Effect of SpiroGym App in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

— RespPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728099
• Other study ID #: 223/20 S-IV
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2023
• Source: General University Hospital, Prague
• Contact: Martin Srp, Ph.D.
• Phone: +420 224 965 513
• Email: martin.srp[@]vfn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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 .
• 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.

Locations

Country	Name	City	State
Czechia	General University Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
General University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (11)

Chagraoui A, Boukhzar L, Thibaut F, Anouar Y, Maltete D. The pathophysiological mechanisms of motivational deficits in Parkinson's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Feb 2;81:138-152. doi: 10.1016/j.pnpbp.2017.10.022. Epub 2017 Oct 31. — View Citation

Claus I, Muhle P, Czechowski J, Ahring S, Labeit B, Suntrup-Krueger S, Wiendl H, Dziewas R, Warnecke T. Expiratory Muscle Strength Training for Therapy of Pharyngeal Dysphagia in Parkinson's Disease. Mov Disord. 2021 Aug;36(8):1815-1824. doi: 10.1002/mds.28552. Epub 2021 Mar 2. — View Citation

Palazzo C, Klinger E, Dorner V, Kadri A, Thierry O, Boumenir Y, Martin W, Poiraudeau S, Ville I. Barriers to home-based exercise program adherence with chronic low back pain: Patient expectations regarding new technologies. Ann Phys Rehabil Med. 2016 Apr;59(2):107-13. doi: 10.1016/j.rehab.2016.01.009. Epub 2016 Apr 1. — View Citation

Picha KJ, Lester M, Heebner NR, Abt JP, Usher EL, Capilouto G, Uhl TL. The Self-Efficacy for Home Exercise Programs Scale: Development and Psychometric Properties. J Orthop Sports Phys Ther. 2019 Sep;49(9):647-655. doi: 10.2519/jospt.2019.8779. Epub 2019 Jul 10. — View Citation

Pitts T, Bolser D, Rosenbek J, Troche M, Okun MS, Sapienza C. Impact of expiratory muscle strength training on voluntary cough and swallow function in Parkinson disease. Chest. 2009 May;135(5):1301-1308. doi: 10.1378/chest.08-1389. Epub 2008 Nov 24. — View Citation

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. — View Citation

Reyes A, Castillo A, Castillo J. Effects of Expiratory Muscle Training and Air Stacking on Peak Cough Flow in Individuals with Parkinson's Disease. Lung. 2020 Feb;198(1):207-211. doi: 10.1007/s00408-019-00291-8. Epub 2019 Nov 12. — View Citation

Srp M, Korteova R, Kliment R, Jech R, Ruzicka E, Hoskovcova M. Expiratory Muscle Strength Training in Patients with Parkinson's Disease: A Pilot Study of Mobile Monitoring Application. Mov Disord Clin Pract. 2021 Aug 4;8(7):1148-1149. doi: 10.1002/mdc3.13313. eCollection 2021 Oct. No abstract available. — View Citation

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. 2022 Nov 7. doi: 10.1002/mds.29268. Online ahead of print. — View Citation

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. — View Citation

Volianitis S, McConnell AK, Jones DA. Assessment of maximum inspiratory pressure. Prior submaximal respiratory muscle activity ('warm-up') enhances maximum inspiratory activity and attenuates the learning effect of repeated measurement. Respiration. 2001;68(1):22-7. doi: 10.1159/000050458. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MDS-Unified Parkinson's Disease Rating Scale: part III.	This portion of the scale assesses the motor signs of Parkinson´s disease. The minimum value is 0 and the maximum value is 132. Higher score mean The minimum value is 0 and the maximum value is 72. Higher score mean higher patient motor disability.	Baseline, 8 weeks and 24 weeks
Primary	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	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
Secondary	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