Clinical trial NCT06481540: SpiroGym App-Aided Cough Rehabilitation
Official title: Effect of the SpiroGym App on Voluntary Cough Strength in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Voluntary Peak Cough Strength
mHealth
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the experimental or the active control group.
Primary purpose: TREATMENT

Brief summary: The pilot study by Srp et al. (2021) proved that the SpiroGym app was feasible for supporting expiratory muscle strength training (EMST) in Parkinson's disease (PD) patients. Two weeks of intensive 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. However, comparative studies were required to verify the possible additional effects of visual feedback on voluntary PCF compared to EMST without feedback.

Detailed description: Goal: To explore the visual feedback effect of the SpiroGym app in EMST on voluntary peak cough

Hypothesis 1: Change in voluntary peak cough flow will be higher in the experimental group than in the active control group after 8weeks and 24 weeks of EMST.

Study Design: A double-blind, randomized controlled trial

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Other neurological disorders
* Difficulty complying due to neuropsychological dysfunction (dementia with a score of less - - than 19 on the Montreal Cognitive Assessment)
* Breathing disorders or diseases
* Smoking in the past 5 years
* Uncontrolled hypertension

Primary outcomes:
measure: Voluntary peak cough flow
timeFrame: 1 week before baseline, baseline, 8 weeks, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General University Hospital
Study officials:
References:
citation: Srp M, Korteova R, Kliment R, Jech R, Ruzicka E, Hoskovcova M. Expiratory Muscle Strength Training in Patients with Parkinson's Disease: A Pilot Study of Mobile Monitoring Application. Mov Disord Clin Pract. 2021 Aug 4;8(7):1148-1149. doi: 10.1002/mdc3.13313. eCollection 2021 Oct. No abstract available.
citation: Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.
citation: Troche MS, Rosenbek JC, Okun MS, Sapienza CM. Detraining outcomes with expiratory muscle strength training in Parkinson disease. J Rehabil Res Dev. 2014;51(2):305-10. doi: 10.1682/JRRD.2013.05.0101.
citation: Reyes A, Castillo A, Castillo J. Effects of Expiratory Muscle Training and Air Stacking on Peak Cough Flow in Individuals with Parkinson's Disease. Lung. 2020 Feb;198(1):207-211. doi: 10.1007/s00408-019-00291-8. Epub 2019 Nov 12.