SpiroGym App-Aided Cough Rehabilitation

NCT06481540 | Recruiting

• 1 other identifier: ESApp PD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The pilot study by Srp et al. (2021) proved that the SpiroGym app was feasible for supporting expiratory muscle strength training (EMST) in Parkinson's disease (PD) patients. Two weeks of intensive EMST coupled with SpiroGym were sufficient to significantly improve the participants' voluntary peak cough flow (PCF). The improvement was quantitatively comparable to the results of other intensive EMST studies with longer durations. When interpreting such rapid improvement, the impact of SpiroGym's visual feedback was considered. It was assumed that visual feedback increased training effort compared to regular training without immediate control. However, comparative studies were required to verify the possible additional effects of visual feedback on voluntary PCF compared to EMST without feedback.

Conditions

Parkinson Disease; Voluntary Peak Cough Strength; mHealth

Outcome Measures

Primary Outcomes (1)

• Voluntary peak cough flow

  Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

  1 week before baseline, baseline, 8 weeks, 24 weeks

Study Arms (2)

Expiratory muscle strength training + SpiroGym application

EXPERIMENTAL

The experimental arm will undergo 8 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 8 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). After this period, participants will perform an additional 16 weeks of maintenance EMST. EMST therapy sessions will be completed at home on two days (minimum) of the participant's choosing each week.

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).After this period, participants will perform an additional 16 weeks of maintenance EMST. EMST therapy sessions will be completed at home on two days (minimum) of the participant's choosing each week.

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)

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 (4)

• 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

• 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

• 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

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

Central Study Contacts

Martin Srp, PhD

CONTACT

+420224965513; 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Model Details: Participants are randomly assigned to either the experimental or the active control group.

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)