Effect of SpiroGym App in Patients With Parkinson's Disease

NCT ID: NCT05728099

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Expiratory muscle strength training + SpiroGym application

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

Group Type: EXPERIMENTAL

Expiratory muscle strength training + SpiroGym application

Intervention Type: DEVICE

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 .

Expiratory muscle strength training

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

Group Type: ACTIVE_COMPARATOR

Expiratory muscle strength training

Intervention Type: DEVICE

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.

Interventions

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 .

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Martin Srp, Ph.D.

Chief physiotherapist of the rehabilitation section in General University Hospital Prague

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Srp, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

General University Hospital, Prague

Locations

General University Hospital

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Martin Srp, Ph.D.

Role: CONTACT

martin.srp@vfn.cz

+420 224 965 513

Facility Contacts

Martin Srp, Ph.D.

Role: primary

martin.srp@vfn.cz

+420 224 965 513

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 31720808 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reyes A, Castillo A, Castillo J, Cornejo I, Cruickshank T. The Effects of Respiratory Muscle Training on Phonatory Measures in Individuals with Parkinson's Disease. J Voice. 2020 Nov;34(6):894-902. doi: 10.1016/j.jvoice.2019.05.001. Epub 2019 May 31.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

223/20 S-IV

Identifier Type: -

Identifier Source: org_study_id