Parkinson DiseaseESApp PDNCT06481540
SpiroGym App-Aided Cough Rehabilitation
A study testing Expiratory muscle strength training + SpiroGym application and Expiratory muscle strength training in people with Parkinson Disease and Voluntary Peak Cough Strength, run by General University Hospital, Prague at 1 site in Czechia.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Voluntary Peak Cough Strength, mHealth
- What is being tested?
- Expiratory muscle strength training + SpiroGym application and Expiratory muscle strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinsons disease
- Stable dopaminergic medication (stable dose for at least 1 month)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital
Prague, 120 00
Martin Srp, PhD, +420224965513, martin.srp@vfn.cz
Martin Srp, PhD, 224965513, martin.srp@vfn.cz
About this study
Official title: Effect of the SpiroGym App on Voluntary Cough Strength in Parkinson's Disease
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.
Read the detailed description
Goal: To explore the visual feedback effect of the SpiroGym app in EMST on voluntary peak cough
Hypothesis 1: Change in voluntary peak cough flow will be higher in the experimental group than in the active control group after 8weeks and 24 weeks of EMST.
Study Design: A double-blind, randomized controlled trial
- Conditions
- Parkinson Disease, Voluntary Peak Cough Strength, mHealth
- Being tested
- Expiratory muscle strength training + SpiroGym application, Expiratory muscle strength training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory muscle strength training + SpiroGym applicationDevice
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 trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Expiratory muscle strength training + SpiroGym application | Experimental | The experimental arm will undergo 8 weeks of expiratory muscle strength training coupled with SpiroGym app. Receives: 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. Receives: Device: Expiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary peak cough flow
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: 1 week before baseline, baseline, 8 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jan 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the experimental or the active control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Srp, Ph.D., General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481540
- Sponsor's protocol ID
- ESApp PD
- Acronym
- ESApp PD
- Status last verified
- Jan 2025
- First submitted
- 25 Jun 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34631956Troche 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.
PubMed 36345090Troche 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.
PubMed 24933728Reyes 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.
PubMed 31720808
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the SpiroGym App on Voluntary Cough Strength in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06481540
- Acronym / sponsor ID
- ESApp PD / ESApp PD
- Conditions
- Parkinson Disease, Voluntary Peak Cough Strength, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Goal: To explore the visual feedback effect of the SpiroGym app in EMST on voluntary peak cough
Hypothesis 1: Change in voluntary peak cough flow will be higher in the experimental group than in the active control group after 8weeks and 24 weeks of EMST.
Study Design: A double-blind, randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the experimental or the active control group.
| Arm | Type | Receives |
|---|---|---|
| Expiratory muscle strength training + SpiroGym application | Experimental | Device: Expiratory muscle strength training + SpiroGym applicationThe experimental arm will undergo 8 weeks of expiratory muscle strength training coupled with SpiroGym app. |
| Expiratory muscle strength training | Active comparator | Device: Expiratory muscle strength trainingThe experimental arm will undergo 8 weeks of expiratory muscle strength training. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Parkinsons disease
- Stable dopaminergic medication (stable dose for at least 1 month)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expiratory muscle strength training + SpiroGym applicationParticipants 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. | Device | Expiratory muscle strength training + SpiroGym application |
| Expiratory muscle strength trainingParticipants 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. | Device | Expiratory muscle strength training |
Primary outcome
Voluntary peak cough flow
Time frame: 1 week before baseline, baseline, 8 weeks, 24 weeks
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Background: PubMed 34631956Srp 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.
- Background: PubMed 36345090Troche 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.
- Background: PubMed 24933728Troche 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.
- Background: PubMed 31720808Reyes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory muscle strength training + SpiroGym application and Expiratory muscle strength training in people with Parkinson Disease and Voluntary Peak Cough Strength, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Srp, PhD (+420224965513, martin.srp@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary peak cough flow (time frame: 1 week before baseline, baseline, 8 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06481540, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.