cough flow (PCF). The improvement was quantitatively comparable to the results of other intensive EMST studies with longer durations. When interpreting such rapid improvement, the impact of SpiroGym's visual feedback was considered. It was assumed that visual feedback increased training effort compared to regular training without immediate control.

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 as a prospective crossover experimental design. Patients with Parkinson's disease will complete two EMST sessions (at 75% of maximum expiratory pressure), separated by a two-week period. One EMST session will include feedback via the SpiroGym mobile application, while the other will be conducted without such feedback. The order of these conditions will be randomly assigned.

Primary hypothesis

Visual feedback provided by the SpiroGym application during expiratory training will result in higher muscle activation, as measured by surface electromyography (sEMG), compared to training without visual feedback.

Secondary hypothesis

1. Participants using visual feedback during expiratory training will demonstrate greater expiratory performance, reflected by higher noise intensity recorded by the SpiroGym application, than participants training without visual feedback.
2. Participants will report lower perceived difficulty and higher motivation to perform expiratory training exercises when visual feedback is provided, compared to when it is absent.

Eligibility criteria: 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

Primary outcomes:
measure: Surphace elektromyography (sEMG) measurement of suprahyoid muscle complex and abdominal muscles.
timeFrame: Baseline, week 2
Secondary outcomes:
measure: SpiroGym Sound Intenzity (SSI) measurement
timeFrame: Baseline, week 2
measure: Participant's Feedback
timeFrame: week 2
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General University Hospital
Study officials:
References:
citation: Srp M, Bartosova T, Klempir J, Lagnerova R, Gal O, Listvanova T, Jech R, Ruzicka E, Hoskovcova M. Expiratory Muscle Strength Training in Multiple System Atrophy: A Pilot Study. Mov Disord Clin Pract. 2023 May 19;10(7):1060-1065. doi: 10.1002/mdc3.13765. eCollection 2023 Jul.