Effect of SpiroGym App in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Expiratory muscle strength training + SpiroGym application
* Device: Expiratory muscle strength training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to either the experimental or the active control group. A simple computer-generated random allocation sequence was completed before study initiation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expiratory muscle strength training + SpiroGym application<br>The experimental arm will undergo 24 weeks of expiratory muscle strength training coupled with SpiroGym app. | Device: Expiratory muscle strength training + SpiroGym application<br>* 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 .<br>|
| Active Comparator: Expiratory muscle strength training<br>The experimental arm will undergo 24 weeks of expiratory muscle strength training. | Device: Expiratory muscle strength training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment adherence | Adherence will be calculated by comparing the total amount of expiratory maneuvers recorded in the patient training logs (active control group) or in the SpiroGym application (experimental group) to the prescribed amount: 1000 manoeuvres during baseline to week 8 and 800 manoeuvres during weeks 8-24. | Adherence for home exercise programs from baseline to end of the study (24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum expiratory pressure (MEP) | MEP assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines. Assessments will be performed using a flanged rubber mouthpiece connected to a pressure manometer (Micro RPM, Micro Medical).The maximum value of three expiratory maneuvers that vary by less than 10%. However, results of published studies confirms a learning effect in the MEP measurements. In order to eliminate the learning effect, the patients will be examined twice within one week. The value from the second measurement will be taken as the baseline MEP value. Aditionaly to decrease the test's variability, a 'warm up session' will be incorporated prior to MEP measurements. | 1 week before baseline, baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 24 weeks | 
| The Self-Efficacy scale for home exercise programs | The Self-Efficacy scale for home exercise programs is a tool for evaluating a patient's self-efficacy for home-based exercise programs. The minimum value is 0 and the maximum value is 72. Higher score mean higher self-efficacy for performing home exercise programs. | baseline, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Expiratory muscle strength training, Adherence