SpiroGym App-Aided Cough Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorGeneral University Hospital, Prague
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Parkinsons disease
Stable dopaminergic medication (stable dose for at least 1 month)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Expiratory muscle strength training + SpiroGym application
DeviceParticipants 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
DeviceParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Expiratory muscle strength training + SpiroGym applicationExperimental treatment 1 intervention
Group B: Expiratory muscle strength trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Voluntary peak cough flow
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame
1 week before baseline, baseline, 8 weeks, 24 weeksSponsors and contacts
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Source ClinicalTrials.gov