NCT05728099

Effect of SpiroGym App in Patients With Parkinson's Disease

Effect of SpiroGym Mobile Application in Expiratory Muscle Strength Training in Patients With Parkinson's Disease: a Double Blind Randomised Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: General University Hospital, Prague · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Expiratory muscle strength training + SpiroGym application	Participants will performe an intensive home-based expiratory muscle training programme using an Expiratory Muscle Trainer (EMST150; Aspire Products, LLC, United States), which provide a pressure- threshold range from 30 to 150 cmH20. EMST therapy sessions will be completed at home on 5 days of the patients choosing per week. Participants will be instructed to perform five sets of five forceful expirations coupled with SpiroGym app. per training session for 8 weeks (intensive training period). For another 16 weeks (maintenance period) participants will be instructed to perform, at least twice per week, five sets of five forceful expirations coupled with SpiroGym app. per training session .
DEVICE	Expiratory muscle strength training	Participants will performe an intensive home-based expiratory muscle training programme using an Expiratory Muscle Trainer (EMST150; Aspire Products, LLC, United States), which provide a pressure- threshold range from 30 to 150 cmH20. EMST therapy sessions will be completed at home on 5 days of the patients choosing per week. Participants will be instructed to perform five sets of five forceful expirations per training session for 8 weeks (intensive training period). For another 16 weeks (maintenance period) participants will be instructed to perform, at least twice per week, five sets of five forceful expirations per training session. Participants will be given the practice log to track training adherence.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-11-01
• Completion: 2025-01-01
• First posted: 2023-02-14
• Last updated: 2023-02-14

Locations

1 site across 1 country: Czechia