Effect of SpiroGym App in Patients With Parkinson's Disease

NCT05728099 | Unknown

• 1 other identifier: 223/20 S-IV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Expiratory muscle strength training; Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum expiratory pressure (MEP)

  1 week before baseline, baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 24 weeks

• The Self-Efficacy scale for home exercise programs

  baseline, 8 weeks

Other Outcomes (1)

• MDS-Unified Parkinson's Disease Rating Scale: part III.

  Baseline, 8 weeks and 24 weeks

Study Arms (2)

Expiratory muscle strength training + SpiroGym application

EXPERIMENTAL

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

Device: Expiratory muscle strength training + SpiroGym application

Expiratory muscle strength training

ACTIVE COMPARATOR

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

Device: Expiratory muscle strength training

Interventions

Expiratory muscle strength training + SpiroGym application 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 + SpiroGym application

Expiratory muscle strength training 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.

Expiratory muscle strength training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General University Hospital

Prague, 120 00, Czechia

RECRUITING

Related Publications (11)

• 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.

  PMID: 34631956 BACKGROUND

• 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.

  PMID: 31720808 BACKGROUND

• 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.

  PMID: 36345090 BACKGROUND

• 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.

  PMID: 24933728 BACKGROUND

• 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.

  PMID: 27050664 BACKGROUND

• 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.

  PMID: 29097256 BACKGROUND

• 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.

  PMID: 31291552 BACKGROUND

• 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.

  PMID: 33650729 BACKGROUND

• 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.

  PMID: 31155431 BACKGROUND

• 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.

  PMID: 19029430 BACKGROUND

• 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.

  PMID: 11223726 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Martin Srp, Ph.D.

  General University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Srp, Ph.D.

CONTACT

+420 224 965 513; martin.srp@vfn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: During the whole study protocol, patients did not receive information about testing the SpiroGym app. They will receive information that we are testing two types of expiratory muscle strength training programs. Outcomes assessors are blinded to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physiotherapist of the rehabilitation section in General University Hospital Prague

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 14, 2023
• Study Start: March 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)