mHealth, Parkinson Disease, Voluntary Peak Cough Strength
Conditions
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.
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
Interventions
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.
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.
Sponsors
General University Hospital, Prague
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are randomly assigned to either the experimental or the active control group.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Parkinsons disease * Stable dopaminergic medication (stable dose for at least 1 month)
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Voluntary peak cough flow | 1 week before baseline, baseline, 8 weeks, 24 weeks | Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines. |
Countries
Czechia
Contacts
Primary ContactMartin Srp, PhD
Outcome results
None listed