Effectiveness of 5-week Digital Respiratory Practice in Children With Duchenne and Becker Muscular Dystrophies.

NCT ID: NCT06363526

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2025-12-30

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.

Conditions

Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Muscular Dystrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Duchenne muscular dystrophy and Becker muscular dystrophy

A group of 12 patients with Duchenne muscular dystrophy and Becker muscular dystrophy that will be following a digital respiratory physiotherapy program.

Group Type: EXPERIMENTAL

Digital respiratory intervention program

Intervention Type: OTHER

A 4 times a week for a period of 5 weeks will be done, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. Moreover, 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.

The intervention program is carried out and stimulated through videos and therapeutic teaching to the caregivers in the first evaluation session, as well as as well as with a weekly follow-up using WhatsApp or Zoom as forms of communication, or a telephone call to ensure correct follow-up of the intervention program. Moreover, YouTube videos, own videos prepared by the physiotherapy will be used to help optimally resolve doubts that arise when carrying out the program by video call.

Interventions

Digital respiratory intervention program

A 4 times a week for a period of 5 weeks will be done, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. Moreover, 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.

The intervention program is carried out and stimulated through videos and therapeutic teaching to the caregivers in the first evaluation session, as well as as well as with a weekly follow-up using WhatsApp or Zoom as forms of communication, or a telephone call to ensure correct follow-up of the intervention program. Moreover, YouTube videos, own videos prepared by the physiotherapy will be used to help optimally resolve doubts that arise when carrying out the program by video call.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Rocío Martín Valero

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rocío Martín-Valero, PhD

Role: STUDY_DIRECTOR

University of Malaga

Locations

Rocío Martín-Valero

Málaga, , Spain

Countries

Spain

Other Identifiers

UMalagaDRIP

Identifier Type: -

Identifier Source: org_study_id