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Effect of SpiroGym Mobile Application in Expiratory Muscle Strength Training in Patients With Parkinson's Disease: a Double Blind Randomised Control Trial
Airway protective disorders, including swallowing (dysphagia) and cough (dystussia) are common in patients with Parkinson's disease (PD). Disturbances in these protective mechanisms increase the risk of aspiration pneumonia. In fact, aspiration pneumonia is the leading cause of death in individuals with PD. Expiratory muscle strength training (EMST) studies have reported significant improvements in the field of airway protective therapies. EMST represents a treatment that can be quantified and translated into functional outcomes that can directly improve functions related to coughing, swallowing, and speech in patients with PD. However, information about detraining outcomes presented in Troche et al. 2014 highlights the need for the development of long-term maintenance programs to sustain training gains following intensive periods of EMST, especially considering the progressive nature of PD. Low long-term adherence to home exercise is an important issue in many patient groups and may compromise treatment outcomes. In patients with PD, this is further compounded by a wide variety of neuropsychiatric symptoms, such as apathy and depression. Therefore, we developed a mobile phone-based visual feedback application (SpiroGym app.) to keep patients motivated to continue EMST following intensive periods of training. The usability of a SpiroGym app was tested in individuals with PD and the findings indicate that EMST coupled with SpiroGym app is feasible and potentially useful in PD patients. Present study aims to verify and extend the encouraging results of this study which showed a potential self-efficacy benefit of the SpiroGym application.
Goal 1: To explore effect of the SpiroGym apllication on treatment adherence in 24weeks home expiratory strength training. Hypothesis: Treatment adherence will be higher in the experimental group than in the active control group. Goal 2: To explore self-efficacy effect of the SpiroGym aplication in expiratory muscle training. Hypothesis: The SpiroGym application will increase self-eficacy for expiratory muscle strength training. Goal 3: To explore additional visual feedback effect of the SpiroGym application to increase training effort compared with regular training without immediate visual feedback. Hypothesis: Visual feedback of the SpiroGym application will increase training effort in expiratory muscle strength trainning which will be reflected in the MEP values at 8weeks assessment and 24weeks assessment. Study design: a double blind randomised-controlled trial
Age
40 - 80 years
Sex
ALL
Healthy Volunteers
No
General University Hospital
Prague, Czechia
Start Date
March 1, 2022
Primary Completion Date
November 1, 2024
Completion Date
January 1, 2025
Last Updated
February 14, 2023
60
ESTIMATED participants
Expiratory muscle strength training + SpiroGym application
DEVICE
Expiratory muscle strength training
DEVICE
Lead Sponsor
General University Hospital, Prague
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06113640