Duchenne Muscular DystrophyDMDrespy2024NCT06363526
Effectiveness of 5-week Digital Respiratory Practice in Children With Duchenne and Becker Muscular Dystrophies.
A study testing Digital respiratory intervention program in people with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Muscular Dystrophy
- What is being tested?
- Digital respiratory intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy.
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.
Read the 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.
- Being tested
- Digital respiratory intervention program
- Keywords
- Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Breathing exercises, Inspiratory muscle training, Pulmonary rehabilitation, Expiratory muscle training
- Medical subject headings
- Muscular Dystrophy, Duchenne, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital respiratory intervention programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digital respiratory intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
An anthropometric study of the patient's characteristics will be carried out, taking into account age, weight, as well as the average values that should be established based on age; as well as a general physical examination of the patient to analyze if they will be considered fit or not to carry out the program.
The weight will be check by "SECA 700 MECHANICAL COLUMN SCALE WITH SECA 220 STADIOMETER", and the height will be analyze by a measuring tape.
Measured: Baseline, up to 5 weeks.
Perform an anthropometric study of the patient's characteristics, taking into account age.
An anthropometric study of the patient's characteristics will be carried out, taking into account age, as well as the average values that should be established based on age; as well as a general physical examination of the patient to analyze if they will be considered fit or not to carry out the program.
Measured: Baseline, up to 5 weeks.
Perform an anthropometric study of the patient's characteristics, taking into account height.
An anthropometric study of the patient's characteristics will be carried out, taking into account height, as well as the average values that should be established based on age; as well as a general physical examination of the patient to analyze if they will be considered fit or not to carry out the program.
Measured: Baseline, up to 5 weeks.
Perform an anthropometric study of the patient's characteristics, taking into account sex.
An anthropometric study of the patient's characteristics will be carried out, taking into account height, as well as the average values that should be established based on sex; as well as a general physical examination of the patient to analyze if they will be considered fit or not to carry out the program.
Measured: Baseline, up to 5 weeks.
Examine changes in forced expiratory pressure
Forced expiratory pressure is a respiratory parameter obtained through spirometry, which provides important information about the patient's respiratory status. Measuring it will be done with the same characteristics as that previously mentioned in the FVC.
Measured: Baseline, up to 5 weeks.
Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP).
Changes in the strength of the inspiratory and expiratory muscles will be assessed using a pressure meter with a reading range of ±300 cm H20 and an accuracy of 3% (MicroRPM® model, Vyaire Medical GmbH, Hoechberg, Germany) following the national recommendations of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) (16).
Measured: Baseline, up to 5 weeks.
Check if there are changes in the sniff nasal inspiratory pressure (SNIP)
The existence of changes in the diaphragm force index is assessed, measuring it in exactly the same way as the MIP and PEM.
Measured: Baseline, up to 5 weeks.
Evaluate the fatigue in patients using an EPInfant test.
The amount of effort the child perceives during the sessions is assessed. It shows 11 descriptors numbered from 0 to 10 and 5 verbal descriptors located every 2 levels of the numbered descriptors, along with a drawing of a child doing physical activity in an increasing manner, increasing in intensity from left to right. The higher the numerical value, the worse the result is considered.
Measured: Baseline, up to 5 weeks.
Evaluate the quality of life of patients using a scale called "Kindscreen-52".
52-item scale carried out in Ravens-Sieberer U and validated in Spanish by Rajmil L, which assesses physical and psychological well-being, mood and emotions, self-perception, autonomy and relationship with friends and social life. . The scores were transformed into a scale from 0 to 100 to facilitate their interpretation: the higher the score, the higher HRQoL.
Measured: Baseline, up to 5 weeks.
North Star Ambulatory Assessment o NSAA
Designed to capture the construct of ambulatory function in DMD. 17-item scale that grades performance of various functional skills on a scale from 0 (unable), 1 (completes independently but with modifications), and 2 (completed without compensation). Total score 0 - 34 with a higher score denoting a higher level of function. It includes two timed tests. Timed rise from floor (RFF) and timed 10 metre walk / run test (10MWR). Validated and regularly used in clinical trials as well as clinic. Well understood by families. The best score is 34 points.
Measured: Baseline, up to 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start5 Feb 2025
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Martín Valero, University of Malaga
- Investigators
- Rocío Martín-Valero, PhD, Study director, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363526
- Sponsor's protocol ID
- UMalagaDRIP
- Acronym
- DMDrespy2024
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy.
- ClinicalTrials.gov ID
- NCT06363526
- Acronym / sponsor ID
- DMDrespy2024 / UMalagaDRIP
- Keywords
- Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Breathing exercises, Inspiratory muscle training, Pulmonary rehabilitation, Expiratory muscle training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with Duchenne muscular dystrophy and Becker muscular dystrophy | Experimental | Other: Digital respiratory intervention programA group of 12 patients with Duchenne muscular dystrophy and Becker muscular dystrophy that will be following a digital respiratory physiotherapy program. |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital respiratory intervention programA 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. | Other | Patients with Duchenne muscular dystrophy and Becker muscular dystrophy |
Primary outcome
Analyze the improvement of the forced vital capacity (FVC).
Time frame: Baseline, up to 5 weeks.
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.
10 secondary outcomes
Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination.
Time frame: Baseline, up to 5 weeks.
Perform an anthropometric study of the patient's characteristics, taking into account age.
Time frame: Baseline, up to 5 weeks.
Perform an anthropometric study of the patient's characteristics, taking into account height.
Time frame: Baseline, up to 5 weeks.
Perform an anthropometric study of the patient's characteristics, taking into account sex.
Time frame: Baseline, up to 5 weeks.
Examine changes in forced expiratory pressure
Time frame: Baseline, up to 5 weeks.
Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP).
Time frame: Baseline, up to 5 weeks.
Check if there are changes in the sniff nasal inspiratory pressure (SNIP)
Time frame: Baseline, up to 5 weeks.
Evaluate the fatigue in patients using an EPInfant test.
Time frame: Baseline, up to 5 weeks.
Evaluate the quality of life of patients using a scale called "Kindscreen-52".
Time frame: Baseline, up to 5 weeks.
North Star Ambulatory Assessment o NSAA
Time frame: Baseline, up to 5 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rocío Martín-Valero, PhD study director
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital respiratory intervention program in people with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the improvement of the forced vital capacity (FVC). (time frame: Baseline, up to 5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.