Effect of SpiroGym App in Patients With Parkinson's Disease (RespPD)

General University Hospital, Prague

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Expiratory muscle strength training + SpiroGym application; Device: Expiratory muscle strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT05728099

223/20 S-IV

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 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)
• Patient in the risk of non-adherence to the home exercise program (SEHEPS questionnaire below 59 points)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Expiratory muscle strength training + SpiroGym application

Experimental group

Description:

The experimental arm will undergo 24 weeks of expiratory muscle strength training coupled with SpiroGym app.

Treatment:

Device: Expiratory muscle strength training + SpiroGym application

Expiratory muscle strength training

Active Comparator group

Description:

The experimental arm will undergo 24 weeks of expiratory muscle strength training.

Treatment:

Device: Expiratory muscle strength training