Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
ID06481540

Effect of the SpiroGym App on Voluntary Cough Strength in Parkinson's Disease A Double-Blind Randomized Trial Comparing Expiratory Muscle Strength Training With and Without Visual Feedback

Led by General University Hospital, Prague · Updated on 2025-01-23

60

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effect of the SpiroGym app on voluntary cough strength in people with Parkinson's disease. This study follows a previous pilot that showed the app helped improve expiratory muscle strength training (EMST) and voluntary peak cough flow (PCF) after two weeks. The trial aims to compare the impact of EMST with visual feedback from the SpiroGym app to EMST alone, hypothesizing greater improvements in cough strength for those using the app. The study is designed as a double-blind, randomized controlled trial. Participants will use an expiratory muscle trainer device (EMST150) at home to perform intensive EMST. One group will train with the SpiroGym app providing visual feedback, while the other group will train without the app. Training occurs five days per week for eight weeks during an intensive phase, with five sets of five forceful expirations per session. Following this, both groups continue maintenance training for 16 weeks at least two days per week, also at home. During the study, voluntary peak cough flow will be measured before baseline, at baseline, and after 8 and 24 weeks of training to evaluate changes. Participants will be monitored for adherence and the effectiveness of training. The total participation duration spans 24 weeks, including the intensive and maintenance phases. Safety and outcomes will be carefully assessed throughout the trial.

CONDITIONS

Official Title

SpiroGym App-Aided Cough Rehabilitation

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Parkinsons disease
  • Stable dopaminergic medication with no dose changes for at least 1 month
Not Eligible

You will not qualify if you...

  • Other neurological disorders
  • Difficulty complying due to neuropsychological dysfunction (dementia with a Montreal Cognitive Assessment score less than 19)
  • Breathing disorders or diseases
  • Smoking in the past 5 years
  • Uncontrolled hypertension

AI-Screening

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Trial Site Locations

Total: 1 location

1

General University Hospital

Prague, Czechia, 120 00

Actively Recruiting

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Research Team

M

Martin Srp, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Expiratory Muscle Strength Training in Patients with Parkinson's Disease: A Pilot Study of Mobile Monitoring Application.

Martin Srp, Rebeka Korteová, Radim Kliment...

https://pubmed.ncbi.nlm.nih.gov/34631956

Effects of Expiratory Muscle Training and Air Stacking on Peak Cough Flow in Individuals with Parkinson's Disease.

Alvaro Reyes, Adrián Castillo, Javiera Castillo

https://pubmed.ncbi.nlm.nih.gov/31720808
Effect of the SpiroGym App on Voluntary Cough Strength in Parkinson's Disease A Double-Blind Randomized Trial Comparing Expiratory Muscle Strength Training With and Without Visual Feedback | DecenTrialz