SpiroGym App-Aided Cough Rehabilitation (ESApp PD)

General University Hospital, Prague

Status: Enrolling

Conditions: Parkinson Disease; Voluntary Peak Cough Strength; mHealth

Treatments: Device: Expiratory muscle strength training; Device: Expiratory muscle strength training + SpiroGym application

Study type: Interventional

Funder types: Other

Identifiers

NCT06481540

ESApp PD

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Expiratory muscle strength training + SpiroGym application

Experimental group

Description:

The experimental arm will undergo 8 weeks of expiratory muscle strength training coupled with SpiroGym app.

Treatment:

Device: Expiratory muscle strength training + SpiroGym application

Expiratory muscle strength training

Active Comparator group

Description:

The experimental arm will undergo 8 weeks of expiratory muscle strength training.

Treatment:

Device: Expiratory muscle strength training