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

NCT06363526 | Enrolling By Invitation

• 1 other identifier: UMalagaDRIP
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Analyze the improvement of the forced vital capacity (FVC).

  Forced vital capacity is a respiratory parameter which is obtained from spirometry and which provides objective, valid information. It will be performed using spirometry before and after the digital respiratory intervention program. The spirometer that will be used is the "EasyOne Air Spirometer that complies with ISO 26782 standards, following the national spirometric recommendations of the ATS/ERS 2019.

  Baseline, up to 5 weeks.

Secondary Outcomes (10)

• Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination.

  Baseline, up to 5 weeks.

• Perform an anthropometric study of the patient's characteristics, taking into account age.

  Baseline, up to 5 weeks.

• Perform an anthropometric study of the patient's characteristics, taking into account height.

  Baseline, up to 5 weeks.

• Perform an anthropometric study of the patient's characteristics, taking into account sex.

  Baseline, up to 5 weeks.

• Examine changes in forced expiratory pressure

  Baseline, up to 5 weeks.

Study Arms (1)

Patients with Duchenne muscular dystrophy and Becker muscular dystrophy

EXPERIMENTAL

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

Other: Digital respiratory intervention program

Interventions

Digital respiratory intervention program 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.

Patients with Duchenne muscular dystrophy and Becker muscular dystrophy

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Rocío Martín-Valero

Málaga, Spain

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Muscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rocío Martín-Valero, PhD

  University of Malaga

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 12, 2024
• Study Start: February 5, 2025
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)