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E-monitoring of PULMonary Function in Patients With Duchenne Muscular Dystrophy at Home" (E-PULMoDMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05516745
Recruitment Status : Recruiting
First Posted : August 26, 2022
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Medical University of Gdansk

Brief Summary:
Duchenne muscular dystrophy (DMD) is the most common, progressive, irreversible muscular dystrophy. The pulmonary function is crucial for the duration of life in this disease. The European Respiratory Society is currently focused on digital health, seeking to define the realistic innovations for digital respiratory medicine to support professionals and patients during the COVID-19 pandemic. This study aimed to investigate whether it is possible to monitor pulmonary function at home by using an individual electronical spirometry system in children with Duchenne muscular dystrophy DMD. The second aim of the study is the implementation of respiratory telerehabilitation and the assessment of its impact on pulmonary function (FVC).

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy (DMD) Device: AioCare spirometer Other: telerehabiliation of the respiratory system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

4 arms -

  1. arm - AioCare device spirometry
  2. arm - AioCare device spirometry+ telerehabilitation of the respiratory system
  3. arm - telerehabilitation of the respiratory system
  4. arm - control arm - standard of care (no monitoring, no telerehabilitation)
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: E-monitoring of Pulmonary Function in Patients With Duchenne Muscular Dystrophy Undergoing Respiratory Rehabilitation at Home"
Actual Study Start Date : March 20, 2021
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : March 2025


Arm Intervention/treatment
Experimental: arm with intervention (AioCare spirometry)
50 participants with DMD aged 7-17 years, subjected to home electronic monitoring
Device: AioCare spirometer
In the first part of the trial, all participants from arms 1 and 2 will receive the AioCare spirometer (Healtup, Poland) to home-based monitoring pulmonary function. Hospital spirometry examinations (Jaeger, Germany) evaluating disease progression will be performed periodically. There are to be follow-up visits after 3 months and after 6 months. The end-point visit is planned for 12 months.

Experimental: arm with intervention (AioCare spirometry with telerehabilitation)
50 participants with DMD aged 7-17 years, subjected to home electronic monitoring with the AioCare device and pulmonary rehabilitation exercises
Device: AioCare spirometer
In the first part of the trial, all participants from arms 1 and 2 will receive the AioCare spirometer (Healtup, Poland) to home-based monitoring pulmonary function. Hospital spirometry examinations (Jaeger, Germany) evaluating disease progression will be performed periodically. There are to be follow-up visits after 3 months and after 6 months. The end-point visit is planned for 12 months.

Other: telerehabiliation of the respiratory system
A major component of respiratory dysfunction seems to be a decline of respiratory muscle weakness. The proposition is respiratory telerehabilitation to improve the function of respiratory muscles. Telerehabilitation includes breathing exercises for use at home. The participants will be trained in the hospital and will receive video presentations to support the exercises at home.

Experimental: arm with intervention (telerehabilitation)
50 participants with DMD aged 7-17 years, subjected to pulmonary rehabilitation exercises
Other: telerehabiliation of the respiratory system
A major component of respiratory dysfunction seems to be a decline of respiratory muscle weakness. The proposition is respiratory telerehabilitation to improve the function of respiratory muscles. Telerehabilitation includes breathing exercises for use at home. The participants will be trained in the hospital and will receive video presentations to support the exercises at home.

No Intervention: control arm (no intervention)
50 participants with DMD aged 7-17 years, subject to a standard of care



Primary Outcome Measures :
  1. Change from Baseline of the mean Forced Vital Capacity in Liters measured by home and hospital spirometry in DMD participants with vs without respiratory telerehabilitation [ Time Frame: 12 months ]
    Some studies showed that respiratory function declines at a rate of 6-11% annually in patients with DMD. A major component of respiratory dysfunction seems to be a decline of inspiratory muscle weakness. Methods of improving the functioning of the muscles of the respiratory system are constantly sought. One of the key factors that can improve the function of respiratory muscles is proper rehabilitation. The proposition is implementation of telerehabilitation of respiratory muscle together with e-monitoring pulmonary function at home.

  2. Change from Baseline of the mean Forced Vital Capacity in %predicted value measured by home and hospital spirometry in DMD participants with vs without respiratory telerehabilitation [ Time Frame: 12 months ]
    Some studies showed that respiratory function declines at a rate of 6-11% annually in patients with DMD. A major component of respiratory dysfunction seems to be a decline of inspiratory muscle weakness. Methods of improving the functioning of the muscles of the respiratory system are constantly sought. One of the key factors that can improve the function of respiratory muscles is proper rehabilitation. The proposition is implementation of telerehabilitation of respiratory muscle together with e-monitoring pulmonary function at home.


Secondary Outcome Measures :
  1. Possibility of home e-monitoring of pulmonary function in patients with Duchenne Muscular Dystrophy in the Covid-19 pandemic [ Time Frame: 4 weeks ]
    • number of the days with performed spirometry test per patient during the monitoring period
    • number and percent of correct spirometry parameters.

  2. The number of the participants who performed at least one correct spirometry examination [ Time Frame: 4 weeks ]
    Feasibility of home e-monitoring of pulmonary function in patients with Duchenne Muscular Dystrophy in the Covid-19 pandemic measured by The number of the participants who performed at least one correct spirometry examination

  3. the difference in the value of spirometry results (FVC %pv, L) between home spirometry and spirometry in the hospital [ Time Frame: 4 weeks ]
    Feasibility of home e-monitoring of pulmonary function in patients with Duchenne Muscular Dystrophy in the Covid-19 pandemic measured by The number of the participants who performed at least one correc the difference in the value of spirometry results (FVC %pv, L) between home spirometry and spirometry in the hospital



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male, ≥7 years and <18 years of age at the time of enrollment in the study;
  • ability to perform spirometry;
  • stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

  • no consent to participate in the study;
  • patients under 7 years of age or above 18 years of age;
  • inability to perform spirometry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05516745


Contacts
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Contact: Eliza Wasilewska, MD,PhD +48 56 349 2625 ewasilewska@gumed.edu.pl
Contact: Eliza Wasilewska, MD,PhD

Locations
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Poland
Medical University Recruiting
Gdańsk, Poland, 80-292
Contact: Eliza Wasilewska, MD,PhD    +48 56 349 2625    ewasilewska@gumed.edu.pl   
Sponsors and Collaborators
Medical University of Gdansk
Investigators
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Principal Investigator: Eliza Wasilewska, MD,PhD Medical University Gdansk
  Study Documents (Full-Text)

Documents provided by Medical University of Gdansk:
Study Protocol  [PDF] March 1, 2021

Additional Information:
Publications of Results:

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Responsible Party: Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT05516745    
Other Study ID Numbers: EPULMoDMD 001/2021
First Posted: August 26, 2022    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Gdansk:
AioCare spirometer
home spirometry
spirometry e-monitoring
pulmonary rehabilitation
digital medicine
e-health
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Respiratory System Agents