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A randomized controlled study of the effect of respiratory muscle training on cardiopulmonary function in Duchenne muscular dystrophy

A randomized controlled study of the effect of respiratory muscle training on cardiopulmonary function in Duchenne muscular dystrophy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082450
Enrollment
Unknown
Registered
2024-03-29
Start date
2024-03-30
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne muscular dystrophy

Interventions

1:The respiratory muscle function training was added on the basis of conventional physical therapy, and the breathing training was carried out by using the Sike Xiaokun breathing trainer. First, the r
2:Conventional physical therapy with no respiratory muscle interventions.

Sponsors

West China Second University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1) Presence of antimyotrophic protein gene mutation diagnosed by genetic examination and/or presence of decreased or absent antimyotrophic protein expression confirmed by muscle biopsy; 2) Male children between the ages of 6 and 12 years; 3) Ambulatory; 4) The measured value of MIP was 30%-90% of the predicted value or the measured value of FVC was 30%-90% of the predicted value, where the predicted value of MIP (cmH2O) = 153 + (-1.27 × age) + (0.131 × body weight), and the predicted value of FVC (L) = 0.93 × 1.1 × ((0.0576 × height) - (0.0269 × age) - 4.34); 5) Can cooperate to complete active rehabilitation training; 6) Written informed consent signed by the child or the child's family.

Exclusion criteria

Exclusion criteria: 1) Lung infection and lung injury within the last 3 months; 2) Combination of other neurodevelopmental disorders (e.g. autism spectrum disorders, language disorders, etc.); 3) Comorbidity with other neuromuscular disorders (e.g., dermatomyositis, myasthenia gravis, peripheral neuropathy, etc.); 4) Those with a combination of severe mood disorders, aggressive behavior, and oppositional defiance; 5) Those who withdraw from or fail to complete the treatment in the middle of the program.

Design outcomes

Primary

MeasureTime frame
Spirometry;

Secondary

MeasureTime frame
Six-minute walking test (6MWT);End-tidal carbon dioxide pressure (EtCO2);North Star Ambulatory Assessment (NSAA);respiratory muscle strength;Functional timing test (10 m run/walk test);Anthropometric indicators;

Countries

China

Contacts

Public ContactLinyuhan Zhou

West China Second University Hospital

2022224020149@stu.scu.edu.cn+86 182 2589 1614

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026