Clinical trial NCT06363526: Effectiveness of 5-week Digital Respiratory Practice in Children With Duchenne and Becker Muscular Dystrophies.
Official title: Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Muscular Dystrophy
Keywords: Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Breathing exercises
Inspiratory muscle training
Pulmonary rehabilitation
Expiratory muscle training
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 12 participants were randomized to follow a digital respiratory physiotherapy program for 5 weeks. The participants were evaluated at the beginning and at the end of the study, and the results will be measured before and after each intervention during the study.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy.

Detailed description: It will be done 4 times a week for a period of 5 weeks, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. An intervention program will be used based on respiratory muscle training exercises, upper limb strength work, yoga, diaphragmatic awareness exercises, always trying to do them through the use of games, and even try to include exercises that use motor imagery.

It is advisable during intervention program to have a playful environment stimulated for the children, and that the intervention program is carried out and stimulated through videos and therapeutic teaching to the caregivers in the first evaluation session, as well as with a weekly follow-up using WhatsApp as forms of communication, or a telephone call to ensure correct follow-up of the intervention program.

It is essential that to carry out the intervention, videos obtained from YouTube, own videos prepared to explain the exercises in a playful way applied to children, and even other applications such as Spotify to work with music, will be used, being offered in case of Zoom calls may be necessary to help optimally resolve doubts that arise when carrying out the program by video call.

At the end of the respiratory digital physiotherapy program, variables will be evaluated by the principal examiner.

Eligibility criteria: Inclusion Criteria:

* Participants with Duchenne muscular dystrophy and patients with Becker muscular dystrophy will be chosen.
* Aged between 5 and 20 years.
* Child who could walk and follow the intervention program, and were diagnosed according to the International Classification of Diseases, 10 Revision. code (G71-01); and who had an NSSA score greater than 20.

Exclusion Criteria:

* Patients who present associated heart disease.
* Patients who presentor fractures, a heart rate greater than 120 beats per minute, or an oxygen saturation less than 89% will be excluded.
* Participants who do not have the capacity to have internet at home to perform the intervention, as well as all patients whose caregivers did not agree to sign the informed consent.

Primary outcomes:
measure: Analyze the improvement of the forced vital capacity (FVC).
timeFrame: Baseline, up to 5 weeks.
Secondary outcomes:
measure: Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination.
timeFrame: Baseline, up to 5 weeks.
measure: Perform an anthropometric study of the patient's characteristics, taking into account age.
timeFrame: Baseline, up to 5 weeks.
measure: Perform an anthropometric study of the patient's characteristics, taking into account height.
timeFrame: Baseline, up to 5 weeks.
measure: Perform an anthropometric study of the patient's characteristics, taking into account sex.
timeFrame: Baseline, up to 5 weeks.
measure: Examine changes in forced expiratory pressure
timeFrame: Baseline, up to 5 weeks.
measure: Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP).
timeFrame: Baseline, up to 5 weeks.
measure: Check if there are changes in the sniff nasal inspiratory pressure (SNIP)
timeFrame: Baseline, up to 5 weeks.
measure: Evaluate the fatigue in patients using an EPInfant test.
timeFrame: Baseline, up to 5 weeks.
measure: Evaluate the quality of life of patients using a scale called "Kindscreen-52".
timeFrame: Baseline, up to 5 weeks.
measure: North Star Ambulatory Assessment o NSAA
timeFrame: Baseline, up to 5 weeks.
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Rocío Martín-Valero
Study officials:
affiliation: University of Malaga
name: Rocío Martín-Valero, PhD
role: STUDY_DIRECTOR
References: