Status:
COMPLETED
DM-IMT - Controlled, Randomized, Three-arm Intervention Study on the Safety and Efficacy of Regular Respiratory Muscle Training in Patients With Myotonic Dystrophy Type 1
Lead Sponsor:
LMU Klinikum
Conditions:
Myotonic Dystrophy 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
For some diseases, regular respiratory muscle training could delay the start of ventilation. For DM1, however, there are no clinically high-quality studies. Only a case description from the year 2006 ...
Eligibility Criteria
Inclusion
- the patient is willing and able to provide a signed informed consent form
- the patient is ≥ 18 years old
- the diagnosis of type 1 myotonic dystrophy has been confirmed by molecular genetics
- the patient is able and willing to perform pulmonary function tests (PFT) and blood sampling for capillary blood gas analysis (pO2, pCO2) throughout the study, to keep a diary and to complete questionnaires
Exclusion
- the patient requires invasive ventilation (non-invasive ventilation is allowed).
- the patient uses non-invasive ventilation more than 16h/day.
- the patient participates in another clinical study that involves therapy.
- the patient cannot perform pulmonary function tests (PFT).
- the patient is diagnosed with central sleep apnea in polysomnography and not sufficiently treated with NIV ventilation.
- the patient is diagnosed with obstructive sleep apnea and not sufficiently treated with NIV ventilation.
- the patient cannot meet the requirements of the study, according to the investigator.
- the patient is unable to complete a 6-minute walking test
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04052958
Start Date
August 15 2019
End Date
December 31 2021
Last Update
May 2 2022
Active Locations (1)
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1
Friedrich-Baur-Institute, Dep. of Neurology Klinikum der Universitaet Muenchen Munich, Germany
Munich, Bavaria, Germany, 80336