Effect of SpiroGym App in Patients With Parkinson's Disease (RespPD)

February 10, 2023 updated by: Martin Srp, Ph.D., General University Hospital, Prague

Effect of SpiroGym Mobile Application in Expiratory Muscle Strength Training in Patients With Parkinson's Disease: a Double Blind Randomised Control Trial

Airway protective disorders, including swallowing (dysphagia) and cough (dystussia) are common in patients with Parkinson's disease (PD). Disturbances in these protective mechanisms increase the risk of aspiration pneumonia. In fact, aspiration pneumonia is the leading cause of death in individuals with PD. Expiratory muscle strength training (EMST) studies have reported significant improvements in the field of airway protective therapies. EMST represents a treatment that can be quantified and translated into functional outcomes that can directly improve functions related to coughing, swallowing, and speech in patients with PD. However, information about detraining outcomes presented in Troche et al. 2014 highlights the need for the development of long-term maintenance programs to sustain training gains following intensive periods of EMST, especially considering the progressive nature of PD. Low long-term adherence to home exercise is an important issue in many patient groups and may compromise treatment outcomes. In patients with PD, this is further compounded by a wide variety of neuropsychiatric symptoms, such as apathy and depression. Therefore, we developed a mobile phone-based visual feedback application (SpiroGym app.) to keep patients motivated to continue EMST following intensive periods of training. The usability of a SpiroGym app was tested in individuals with PD and the findings indicate that EMST coupled with SpiroGym app is feasible and potentially useful in PD patients. Present study aims to verify and extend the encouraging results of this study which showed a potential self-efficacy benefit of the SpiroGym application.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Goal 1: To explore effect of the SpiroGym apllication on treatment adherence in 24weeks home expiratory strength training.

Hypothesis: Treatment adherence will be higher in the experimental group than in the active control group.

Goal 2: To explore self-efficacy effect of the SpiroGym aplication in expiratory muscle training.

Hypothesis: The SpiroGym application will increase self-eficacy for expiratory muscle strength training.

Goal 3: To explore additional visual feedback effect of the SpiroGym application to increase training effort compared with regular training without immediate visual feedback.

Hypothesis: Visual feedback of the SpiroGym application will increase training effort in expiratory muscle strength trainning which will be reflected in the MEP values at 8weeks assessment and 24weeks assessment.

Study design: a double blind randomised-controlled trial

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 120 00
        • Recruiting
        • General University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Parkinsons disease
  • Stable dopaminergic medication (stable dose for at least 1 month)
  • Patient in the risk of non-adherence to the home exercise program (SEHEPS questionnaire below 59 points)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Expiratory muscle strength training + SpiroGym application
The experimental arm will undergo 24 weeks of expiratory muscle strength training coupled with SpiroGym app.
Device: Expiratory muscle strength training + SpiroGym application
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). For another 16 weeks (maintenance period) participants will be instructed to perform, at least twice per week, five sets of five forceful expirations coupled with SpiroGym app. per training session .
ACTIVE_COMPARATOR: Expiratory muscle strength training
The experimental arm will undergo 24 weeks of expiratory muscle strength training.
Device: Expiratory muscle strength training
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). For another 16 weeks (maintenance period) participants will be instructed to perform, at least twice per week, five sets of five forceful expirations per training session. Participants will be given the practice log to track training adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: Adherence for home exercise programs from baseline to end of the study (24 weeks)
Adherence will be calculated by comparing the total amount of expiratory maneuvers recorded in the patient training logs (active control group) or in the SpiroGym application (experimental group) to the prescribed amount: 1000 manoeuvres during baseline to week 8 and 800 manoeuvres during weeks 8-24.
Adherence for home exercise programs from baseline to end of the study (24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum expiratory pressure (MEP)
Time Frame: 1 week before baseline, baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 24 weeks
MEP assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines. Assessments will be performed using a flanged rubber mouthpiece connected to a pressure manometer (Micro RPM, Micro Medical).The maximum value of three expiratory maneuvers that vary by less than 10%. However, results of published studies confirms a learning effect in the MEP measurements. In order to eliminate the learning effect, the patients will be examined twice within one week. The value from the second measurement will be taken as the baseline MEP value. Aditionaly to decrease the test's variability, a 'warm up session' will be incorporated prior to MEP measurements.
1 week before baseline, baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 24 weeks
The Self-Efficacy scale for home exercise programs
Time Frame: baseline, 8 weeks
The Self-Efficacy scale for home exercise programs is a tool for evaluating a patient's self-efficacy for home-based exercise programs. The minimum value is 0 and the maximum value is 72. Higher score mean higher self-efficacy for performing home exercise programs.
baseline, 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-Unified Parkinson's Disease Rating Scale: part III.
Time Frame: Baseline, 8 weeks and 24 weeks
This portion of the scale assesses the motor signs of Parkinson´s disease. The minimum value is 0 and the maximum value is 132. Higher score mean The minimum value is 0 and the maximum value is 72. Higher score mean higher patient motor disability.
Baseline, 8 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General University Hospital, Prague

Investigators

  • Principal Investigator: Martin Srp, Ph.D., General University Hospital, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2022

Primary Completion (ANTICIPATED)

November 1, 2024

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (ESTIMATE)

February 14, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223/20 S-IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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